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. 2021 Aug 26;16(8):e0256747. doi: 10.1371/journal.pone.0256747

“Mass gathering events and COVID-19 transmission in Borriana (Spain): A retrospective cohort study”

Salvador Domènech-Montoliu 1, Maria Rosario Pac-Sa 2, Paula Vidal-Utrillas 3, Marta Latorre-Poveda 1, Alba Del Rio-González 3, Sara Ferrando-Rubert 3, Gema Ferrer-Abad 3, Manuel Sánchez-Urbano 1, Laura Aparisi-Esteve 4, Gema Badenes-Marques 1, Belén Cervera-Ferrer 1, Ursula Clerig-Arnau 1, Claudia Dols-Bernad 5, Maria Fontal-Carcel 6, Lorna Gomez-Lanas 1, David Jovani-Sales 4, Maria Carmen León-Domingo 7, Maria Dolores Llopico-Vilanova 1, Mercedes Moros-Blasco 4, Cristina Notari-Rodríguez 1, Raquel Ruíz-Puig 1, Sonia Valls-López 1, Alberto Arnedo-Pena 2,8,9,*
Editor: Simone Lolli10
PMCID: PMC8389516  PMID: 34437628

Abstract

Objective

Mass gathering events (MGEs) are associated with the transmission of COVID-19. Between 6 and 10 March 2020, several MGEs related to the Falles festival took place in Borriana, a municipality in the province of Castellon (Spain). The aim of this study was to estimate the incidence of COVID-19 and its association with these MGEs, and to quantify the potential risk factors of its occurrence.

Methods

During May and June 2020, a population-based retrospective cohort study was carried out by the Public Health Center of Castelló and the Hospital de la Plana in Vila-real. Participants were obtained from a representative sample of 1663 people with potential exposure at six MGEs. A questionnaire survey was carried out to obtain information about attendance at MGEs and COVID-19 disease. In addition, a serologic survey of antibodies against SARS-Cov-2 was implemented. Inverse probability weighted regression was used in the statistical analysis.

Results

A total of 1338 subjects participated in the questionnaire survey (80.5%), 997 of whom undertook the serologic survey. Five hundred and seventy cases were observed with an attack rate (AR) of 42.6%; average age was 36 years, 62.3% were female, 536 cases were confirmed by laboratory tests, and 514 cases were found with SARS-CoV-2 total antibodies. Considering MGE exposure, AR was 39.2% (496/1264). A dose-response relationship was found between MGE attendance and the disease, (adjusted relative risk [aRR] = 4.11 95% confidence interval [CI]3.25–5.19). Two MGEs with a dinner and dance in the same building had higher risks. Associated risk factors with the incidence were older age, obesity, and upper and middle class versus lower class; current smoking was protective.

Conclusions

The study suggests the significance of MGEs in the COVID-19 transmission that could explain the subsequent outbreak in Borriana.

Introduction

Mass gathering events (MGEs) are important risk factors of severe acute respiratory coronavirus 2 (SARS-CoV-2) transmissions, which causes coronavirus disease 2019 (COVID-19) pandemic [1]. According to the World Health Organization [2] “Mass gatherings are events characterized by the concentration of people at a specific location for a specific purpose over a set period of time that have the potential to strain the planning and response resources of the host country or community”. MGEs cover different types of event and contexts such as public and private celebrations, festivals, religious events and pilgrimages, sporting and touristic events, and political meetings. The crucial role of MGEs in the global propagation of the disease has been evidenced in several countries, including China [3], Iran [4], Malaysia [5], Italy [6], Spain [7], France [8], Germany [9], Jordan [10], Malta [11], Switzerland [12], and Malawi [13]. Significant international efforts have been made to implement specific measures, risk assessment and surveillance, and event cancellations in order to prevent the spread of SARS-CoV-2 from MGEs [1417]. The propagation of SARS-CoV-3 in these MGEs was measured with the basic reproductive number (Ro), which reflects the efficiency of transmission of the disease [18], and “is defined as the expected number of secondary cases produced by a single (typical) infection in a completely susceptible population” [19]. A meta-analysis of medical literature estimated a Ro = 3.38±1.40 from a range of 1.90–6.49 for the COVID-19 pandemic [20].

MGEs imply the gathering of people in restricted spaces, either indoor or outdoor, over a prolonged period of time, where food and/or drink are generally consumed, usually in close proximity to others, and involving the movement of populations [14, 2123]. The conditions of MGEs have been associated with the spread of SARS-CoV-2, but few MGE studies [24, 25] have published quantification and adjustment for potential risk factors. In addition, several epidemiologic biases such as selection and misclassification have been observed in some studies of SARS-CoV-2 outbreaks, considering the novelty of the disease and the emergency situation [26].

Spain has had a high incidence of COVID-19 [27, 28], with a large number of COVID-19 outbreaks occurring in households, nursing homes, hospitals, workplaces and leisure facilities [2933]. We studied a MGE COVID-19 outbreak that took place in the first wave of the pandemic. During March and April 2020 in Borriana, a municipality with 34,683 inhabitants located in the province of Castellon in the Valencian Community (Spain), a COVID-19 outbreak occurred with an incidence of 260 cases (749.6 cases per 100,000 inhabitants) confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) [34]. Between February and the first days of March 2020, before the COVID-19 outbreak in Borriana, several MGEs took place in connection with the traditional Falles festival, which is held annually in Borriana. Our hypothesis was that the MGEs held during the Falles festival were associated with the COVID-19 outbreak in Borriana.

Using a population-based retrospective cohort study, we aimed to estimate the association of the incidence of COVID-19 disease with the MGEs in Borriana, and quantify potential risk factors of its occurrence.

Material and methods

Description of MGEs during the Falles festival in Borriana

Borriana is a municipality located 5.7 km from the Mediterranean Sea in the province of Castellon, Spain. A series of MGEs took place between March 6 and 10, 2020 during the traditional Falles festival in Borriana. This popular festival is organized by people in the town’s different neighborhoods, clustered in social groups, known as a “falla” (singular) or “falles” (plural), with the purpose of bringing the festivities to the streets. Falles groups consider themselves as a large family. Their final objective is to build a monument with humorous scenes of daily life, which is burned on March 19 [35, 36]. During the 2020 festivities, 19 falles with a total of 2800 members were active in Borriana; each group had between 26 and 384 people and a median of 143 members. The members of the falles comprise around 8.1% of Borriana’s population.

The MGEs analyzed in this study took place in three locations: building A, purposely designed for MGEs with a surface area of 1670 m2 and a capacity of 900 people (three events); theater B (two events and a capacity of 884), and an outdoor square in the city of Valencia. Building A and theater B had air conditioning and ventilation equipment. The MGEs are described below:

First, a pa-i-porta (‘bring your own’ supper) (building A; March 6), a community dinner with an estimated total attendance of approximately 1400 people over a seven hour period (9:30 p.m. to 4:30 a.m.) and dancing after midnight.

Second, the Queen’s gala dinner (building A; March 7), with 400 people gathered together over six and a half hours (10:00 p.m. to 4:30 a.m.) and dancing after midnight. A detailed list of attendees and their distribution in building A was available.

Third, a trip to see fireworks in a square in Valencia (March 8). About 800 people gathered for half an hour (at 2:00 p.m.).

Fourth, a senior citizens’ dance (building A; March 8). Around 100 people attended for one and a half hours (5:30 p.m. to 7:00 p.m.).

Fifth, the theater awards gala (theater B; March 8): indoor show attended by 300 people for two hours (7:00 p.m. to 9:00 p.m.).

Sixth, the Queen’s offering (theater B; March 10): a show attended by 400 people for one and a half hours (10:30 p.m. to 0:00 a.m.).

A summary of the characteristics of these MGEs is presented in Table 1.

Table 1. Characteristics of Mass Gathering Events (MGEs) connected to the Falles festival in Borriana from March 6 to 10.

MGEs Location Date Hours People in attendance Activities
Pa-i-porta supper Building A 3/6/2020 7.00 14001 Dinner and dance
Queen’s gala dinner Building A 3/7/2020 6.30 400 Dinner and dance
Trip to Valencia Square outdoor 3/8/2020 0.30 800 Attendance
Senior citizen’s dance Building A 3/8/2002 1.30 100 Dance
Theater awards gala Theater B 3/8/2020 2.00 300 Attendance
Queen’s offering Theater B 3/10/2020 1.30 400 Attendance

1. Throughout the duration of the MGE.

Design of the study

A population-based retrospective cohort study was carried out from May 14 to June 31, 2020 in Borriana. The study was jointly designed by the Public Health Center of Castellon and the Emergency Service of the Hospital de la Plana (HP) in Vila-real. The study had two phases: 1) a survey with a specific questionnaire to estimate the incidence of COVID-19, and 2) a serologic study of antibodies against SARS-CoV-2 to confirm cases with laboratory tests and to uncover the extent of the infection and the epidemic situation.

Questionnaire survey

In the first phase, starting on May 14, 2020, a standardized questionnaire was administered to obtain information about MGE exposure, demographic characteristics, occupation, habits, health condition, symptoms of the disease, the evolution of COVID-19 disease, previously conducted COVID-19 laboratory tests, and family members affected by COVID-19. The study period covering COVID-19 cases ranged from January 1 to June 31, 2020. The questionnaire was completed through a telephone survey carried out by the health staff of HP, Borriana health centers, and other health centers in the Health Department of La Plana in Vila-real, Castellon. In the telephone survey, parents were requested to ask the questions to their children when a child had been chosen in the simple random sampling. In general, parents were able to answer the questionnaire. Social class was estimated from occupations; children’s social class was that of their parents. Two groups were considered: I and II included professional, managerial and technical occupations (upper and middle class); group III-VI included skilled, non-manual or manual, semi-skilled, and unskilled occupations (lower class).

Participants were recruited from two sources. First, a representative sample of the 19 falles (n = 2800 members) was obtained by simple random sampling with design effect 1 and 19 clusters (one per falla), considering an attack rate of COVID-19 disease of 50% in MGEs, a confidence level of 80%, and an alpha error 5%. The sample comprised 1558 people, which corresponds to 82 people per falla for those with a population larger than 82, or all the members of the falla for those with a population smaller than 82. The Open-Epi program [37] was used to randomly select the participants from a numbered list of all members of each falla until 82 people, including adults and children, were obtained. The phone numbers of each selected participant or their family member were then obtained from the Borriana Falles organization. Second, in order to maximize the number of participants from the Queen’s gala dinner (n = 400), given that the complete list of attendees to the event was available, an additional random sample of 105 people from the list of diners was recruited. The same procedure described above was used to randomly select the 105 people.

Serologic survey and laboratory tests

During the second phase, a serologic survey of anti-SARS-CoV-2 antibody prevalence was carried out from 23 to 27 June 2020 by the Clinical Analysis and Microbiology Service (CAMS) of HP. Qualitative detection of antibodies against SARS-CoV-2 was carried out by an electrochemiluminescence immunoassay (ECLIA) (Elecsys® Anti-SARS-CoV-2, Roche Diagnostics) [38]. IgG and IgM antibodies against SARS-CoV-2 were detected by a lateral flow immunochromatographic assay (LFIC) (Healgen Scientific LLC for COVID-19 IgG/IgM rapid test cassette) [39].

Additionally, information about previously conducted laboratory tests for COVID-19 was gathered during the questionnaire survey. These data consisted of 1) RT-PCR tests, including LightMix® Modular Sarbecovirus E-gene with the LightCycler® 480 II system (Roche, Basel, Switzerland) [40], 2) ECLIA with LFIC, and 3) rapid anti-SARS-CoV-2 antibody tests. These tests were conducted by HP and other public and private laboratories.

Case definitions

A probable COVID-19 case was defined as a patient who presented clinical and epidemiological criteria of COVID-19 disease during the study period, according to the case-definition proposed by the Center for Disease Control and Prevention [41]. Clinical and epidemiological criteria must fulfill two conditions. The first is the reporting of at least two of the following symptoms: fever, chills, rigors, myalgia, headache, sore throat, and new olfactory and taste disorder; or one of the following symptoms: cough, shortness of breath, or difficulty breathing; or severe respiratory illness such as pneumonia or acute respiratory distress syndrome. The second condition is contact with a confirmed COVID-19 patient, or living in an area where a COVID-19 outbreak has been reported.

A confirmed COVID-19 case was defined as a patient who had positive antibodies of SARS-CoV-2 by ECLIA with LFIC, positive PCR, or positive rapid anti-SARS-CoV-2 antibody tests during the study period.

Non-cases (negative cases) were defined as participants who had no COVID-19 clinical criteria or had negative COVID-19 test results during the study period.

Statistical methods

The program Epi-Info® version 7 [42] was used to calculate the sample size. COVID-19 attack rates (AR) were estimated as the quotient between cases and total exposed population, considering different variables. To estimate the risk of the MGEs, COVID-19 cases with onset of symptoms between March 6 and 31, 2020 were included. The pa-i-porta and Queen’s gala dinner MGE events were analyzed in greater detail than the other events, considering the attendance population and the potential risk of COVID-19. Chi2 and Fisher’s exact test were used in the comparisons among variables.

Associations of risk factors with COVID-19 were measured by the relative risk (RR) using Poisson regression and multilevel Poisson regression, considering falles as a level group with a 95% confidence interval (CI). In order to adjust for potential confounding factors, the directed acyclic graphs (DAGs) method [43] was used with the DAGitty® program (version 3.0) [44], together with inverse probability weighted regression [45] to obtain adjusted AR (aAR) and RR (aRR). The DAG provides a picture of the relationship between an exposure (mass gathering event) and an outcome (COVID-19 disease) and factors that could be potential confounders. An adjustment was made for these factors. The factors were age, sex, social class (upper and middle class versus lower class), chronic illness, family COVID-19 case and falla (social group); all these factors could alter the relationship between exposure and outcome. In addition, a sensitivity analysis was carried out including participants who were tested for COVID-19 disease, to gain more specificity of the results. The Stata ® program (version 14) [46] was used in the calculation.

Ethical aspects

The study was approved by the director of the Public Health Center of Castellon and the management of the Health Department of La Plana, taking into account the situation of the COVID-19 pandemic in the province of Castellon. Participation was voluntary, and after an explanation of the study objective, oral informed consent was obtained from all participants (or their parents, in the case of minors) included in the study. To ensure explicit consent, several clarifications were made before administering the survey questionnaire, including voluntary participation, the option to withdraw from the study without prejudice, the opportunity to receive information about the study, a guarantee that personal information would be kept in the strictest confidentiality and that privacy would be safeguarded as the data collected would be used anonymously for scientific research; the researcher responsible for data collection was identified. When a child was selected in the sampling process, permission to participate was requested from their parents, who would also help them to answer the questionnaire; all the above clarifications were also made before the survey questionnaire was administered.

Results

Description of participants in the questionnaire survey

Participation rates in the questionnaire survey were 80.5% (1338/1663) (Fig 1). Participation was higher among females than males (58.9% versus 41.1%). The mean age was 33.9 ± 17.8 years (rank of 1–80 years) (Table 2). The most represented age groups were 45–64 years (28.2%) and 15–24 years (20.1%), and the least represented groups were 1–4 years (2.3%) and 65 years and above (3.4%) (Table 2). The occupation III-VI group (lower class) was higher than the I-II group (upper and middle classes) (74.3% versus 25.7%) (Table 2). Chronic illness was present in 30.9% of participants. The pa-i-porta event was the most highly attended MGE (60.5%), followed by the Queen’s gala dinner (24.8%). The theater award gala (12.4%) and the senior citizens’ dance (2.8%) had the lowest attendances (Table 2). A total of 397 participants in the questionnaire survey (25.3%) did not attend any MGEs.

Fig 1. Flow diagram of the study population in the MGEs in Borriana between January and June 2020.

Fig 1

COVID-19 cases included those diagnosed by laboratory tests (confirmed cases) or by clinical and epidemiological criteria (probable cases). Cases confirmed by laboratory tests included participants with positive results from the serologic survey as well as from private and public medical laboratories.

Table 2. Characterization of the participants included in the study of Mass Gathering Events (MGEs) from January 1 to June 31, 2020, Borriana.

Variable Participants (n) Participants1 (%) COVID-19 tests (n) COVID-19 tests (%)
Total participants 1338 - 1132 84.61
Female 788 58.9 680 60.1
Male 550 41.1 452 39.9
Mean age ± SD2 33.9 ± 17.8 - 36.9 ± 17.1 -
Age (years)
0–4 31 2.3 20 1.8
5–14 190 14.2 137 12.1
15–24 269 20.1 217 19.2
25–34 185 13.8 157 13.9
35–44 241 18.0 213 18.8
45–64 377 28.2 349 30.8
65 and above 45 3.4 39 3.4
Social class3,4
Occupation I-II 339 25.7 283 25.0
Occupation III-VI 978 74.3 840 74.2
Chronic illness5
Yes 411 30.9 364 32.2
No 920 69.1 763 67.4
MGE total attendees
Pa-i-porta (n = 1400) 809 (57.8%) 60.5 740 65.4
Queen’s gala dinner (n = 400) 332 (83.0%) 24.8 317 28.0
Valencia trip (n = 800) 211 (26.4%) 15.8 190 16.8
Queen’s offering (n = 400) 239 (59.8%) 17.9 230 20.3
Senior citizens’ dance (n = 100) 38 (38.0%) 2.8 38 3.4
Theater awards gala (n = 300) 166 (55.3%) 12.4 151 13.3
No attendance 397 25.3 274 24.2

1. Of total participants.

2. Standard deviation.

3. Occupation group I and II: Professional, managerial and technical occupations (upper and middle class); Group III-VI: Skilled, non-manual or manual; semi-skilled; unskilled occupations (lower class).

4. Missing answer from 21 participants.

5. Missing answer from 7 participants.

Description of participants in the serologic survey and COVID-19 laboratory tests

A total of 1132 participants (84.6%) underwent laboratory tests for COVID-19 disease (Table 2), considering both the tests carried out as part of the serologic survey (n = 997) and those from private and public medical laboratories (n = 135) (Fig 1, see Methods for further information). Participation rates in the serologic survey were 74.5% (997/1338). Female participation in laboratory tests for COVID-19 (including both the serologic survey and medical records) was higher (60.1%) than that of males (39.9%). The mean age of participants that underwent a COVID-19 laboratory test was 36.9 ± 17.1 years. The 45–64 years and 15–24 years age groups were the most highly represented (30.8% and 19.2%, respectively), while 0–4 years (1.8%) and 65 years and above (3.4%) were the least represented (Table 2). Participation of the occupation III-VI group (lower class) was higher than in the I-II group (upper and middle class) (74.2% versus 25.0%) (Table 2). A total of 32.2% of the participants reported suffering from a chronic illness (Table 2). MGE attendance among participants with COVID-19 laboratory tests showed the pa-i-porta event as the most highly attended event (65.4%), again followed by the Queen’s gala dinner (28.9%), while the theater award gala (13.3%) and the senior citizens’ dance (3.4%) had the lowest attendance (Table 2). A total of 274 participants (24.1%) with COVID-19 laboratory tests did not attend any MGEs (Table 2).

Description of COVID-19 outbreak

During the study period, 570 COVID-19 cases were found (Fig 1, Table 2). Among these, 536 (94.0%) were confirmed cases with positive COVID-19 laboratory tests and 34 (6.0%) were probable cases as diagnosed according to clinical and epidemiological criteria (Fig 1). Specifically, confirmed cases included 514 participants (90.2%) with positive total anti-SARS-CoV-2 antibodies (32 of whom also reported a positive PCR test), seven participants (1.2%) with positive PCR only (a total of 39 participants had a positive PCR, 6.8%), and 15 participants (2.6%) with positive rapid anti-SARS-CoV-2 antibody tests. From the subset of 997 participants in the serologic survey, 508 were positive for anti-SARS-CoV-2 IgG antibodies, and eight participants were also positive for anti-SARS-CoV-2 IgM antibodies. AR was 42.6% (570/1338) among total participants, 47.3% (536/1132) among participants undergoing laboratory tests, and 16.5% (34/206) among those classified according to clinical and epidemiological criteria (Fig 1).

The temporal distribution of confirmed and probable COVID-19 cases is shown by onset of symptoms (Fig 2). The first cases were reported on 28 and 29 January 2020. The incidence then slowly progressed during February with a small peak of cases on March 2. Two maximum peaks of cases occurred on March 9 (45 cases) and March 16 (49 cases). After April, only isolated cases were reported, which is consistent with the general lockdown in Spain that was implemented on March 15. According to these observations, the distribution of COVID-19 cases in this study showed a bimodal epidemic curve with two maxima. Interestingly, the aforementioned peaks took place between 3 and 10 days after the MGEs (see Methods for further information). This indicates several point sources of the outbreak, with the pa-i-porta and Queen’s gala dinner events being the first ones on March 6 and 7, respectively.

Fig 2. Temporal distribution of COVID-19 cases by onset of symptoms.

Fig 2

The numbers of confirmed and probable COVID-19 cases are shown in blue and orange, respectively. The yellow vertical line highlights the time period when the six MGEs took place (March 6–10, 2020).

Epidemiological characterization of COVID-19 cases

Regarding the sex of total cases, 355 (62.3%) were female and 215 (37.7%) were male (Table 3). The AR for males (39.1%) was smaller than for females (45.1%) (RR = 0.87, 95% CI 0.73–1.03) (Table 2). Similarly, COVID-19 incidence was lower in males than in females for both confirmed (44.9% versus 49.0%) and probable cases (12.2% versus 20.4%), although differences in AR were not significant.

Table 3. Characteristics of patients of COVID-19.

From January 1 to June 31, 2020, Borriana.

Variables Cases Non-cases Total AR1 (%) RR (95% IC)2 p-value
Total cases 570 768 1338 42.6 - -
PCR positive 39 1299 1338 2.9 - -
Hospitalizations 13 1325 1338 1.0 - -
Deaths 1 1337 1338 0.07 - ´-
Sex
Male 215 335 550 39.1 0.87(0.73–1.03) 0.110
Female 355 433 788 45.1 1.00
Age mean ± SD3 36.4±17.1 32.0±18.0 1.01 (1.00–1.01) 0.001
Age groups (years)
0–4 8 23 31 25.8 1.00
5–14 58 133 190 30.5 1.11(0.56–2.44) 0.685
15–24 110 159 269 41.1 1.54(0.75–3.17) 0.243
25–34 72 113 185 38.9 1.48(0.71–3.08) 0.293
35–44 114 127 241 47.3 1.80(0.88–3.68) 0.110
45–64 189 188 377 50.1 1.92(0.94–3.90) 0.073
65 and above 19 26 45 42.2 1.56(0.68–3.57) 0.297
Confirmed cases
Male 203 249 452 44.9 0.91(0.77–1.09) 0.322
Female 333 347 680 49.0 1.00
Probable cases
Male 12 86 98 12.2 0.63(0.30–1.28) 0.200
Female 22 86 108 20.4 1.00
Asymptomatic
Male 30 520 550 5.5 1.17(0.72–1.90) 0.519
Female 37 751 788 4.7 1.00
Family with COVID-194 Yes 347 254 601 57.7 1.91(1.59–2.23) <0.001
No 221 506 727 30.4 1.00
Medical assistance Yes 247 94 341 72.4 2.22(1.88–2.62) <0.001
No 323 674 997 32.1 1.00
Chronic illness5 Yes 189 222 411 46.0 1.13(0.95–1.35) 0.183
No 375 545 920 40.8 1.00
Diabetes Mellitus6 Yes 10 18 28 35.7 0.84(0.45–1.56) 0.574
No 552 743 1295 42.6 1.00
Cardiovascular diseases6Yes 69 66 135 51.1 1.23(0.95–1.58) 0.114
No 493 695 1188 41.5 1.00
Hypertension6 Yes 47 51 98 48.0 1.14(0.84–1.54) 0.393
No 514 711 1225 42.0 1.00
Hypothyroidism7 Yes 28 22 50 56.0 1.32(0.90–1.94) 0.150
No 534 740 1274 41.9 1.00
Digestive diseases6 Yes 16 15 31 51.6 1.21(0.74–2.00) 0.450
No 545 747 1292 42.2 1.00
Asthma7 Yes 11 27 38 29.0 0.66(0.36–1.20) 0.174
No 551 735 1286 42.8 1.00
Allergic Rhinitis7 Yes 27 31 58 46.6 1.11(0.75–1.62) 0.613
No 535 731 1266 42.3 1.00

1. AR = attack rate.

2. Adjusted for falla.

3. SD = Standard deviation.

4. Missing answers from 10 participants.

5. Missing answers from 7 participants.

6. Missing answers from 15 participants.

7. Missing answers from 14 participants.

Regarding age, cases were older than non-cases (36.4 ± 17.1 years versus 32.0 ± 18.0 years; p<0.001) (Table 3). When split by age groups, the highest ARs were found in the 55–64 years group (50.1%) and the 35–44 years group (47.3%), whereas the lowest ARs were observed in the 0–4 years group (25.8%) and 5–14 years group (30.5%) (Table 3), but no significant differences were observed among age groups when models were adjusted for falla.

Regarding the clinical presentation of the disease, a total of 503 cases (88.2%), including 469 confirmed cases and 34 probable cases, showed COVID-19 illness. The signs and symptoms reported by COVID-19 patients included weakness (56.3%), fever (55.1%), loss of smell and/or taste (53.8%), myalgia (51.3%), headache (46.2%) cough (49.0%), sore throat (35.7%), coryza (31.8%), diarrhea (26.6%), dermatologic lesions (12.1%), vomiting (5.7%) dyspnea (4.6%) and pneumonia (2.4%). The average disease duration was 16.1 ± 20.9 days, with a median of 7.0 days (rank 1–100). Long-term symptoms or aftermaths of COVID-19 were reported in 6.6% of cases. Of note, 247 cases (43.4%) sought medical assistance and 13 cases (2.3%) required hospitalization due to COVID-19. Only one death attributable to COVID-19 was reported during the period of the study. On the other hand, asymptomatic cases made up 12.5% of all confirmed cases (67/536), with an average age of 25.2 ± 17.6 years. No differences in the number of asymptomatic cases were found between males and females. Among total cases, 33.5% reported having a chronic disease, the most frequent of which were cardiovascular disease, hypertension, allergic rhinitis, and hypothyroidism (Table 3). No significant associations with COVID-19 incidence were found in any of the analyzed diseases. Finally, the effect of having a family member with COVID-19 at the time of disease onset was analyzed. AR among those participants who reported having a COVID-19 positive family member was 57.7% (347/601). In contrast, AR among participants who did not report a COVID-19 positive family member was 30.4% (221/727). Therefore, having a family member with COVID-19 increased the risk of COVID-19 incidence (RR = 1.91, 95% CI 1.59–2.23) (Table 3).

Analysis of COVID-19 outbreak and MGEs

General analysis of MGEs

Considering the dates of the MGEs (6 and 10 March 2020) and the temporal distribution of COVID-19 cases in the study (Fig 2), the analysis focused further on COVID-19 cases attributable to the MGEs associated with the Falles in Borriana. The 74 cases that presented the onset of symptoms or a positive test obtained before March 6 or after March 31 were therefore excluded since their illness onset (before the MGEs or more than three weeks after the last MGE) could not be related to the studied MGEs. Consequently, 1264 participants were included in the analysis with 496 cases, and AR of 39.2% (496/1264). DAGs were used to study MGEs (exposure) and COVID-19 disease (outcome) and potential confounding factors (Fig 3). Raw AR and adjusted (aAR), as well as RR and aRR, of MGEs are presented in Table 4. The aRR of males and females did not differ significantly. The aRR increased with age, from 0–4 years (aAR = 17.0%) to 35–44 years, which presented the highest values (aAR = 46.9%) (aRR = 2.77 95% CI 1.30–5.88). The age groups of 45–64 years and 65 years and above also presented high values (aAR = 44.2%) (aRR = 2.60 95% CI 1.22–5.52) and (aAR = 39.2%) (aRR = 2.31 95% CI 1.07–4.99), respectively. In addition, COVID-19 disease was associated with occupations I-II (upper and middle class) (aRR = 1.22 95% CI 1.06–1.40).

Fig 3. Directed Acyclic Graphs (DAG) of mass gathering events (exposure) effect on COVID-19 disease (outcome).

Fig 3

Ancestors of exposure and outcome (in red). Based on DAGitty version 3.0.

Table 4. Mass Gathering Event (MGE) attendance, Attack Rate (AR), adjusted AR (aAR), Relative Risk (RR), and adjusted (aRR).

Confidence interval (CI). From March 6 to 31, 2020, Borriana.

Variables Cases Non-cases AR (%) RR (95% IC) aAR1 (%) aRR (95% IC)1 p-value
Male 189 335 36.1 0.87(0.73–1.04) 39.2 0.98(0.86–1.16) 0.785
Female 307 433 41.5 1.00 39.9 1.00
Age 0–4 (years)2 6 23 20.7 1.00 17.0
5–14 49 132 27.1 1.31(0.56–3.05) 25.6 1.51(0.69–3.31) 0.305
15–24 93 159 36.7 1.77(0.78–4.05) 35.9 2.12(0.99–4.54) 0.054
25–34 64 113 36.2 1.74(0.76–4.04) 38.1 2.25(1.04–4.83) 0.039
35–44 106 127 45.5 2.20(0.97–5.00) 46.9 2.77(1.30–5.88) 0.008
45–64 161 188 46.1 2.23(0.99–5.04) 44.2 2.60(1.22–5.52) 0.013
65 and above 18 26 40.9 1.97(0.78–4.98) 39.2 2.31(1.07–4.99) 0.032
Occupation I-II1 153 166 48.0 1.30(1.08–1.58) 45.7 1.22(1.06–1.40) 0.005
Occupation III-VI 340 585 36.8 1.00 37.6 1.00
Chronic illness1 Yes 162 222 42.3 1.12(0.93–1.36) 39.7 1.01(0.88–1.17) 0.882
No 328 545 37.6 1.00 39.3 1.00
Family with COVID-19 Yes 305 254 54.6 2.01 (1.67–2.41) 51.3 1.71(1.49–1.97) <0.001
No 189 506 27.2 29.9 1.00
Body Mass Index1,3 12 31 27.9 1.00 17.5 1.00
<18.5 Kg/m2
18.5–24.9 Kg/m2 203 327 38.3 1.32(0.96–1.80) 41.5 2.37(0.96–5.85) 0.062
25.0–29.9 Kg/m2 143 177 44.7 1.57(1.13–2.17) 45.2 2.58(1.04–6.40) 0.040
≥30.0 Kg/m2 81 74 52.3 1.68(1.18–2.40) 56.3 3.21(1.29–7.98) 0.012
Physical exercise1 3 Yes 258 401 39.2 0.89(0.74–1.06) 40.1 0.88(0.77–1.01) 0.077
No 183 211 46.5 1.00 45.3 1.00
Drink alcohol 1 3 Yes 109 138 44.1 1.13(0.91–1.40) 46.9 1.14(0.99–1.32) 0.065
No 332 473 41.2 1.00 40.9 1.00
Current smoker1 3 75 197 27.6 0.66(0.51–0.85) 28.7 0.63(0.52–0.78) <0.001
Ex smoker1 3 108 100 51.9 1.25 (1.00–1.59) 50.8 1.13 (0.97–1.31) 0.122
Never smoker1 3 256 311 45.9 1.00 45.0 1.00
Pa-i-porta2 Yes 386 367 51.3 2.38(1.93–2.94) 49.9 2.15(1.80–2.56) <0.001
No 110 401 21.5 1.00 23.4 1.00
Queen’s gala dinner2 Yes 198 110 64.3 2.06(1.72–2.47) 61.9 1.90(1.67–2.17) <0.001
No 298 658 31.2 1.00 32.5 1.00
Valencia trip2 Yes 92 105 46.7 1.23(0.98–1.55) 47.9 1.25(1.06–1.46) 0.007
No 404 663 37.9 1.00 38.5 1.00
Queen’s offering2 Yes 139 74 65.3 1.92(1.58–2.34) 62.0 1.77(1.54–2.04) <0.001
No 357 694 34.0 1.00 35.0 1.00
Senior citizens’ dance2 Yes 23 8 74.2 1.93(1.27–2.94) 57.3 1.48(1.14–1.93) 0.004
No 473 760 38.4 1.00 38.8 1.00
Theater awards2 Yes 89 69 56.3 1.53(1.21–1.93) 54.1 1.44(1.22–1.70) <0.001
No 407 699 36.8 1.00 37.6 1.00
5 MGEs attended2 6 1 85.7 4.97(2.16–11.47) 77.7 4.11(3.25–5.19) <0.001
4 MGEs attended2 52 18 74.3 4.31(3.00–6.20) 75.9 4.01(3.08–5.23) <0.001
3 MGEs attended2 95 53 64.2 3.72(2.72–5.10) 61.2 3.24(2.49–4.21) <0.001
2 MGEs attended2 125 116 51.9 3.01(2.23–4.06) 49.4 2.61(2.02–3.39) <0.001
1 MGE attended2 152 263 36.6 2.13(1.59–2.84) 36.5 1.93(1.49–2.49) <0.001
0 MGEs attended2 66 317 17.2 1.00 18.9 1.00

1. Adjusted for age, sex, chronic illness, social class, family COVID-19 case, falla, and MGEs attended.

2. Adjusted for all factors except MGEs.

3. Age 15 years and above.

Those who had a family member with COVID-19 had a higher risk of SARS-CoV-2 infection (aRR = 1.71 95% CI 1.49–1.97). Additionally, the risk of contracting COVID-19 increased with higher body mass index (BMI), up to the group of 30 Kg/m2 or higher (aRR = 3.21 95% CI 1.29–7.98), and marginally with habitual alcoholic beverage consumption (aRR = 1.14 95% CI 0.99–1.32). Chronic illness and physical exercise were not associated with contracting COVID-19. On the other hand, the current smoker group presented lower risk (aRR = 0.63 95% CI 0.52–0.78). Regarding MGEs, the aAR ranged from 62.0% (the Queen’s offering) to 47.9% (the Valencia trip). The disease was associated with the pa-i-porta event with an aRR of 2.15 (95% CI 1.80–2.56), followed by the Queen’s gala dinner with aRR of 1.90 (95% CI 1.67–2.17). The other MGEs had lower aRR, but still presented a significant and considerable risk (Table 4). When MGE exposure was measured by the number of events the participants had attended, a dose-response relationship was found with raw and adjusted AR. The aAR for participants who attended no MGEs was 18.9%, increasing to 77.7% for participants who attended five MGEs (aRR = 4.11 95% CI 3.25–5.19).

Analysis of the pa-i-porta event

The analysis of the MGE with the highest number of participants, the pa-i-porta, together with different exposure variables, is shown in Table 5.

Table 5. Pa-i-porta, Mass Gathering Event (MGE) attendance, Attack Rate (AR), adjusted AR (aAR), Relative Risk (RR), and adjusted (aRR).

Confidence interval (CI). From March 6 to 31, 2020, Borriana.

Variables Cases Non- cases AR (%) RR (95% IC) aAR (%) aRR(95% IC)1 p-value
Total 386 367 51.3
Male 143 132 52.0 1.02(0.83–1.26) 49.3 0.96(0.83–1.11) 0.407
Female 243 235 50.8 1.00 51.5
Attendance time2
Less than half 32 37 46.4 1.00 44.2 1.0
Half 111 143 43.7 0.94(0.64–1.40) 44.5 1.01(0.75–1.35) 0.956
More than half 104 86 54.7 1.18(0.80–1.75) 53.6 1.21(0.91–1.62) 0.189
All the time 138 100 58.0 1.25(0.85–1.84) 58.4 1.32(0.98–1.74) 0.051
Dinner2
Ate own food 67 63 51.5 0.97(0.74–1.27) 55.5 1.07(0.88–1.29) 0.505
Ate falla food 268 238 53.0 1.00 52.0 1.00
Ate other food2
Yes 110 92 54.5 1.08(0.86–1.36) 51.0 1.00(0.85–1.18) 0.839
No 225 222 50.3 1.00 50.8 1.00
Cake consumption2
Yes 218 182 54.5 1.14 (0.99–1.43) 53.2 1.10(0.94–1.28) 0.236
No 120 132 47.6 1.00 48.7 1.00
Drank alcohol beverages at this event2 3
Yes 251 217 53.6 0.95(0.74–1.21) 54.0 0.98(0.83–1.16) 0.913
No 87 67 56.5 1.00 54.9 1.00
Attendance2
Only dance 43 58 42.6 0.81(0.59–1.11) 44.2 0.84 (0.67–1.06) 0.137
All event 332 300 52.5 1.00 52.5 1.00
Dance2
Not at all 94 93 51.3 1.00 47.6 1.00
A little 104 100 51.0 1.01(0.77–1.34) 48.5 1.04(0.84–1.29) 0.708
Some of the time 103 97 51.5 1.02(0.77–1.35) 53.2 1.12(0.91–1.38) 0.292
A lot 82 71 53.6 1.06(0.79–1.43) 56.8 1.19(0.96–1.48) 0.120
Dinner table with a COVID-19 symptomatic case4
Yes 338 311 52.4 1.18(0.86–1.62) 55.7 2.19(1.40–3.42) 0.001
No 44 56 44.0 1.00 25.5
Quadrant of building A5
Upper left 130 118 52.1 1.36 (1.01–1.84) 47.0 1.10 (0.79–1.52) 0.570
Lower left 118 113 51.1 1.32 (0.98–1.81) 51.7 1.18 (0.82–1.16) 0.309
Upper right 71 35 67.0 1.74 (1.24–2.45) 67.7 1.44 (1.12–1.85) 0.005
Lower right 63 101 38.4 1.00 40.0 1.00

1. Adjusted for age, sex, chronic illness, social class, family COVID-19 case, and falla.

2. Missing information of two cases.

3. Age 15 years and above.

4. Adjusted age, sex, mean of attendance time, and mean MGEs attended.

5. Adjusted for median of MGEs attended.

The aRR by sex was similar in females and males. Interestingly, COVID-19 disease was marginally associated with the total time attended in a dose-response relationship from less than half of the event up to the whole event (aRR = 1.32 95% CI 0.98–1.74). The food or alcoholic beverages provided by the event organizers, or those brought to the event by the participants (which included cakes or other foods) were not associated with the disease. Participants who did not participate in the dinner and only attended the dance had a lower risk, but with limited effect (aRR = 0.84 95% CI 0.67–1.16). In addition, more time spent dancing was a marginal risk factor (aRR = 1.19 95% CI 0.96–1.48). Two groups of participants were defined according to whether or not they shared a dinner table with a participant reporting onset of COVID-19 symptoms between February 26 and March 6. The exposed group presented a higher aAR of disease than those who were not exposed, 55.7% versus 25.5% (aRR = 2.19 95% CI 1.40–3.42). Finally, the location and distribution of the dinner tables in building A were analyzed. To this end, the dinner tables were classified into four quadrants and an adjusted analysis was carried out. Results showed that the upper right quadrant had a higher COVID-19 incidence than the lower right quadrant (aRR = 1.44 95% 1.12–1.85), but no difference was found with the other quadrants (Table 5).

Analysis of the Queen’s gala dinner event

The Queen’s gala dinner was the MGE with the second highest number of participants in the study (Table 6). The aRR by sex was similar in females and males. The time of attendance at this event presented a dose-response relationship from less than half attendance to whole event attendance (aRR = 1.76 95% CI 1.18–2.62). At dinner, several dishes were consumed: starters (tomato bread, pork sausages, cheese and foie gras salad and scallops), second course (sirloin), and dessert (chocolate cream). The consumption of these foods and alcoholic beverages was not associated with COVID-19 risk. Next, two groups of participants were defined according to whether or not they shared a dining table with a participant with COVID-19 disease and symptoms onset between February 27 and March 7. The exposed group showed a higher aAR than the non-exposed group (76.1% and 58.6%, respectively) (aRR = 1.30 95%1.10–1.53). The adjusted analysis of the incidence of COVID-19 cases across the four quadrants of tables in building A (same building as for the pa-i-porta event), revealed that the lower left quadrant had the highest COVID-19 incidence and differed from that of the lower right quadrant, which was the one with the lowest incidence (aRR = 1.29 95% 1.00–1.65). No differences were found with the other table quadrants (Table 6). Interestingly, the lower right quadrant was the one with the lowest COVID-19 incidence in both the pa-i-porta and the Queen’s gala dinner events.

Table 6. Queen’s gala dinner, Mass Gathering Event (MGE) attendance, Attack Rate (AR), adjusted AR (aAR), Relative Risk (RR), and adjusted (aRR).

Confidence interval (CI). From March 6 to 31, 2020, Borriana.

Variable Cases Non-cases AR (%) RR (95% IC) aAR (%) aRR(95% IC)1 p-value
Total 198 110 64.3
Male 75 44 63.0 0.97(0.72–1.29) 62.1 0.96(0.80–1.15) 0.653
Female 123 66 65.1 1.00 64.7 1.00
Attendance time
Less than half 11 13 45.8 1.00 39.8 1.00
Half 31 16 66.0 1.44 (0.78–2.88) 65.3 1.64(1.05–2.55) 0.028
More than half 42 31 57.5 1.26(0.64–2.44) 56.3 1.42(0.91–2.20) 0.121
All time 114 50 69.5 1.52(0,82.2.82) 70.2 1.76(1.18–2.62) 0.005
Dinner
Tomato bread Yes 185 101 64.7 0.94(0.51–1.73) 65.0 1.14(0.89–1.46) 0.312
No 11 5 68.8 1.00 57.1 1.00
Pork sausages Yes 182 99 64.8 0.97(0.56–1.67) 64.7 0.88(0.71–1.09) 0.249
No 14 7 66.7 73.6 1.00
Foie salad Yes 163 93 63.7 0.89(0.61–1.29) 63.9 0.82(0.68–0.97) 0.022
No 33 13 71.7 78.4 1.00
Scallops Yes 158 86 64.8 0.99(0.69–1.41) 65.3 0.96(0.79–1.17) 0.673
No 38 20 63.8 68.1 1.00
Sirloin Yes 173 96 64.3 0.92(0.60–1.43) 65.0 0.77(0.67–0.89) <0.001
No 23 10 69.7 1.00 84.4 1.00
Chocolate Yes 165 82 66.8 1.19(0.81–1.74) 67.5 1.13(0.91–1.40) 0.263
No 31 24 54.5 59.8 1.00
Drank alcohol 2 Yes 163 94 63.4 0.93(0.65–1.35) 63.6 1.20(0.95–1.52) 0.123
No 34 14 70.8 52.8 1.00
Dinner table with a COVID-19 symptomatic case3
Yes 88 35 71.5 1.18(0.89–1.57) 76.1 1.30(1.10–1.53) 0.002
No 103 67 60.6 1.00 58.6 1.00
Quadrant of building A4
Upper left 44 18 71.0 1.27 (0.84–1.91) 63.4 0.98(0.72–1.34) 0.917
Lower left 43 15 74.1 1.33 (0.88–2.00) 83.0 1.29(1.00–1.65) 0.047
Upper right 57 32 64.0 1.44 (0.78–1.68) 64.6 1.00(0.76–1.32) 0.990
Lower right 47 37 56.0 1.00 64.4 1.00

1. Adjusted for age, sex, chronic illness, social class, family COVID-19 case, and falla.

2. Age 15 years and above.

3. Adjusted for age, sex, chronic illness, social class, family COVID-19 case, falla, attendance time, quadrant, and number of MGEs attended.

4. Adjusted for age, sex, chronic illness, social class, family COVID-19 case, falla, symptomatic case in dinner table, and number of MGEs attended.

Finally, our analysis also found that four out of the five food handlers who served in the two MGE dinners were confirmed COVID-19 cases by laboratory tests. Three of them reported having COVID-19 symptomatology starting on March 16, 17, and 24 March 2020, respectively, after the MGEs were over. One case was asymptomatic.

Sensitivity analysis

The sensitivity analysis included the 1064 participants with laboratory tests of COVID-19 and cases between 6 and 31 March 2020 (Tables 7 and 8). The AR of this group was 44.0% from 468 COVID-19 cases and 596 non-cases. Some variations with the previous findings were found, considering its lower sample size and the higher age of participants (Table 2). Risk factors such as age and BMI lost significance, but alcohol consumption was associated with COVID-19 disease. Other factors did not show considerable changes. The pa-i-porta and the Queen’s gala dinner maintained significant associations with COVID-19, including attendance time, table shared with a COVID-19 symptomatic participant, and quadrants in building A. In the Queen’s gala dinner, quadrants lost significance.

Table 7. Sensitivity analysis.

Participants with laboratory tests of SARS-CoV-2 and mass gathering event (MGEs) attendance, attack rate (AR) adjusted AR (aAR), and adjusted (aRR). Confidence interval (CI). From March 6 to 31, 2020, Borriana.

Variables Cases Non-cases AR (%) aAR (%) aRR (95% IC)1 p-value
Male 180 249 42.0 44.1 1.01(0.89–1.16) 0.862
Female 288 347 45.4 43.6 1.00
Age 0–4 (years)2 4 14 22.2 16.4 1.00
5–14 44 84 34.4 29.4 1.79(0.50–6.38) 0.370
15–24 88 115 43.4 42.1 2.46(0.69–9.00) 0.143
25–34 60 90 40.0 42.3 2.58(0.73–9.08) 0.142
35–44 100 105 48.8 49.9 3.03(0.87–10.63) 0.083
45–64 155 167 48.1 46.7 2.84(0.81–9.94) 0.102
65 and above 17 21 44.7 41.1 2.50(0.71–8.83) 0.154
Occupation I-II1 142 122 53.8 51.6 1.23(1.07–1.42) 0.003
Occupation III-VI 323 469 40.8 41.9 1.00
Chronic illness1 Yes 155 184 42.9 43.7 0.99(0.87–1.15) 0.992
No 309 411 45.7 43.9 1.00
Family with COVID-19 Yes 293 213 57.9 55.6 1.64(1.43–1.88) <0.001
No 174 376 31.6 33.9 1.00
Body Mass Index1,3 <18.5 Kg/m2 11 24 31.4 6.7 1.00
18.5–24.9 Kg/m2 189 252 42.9 45.6 6.81(0.41–113.91) 0.182
25.0–29.9 Kg/m2 139 154 47.4 48.8 7.29(0.44–121.98) 0.167
≥30.0 Kg/m2 79 66 54.5 59.1 8.83(0.53–401.56) 0.130
Physical exercise1,3 Yes 244 322 43.1 44.1 0.90(0.78–1.02) 0.109
No 176 176 50.0 49.2 1.00
Drank alcohol 1,3 Yes 104 108 49.1 53.4 1.19(1.04–1.37) 0.015
No 316 390 44.8 44.8 1.00
Current smoker1,3 68 169 28.7 30.7 0.62(0.50–0.75) <0.001
Ex smoker1,3 104 83 55.6 54.8 1.10 (0.95–1.28) 0.215
Never smoker1,3 246 245 50.1 49.8 1.00
5 MGEs attended2 6 1 85.7 82.6 3.62(2.83–4.61) <0.001
4 MGEs attended2 52 15 77.6 78.7 3.44(2.63–4.49) <0.001
3 MGEs attended2 94 48 66.2 64.3 2.81(2.15–3.67) <0.001
2 MGEs attended2 121 101 54.5 53.0 2.32(1.78–3.02) <0.001
1 MGE attended2 139 224 38.3 37.9 1.66(1.27–2.16) <0.001
0 MGEs attended2 56 207 21.3 22.9 1.00

1. Adjusted for age, sex, chronic illness, social class, family COVID-19 case, falla, and MGEs attended.

2. Adjusted for all factors except MGEs.

3. Age 15 years and above.

Table 8. Sensitivity analysis.

Participants with laboratory tests of SARS-CoV-2 and the pa-i-porta and Queen’s gala dinner mass gathering event (MGE) attendance, attack rate (AR), adjusted AR (aAR), and adjusted (aRR). Confidence interval (CI). From March 6 to 31, 2020, Borriana.

Variables Cases Non-cases AR (%) aAR (%) aRR (95%IC)1 p-value
Pa-i-porta
Attendance1 Yes 371 316 54.0 53.0 1.96(1.64–2.35) <0.001
No 97 280 25.7 27.0 1.00
Attendance time1 2
Less than half 30 33 47.6 44.6 1.00
Half 102 119 46.2 45.6 1.02(0.75–1.38) 0.887
More than half 102 74 58.0 52.3 1.26(0.94–1.70) 0.122
All the time 136 89 60.4 61.2 1.37(1.03–1.83) 0.031
Dinner table with a COVID-19 symptomatic case3
Yes 326 263 55.3 58.8 2.57(1.45–4.83) 0.001
No 41 46 47.1 22.9 1.00
Quadrants building A4
Upper left 127 93 57.7 51.8 1.25(0.88–1.77) 0.212
Lower left 112 98 53.3 53.3 1.29(0.95–1.74) 0.105
Upper right 69 31 69.0 69.3 1.67(1.34–2.08) 0.000
Lower right 59 87 40.4 41.5 1.00
Queen’s gala dinner
Attendance1 Yes 196 98 66.7 65.5 1.80(1.58–2.05) <0.001
No 272 498 35.3 36.4 1.00
Attendance time1
Less than half 11 11 50.0 42.4 1.00
Half 31 14 68.9 69.9 1.65(1.08–2.51) 0.019
More than half 42 26 61.8 61.0 1.44(0.94–2.18) 0.086
All the time 112 47 70.4 71.0 1.67 (1.15–2.45) 0.008
Dinner table with a COVID-19 symptomatic case5
Yes 88 31 74.0 74.7 1.19 (1.01–1.40) 0.037
No 101 61 62.4 62.8 1.00
Quadrant of building A6
Upper left 43 18 70.5 66.9 1.01(0.73–1.35) 0.971
Lower left 43 14 75.4 84.9 1.26(0.98–1.63) 0.075
Upper right 56 26 68.3 63.8 0.95(0.71–1.27) 0.718
Lower right 47 34 58.0 67.2 1.00

1. Adjusted for age, sex, chronic illness, social class, family COVID-19 case, and falla.

2. Missing information in two cases.

3. Adjusted age, sex, median of attendance time, and median MGEs attended.

4. Adjusted for median of MGEs attended.

5. Adjusted for age, sex, chronic illness, social class, family COVID-19 case, falla, attendance time, quadrant, and number of MGEs attended.

6. Adjusted for age, sex, chronic illness, social class, family COVID-19 case, falla, symptomatic case in dinner table, and number of MGEs attended.

Discussion

The results of this study indicate a high transmission of COVID-19 disease in the MGEs studied, which may be considered as a community outbreak with several point sources from March 6 to 10 [47]. Respiratory transmission was the predominant mode of propagation by droplets from patients to exposed persons; contact via fomites was less frequent [48, 49]. Airborne transmission has been suggested in relation to COVID-19 outbreaks in different places, and is a plausible route [5052]. The two MGEs with the highest incidence of the disease included a dinner, as in other COVID-19 outbreaks, but food-borne transmission can be discarded in this study [53, 54].

Some characteristics of this MEG outbreak may be highlighted, including its magnitude and impact in the population of Borriana, the diversity of places where it occurred indoors (building and theater) and outdoors (square), the higher risk of COVID-19 associated with the number of MGEs attended, the estimation of risk for attendance at no MGEs, the detection of risk factors (obesity, old age, and upper and middle class versus lower class) with current smoking as a protective factor, and the rapid spread with high ARs.

In the study, the AR was 42.6%, and during the period of the MGEs, 39.2% with 94.0% of confirmed cases. If the AR were extrapolated to falles members, the total of COVID-19 cases could be between 1193 (95% CI 1269–1117) and 1098 (95% CI 1173–1023), respectively. In addition, a high proportion of cases had family members with COVID-19, suggesting a high secondary transmission among families, in line with Thompson and co-authors and with a study of secondary attack rate of COVID-19 infections in Castellon [55, 56]. It may explain the high incidence in the municipality of Borriana, which was the highest in the province of Castellon during the first outbreak period. Considering the period February to July 2020, the incidence of COVID-19 in Borriana was 307 cases with positive PCR results (885 per 100,000 inhabitants) and 40 deaths (1.2 per 1000 inhabitants) [34]. As a comparison, the COVID-19 incidence in Castellon de la Plana, the provincial capital (170,000 inhabitants), was 463 cases (272.4 per 100,000 inhabitants) and 50 deaths (0.29 per 1,000 inhabitants). The high mortality in Borriana is striking [57, 58], and it may be related to the prevalence of cardiovascular risk factors in this municipality [59]. Regarding the incidence of COVID-19, the study found 536 confirmed cases, 39 cases with positive PCR results; these were the only cases reported by the health authorities. It may be estimated that for every reported case, there could have been around 13 or 14 cases, implying that 92.7% of cases were undiagnosed. This situation is in line with two studies on undocumented infections of SARS-CoV-2 in China (86% and 93%), and France (86%), respectively [6062].

In the context of COVID-19 outbreaks related to MGEs, different models have been proposed to estimate the number of cases deriving from MGEs or Ro values [63, 64]. Apart from assuming several premises, these models need a constant infection rate or Ro. As a tentative approximation and using the classic SIR (susceptible, infected, recovered) infection process model [65], we explored our results to obtain the Ro from the infection rate based on the date of onset of cases, number of contacts, and duration of infectiousness. We used the formula [66]:

Ro=PIxCRxDI

where PI = “average probability a contact will be infected over duration of a relationship”; CR = “average rate of getting into contact”; and DI = “average duration infectiousness”. We defined PI, the infection rate, as new cases of COVID-19 divided by the susceptible participants per day; CR as a number of potential contacts, following the study of Tupper and co-authors [63], and DI as 10 days duration of infectiousness [67]. We considered a period of 19 days from the first MGE to the last MGE, plus a 14-day maximum incubation period for COVID-19. The results are shown in Table 9.

Table 9. Estimation of the basic reproductive number (Ro) from the MGE COVID-19 outbreak between 6 and 10 March 2020 plus 14 days.

Days/Date infection onset New cases (a) Total cases (I) (b) Susceptible (S) (c) Infection rate (a/c) Basic reproduction number Ro1 Numbers of contacts2
5 10 15
3/6/2020: 03 9 9 1264 0.00712 0.36 0.71 1.07
3/7/2020: 13 11 20 1255 0.00877 0.44 0.88 1.32
3/8/2020: 23 15 35 1244 0.01206 0.60 1.21 1.81
3/9/2020: 3 45 80 1229 0.03662 1.83 3.66 5.49
3/10/20203 4 39 119 1184 0.03294 1.65 3.29 4.94
3/11/2020: 5 32 151 1145 0.02795 1.40 2.80 4.19
3/12/2020: 6 21 172 1113 0.01887 0.94 1.89 2.83
3/13/2020: 7 31 203 1092 0.02839 1.42 1.84 4.26
3/14/2020: 8 33 236 1061 0.03110 1.56 3.11 4.67
3/15/2020: 9 30 266 1028 0.02918 1.46 2.92 4.38
3/16/2020:10 48 314 998 0.04810 2.41 4.81 7.22
3/17/2020:11 20 334 950 0.02105 1.03 2.05 3.08
3/18/2020:12 18 352 930 0.01935 0.97 1.94 2.90
3/19/2020:13 15 369 912 0.01644 0.82 1,64 2.47
3/20/2020:14 15 382 897 0.01672 0.84 1.67 2.51
3/21/2020:15 6 388 882 0.00680 0.34 0.68 1.02
3/22/2020:16 7 395 876 0.00799 0.40 0.80 1.20
3/23/2020:17 2 397 869 0.00230 0.12 0.23 0.35
3/24/2020:18 4 401 867 0.00461 0.23 0.46 0.69
3/25/2020:19 7 408 863 0.00811 0.41 0.81 1.22

1. Ro = infection rate x contact numbers x duration infectiousness (10 days).

2. Considering average numbers of contacts in conferences, lectures, and restaurants (5, 10, and 15).

3. Date with MGE.

Considering the infection rate per day, an increase was observed from 0.00172 on the first day to 0.04810 on March 16 and a decline until 0.00811 on March 25. The countrywide lockdown began on March 15 and has been shown to have had a high effect [68]. With five contacts, Ro>1.0 reached only 8 days and a maximum of 2.41; with 10 contacts, Ro>1.0 reached 13 days and a maximum of 4.81; and with 15 contacts, Ro>1.0 reached 19 days and a maximum of 7.22 on the 16th day. The decline of the Ro was very steep from the maximum and Ro<1.0 values were observed, indicating that the epidemic would soon decline [69]. These results reflect the high transmission of the disease associated with MGEs.

To explore the expected numbers of cases in the COVID-19 outbreak associated with the MGEs, we followed the approach of Tupper and co-authors [63], considering the probability of infection (β), the duration time (T), time of contact (τ) and the number of contacts (k). We calculated k from two MGEs (pa-i-porta and the Queen’s gala dinner). The formula yields the expected number of new infections:

Revent=(kT/τ)(1eβτ)

Attendances at the pa-i-porta and Queen’s gala dinner events were used to estimate expected cases and compare them with observed cases. For the pa-i-porta event, the number of contacts was 85 for less than half the attendance time and 60 for more than half the attendance time, to obtain a similar number of observed and expected cases. For the Queen’s gala dinner the numbers of contacts were 20 for less than half the attendance time and 40 for more than half the attendance time. Considering that 9 and 11 cases of COVID-19 (Table 10) had the onset of symptoms the day of the pa-i-porta and the Queen’s gala dinner, respectively, the number of contacts k could be divided by 9 and 11, and contacts could be 7 to 10 for pa-i-porta and 2 to 4 for the Queen’s gala dinner. These results could explain the spread of the epidemic, and underline the importance of the duration of the event, the number of contacts, and the number of participants, which were much higher in the pa-i-porta than in the Queen’s gala dinner. However, a major limitation of this approach is the theoretical assumption of homogeneous mixing of population in the epidemic [70]. In addition, asymptomatic or undiagnosed cases may bias the results and 67 cases were asymptomatic in our study.

Table 10. Attendance at pa-i-porta and Queen’s gala dinner MGEs and number of contacts (k) to obtain expected cases of COVID-19 compared with observed cases from the formula of Tupper and co-authors [63].

MGEs Attendance time Probability infection β Time T hours Contact time τ Number contacts k Number expected Cases Number observed cases
Pa-i-porta Less than half 0.465 3.30 0.2 85 132.1 132
More than half 0.594 7.0 0.2 60 235.2 238
Queen’s gala dinner Less than half 0.627 3.15 0.2 20 41.2 42
More than half 0.678 6.30 0.2 40 152.2 154

1. Infection rates of attendance at pa-i-porta and Queen’s gala dinner

2. Contact time from Tupper and co-authors [63].

In our study the iceberg-like pattern of COVID-19 could be observed, considering the percentages of 0.17% patient deaths, 2.3% hospitalized, 12% asymptomatic, and 85.8% symptomatic [71]. The most frequent symptoms of COVID-19 cases were weakness, fever, and lost smell or/and taste; the severe course of the disease was less frequent in accordance with the average age of the patients [59, 72, 73]. In addition, the medical assistance was low and chronic illness was weakly associated with COVID-19, but cardiovascular diseases, hypertension, and hypothyroidism increased the risk of COVID-19, as indicated in some studies [74, 75]. The presence of sequels remains low, but this is a new disease and follow-up of these patients would be useful.

Considering the risk factors of COVID-19, higher age was associated with the disease, and children and adolescents were less affected [76, 77]; in contrast with other studies [78], sex was not a risk factor. Young patients constituted asymptomatic cases, and their frequency was lower than in other studies [7981]. The validity of self-reported lifestyle data has been considered good [82], and overweight and obesity were risk factors in line with population-based studies of COVID-19 [83, 84]. In addition, Merzon and co-authors [85] found that vitamin D deficiency was a risk factor of COVID-19 infection and severity. Alcohol consumption was a marginal risk factor, but has not been found in some studies [86, 87]. Upper and middle social classes were associated with the disease, in contrast with other studies [85, 88]. Smoking is a controversial factor because it has been found to be both protective and a risk factor [8587, 89, 90].

When observing the MGEs, it may be useful to consider that participation in the Falles festival was extensive, since the population of Borriana, both adults and children, took part in many cultural, touristic, leisure, and dinner events [35], and many MGEs were held in February and March 2020. These MGEs may be considered as super-spreading events [91, 92]. In this context, several points stand out. First, COVID-19 cases began in January and February 2020, with the onset of symptoms before the MGEs took place. Second, the pa-i-porta and the Queen’s gala dinner included dancing, which involved more contact among participants. In these MGEs the presence of participants with symptoms at the same dinner table was a significant risk factor of COVID-19, which is consistent with symptomatic cases being more contagious than asymptomatic cases [10, 93, 94]. Third, indoor MGEs had a high attendance, mainly in building A; considering the building’s capacity and the close proximity among participants, a higher risk of transmission was found [3, 95, 96]. Attendance at the other MGEs was lower and full capacity was not reached. Fourth, several MGEs lasted for more than six hours and ended in the early morning. The average temperature in Borriana in March is 13.4°C, and the average relative humidity is 64% [97]. These weather conditions have been shown to favor SARS-CoV-2 transmission, estimated to range between 5°-15°C and 30–100% of temperature and relative humidity, respectively [98, 99]. Fifth, all the MGEs except the Valencia trip occurred in closed indoor places, building A and theater B; both locations have air conditioning and heating, which are more modern in the case of theater B, and no breakdowns or malfunctions were observed. Finally, airborne transmission [100] may be possible, and our results indicate one quadrant of building A with a lower incidence of COVID-19, but the two quadrants with the highest incidence were not the same in the two events, and these two quadrants were occupied by the Falles organizers and guests, who had attended the most MGEs. However, the presence of asymptomatic cases, the variability of the incubation period, and other potential transmission sources make it difficult to confirm this transmission in these MGEs.

A potential causal relationship between MGE attendance and COVID-19 may be considered following the Austin Bradford-Hill criteria [101]; aRR of MGE attendance ranged from moderate to high. It has been suggested that there is a biological plausibility of COVID-19 transmission happening in closed places, where many participants gather in areas that are smaller than 1.83 m2 per individual [102]. This is consistent with other COVID-19 outbreaks in MGEs in several countries [21, 24, 42, 103, 104]. The temporal relationship between MGE attendance and COVID-19 was established after the event. A dose-response relationship was demonstrated between MGE attendance, attendance time, and risk of the disease [105]. As an observational study, a retrospective cohort design could estimate the causality relationship more precisely than descriptive studies.

The strengths of our study are as follows. First, it has a population-based design that allows a more integral approach to COVID-19. Second, a representative sample of a population exposed to MGEs was analyzed. Third, the response rate was high. Fourth, a serologic survey was carried out to confirm COVID-19 cases [106, 107] with a highly sensitive and specific technique. Fifth, statistical analysis was adjusted for potential confounding factors. Finally, the sensitivity analysis confirmed the previous results with an improvement in study precision.

The study’s limitations are as follows. First, there was a period of time between exposure at the MGEs and the start of the study. In addition, the impact of the COVID-19 pandemic could have caused some recall and misclassification biases. Second, only the Falles population was included in the study. Third, other MGEs were not studied, such as the Ninot parade, community dinners, children’s entertainments, and others that may have played a role in COVID-19 transmission in Borriana. Fourth, an estimation of incubation periods was difficult considering the variety of MGE attendance. Fifth, no genetic studies were carried out into the SARS-CoV-2 of positive PCR patients. Sixth, some residual biases may persist despite adjustments. Finally, as a new disease, COVID-19 could have some factors that were not considered in the study.

Some recommendations may be addressed based on the results of the study. First, and with immediate effect, MGEs should be considered as potential triggers of high transmission of SARS-CoV-2. The maintenance, conservation, and inspection of the closed indoor building where these MGEs took place should also be strengthened. We must highlight that MEGs have continued to be held successfully with measures in place to prevent SARS-CoV-2 transmission, suggesting that MGEs could be implemented again with specific prevention measures [108112]. Second, COVID-19 patients should be monitored to find out about this new disease and its evolution. Third, population-based studies, including serologic surveys, should be carried out to estimate the extent of COVID-19 [113, 114]. Finally, regarding our study, new lines of research could be implemented, including estimating other risk factors of COVID-19 disease, determining serologic variations of antibodies against SARS-CoV-2 in the coming months, following-up patients and potential sequels, and exploring factors associated with the spread of the COVID-19 pandemic [115].

As an epilogue to our study, we are carrying out a prospective cohort study with patients who tested positive for COVID-19, and a second sero-epidemiological study, started in October 2020, to research evolution, sequelae and antibodies against SARS-CoV-2.

Conclusions

The results of this study suggest the importance of MGEs in COVID-19 transmission that could explain the subsequent COVID-19 outbreak in Borriana. Population-based studies, including serologic COVID-19 surveys, may usefully inform the adoption of preventive measures that help to contain the COVID-19 pandemic.

Supporting information

S1 File

(DOCX)

S1 Data

(DTA)

S2 Data

(DTA)

S1 Dataset

(DOCX)

Acknowledgments

We are grateful to all the people who participated in the study and to the organizers of the Falles in Borriana for their help and support. In addition, we wish to thank Roser Blasco-Gari, Helena Buj-Jorda, Israel Borras-Acosta, Lucia Castell-Agusti, Mercedes De Francia-Valero, Maria Domènech-Molinos, Marc Garcia, Maria Gil-Fortuño, Elena Grañana-Toran, Noelia Hernández-Perez, Laura Lopez-Diago, Salvador Martinez-Parra, Sara Moner-Marin, Silvia Pesudo-Calatayud, Lara Sabater-Hernández, Maria Luisa Salve-Martinez, Irene Suarez-Linares, Juan José Ventura-Buchardo, and Alberto Yagüe-Muñoz for their assistance and support in carrying out the study. We acknowledge the help of Francis Conde-Mollà, Cristina Devis-Drago, and Carolina Vicente-Rodriguez in implementing this study, Jose Monserrat-Vicent for his assistance with the English and Mary B Savage Cooper for her English revision. We thank Claudia Arnedo-Pac and Jose Antonio Valer for their advice and for constructing the figures.

Data Availability

All relevant data are within the manuscript and its Supporting Information files.

Funding Statement

The author(s) received no specific funding for this work.

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Decision Letter 0

Huseyin Cakal

Transfer Alert

This paper was transferred from another journal. As a result, its full editorial history (including decision letters, peer reviews and author responses) may not be present.

8 Apr 2021

PONE-D-21-04796

“MASS GATHERING EVENTS AND COVID-19 TRANSMISSION IN BORRIANA (SPAIN): A RETROSPECTIVE COHORT STUDY.”

PLOS ONE

Dear Dr. Arnedo-Pena

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

I have read the comments provided by two expert reviewers and I read the mansucript myself too. I will not reiterate the Rs comments but I will add mine. I strongly recommend consulting PlosOne styling guide for submissions. At the moment, the ms looks like a draft: arbitary spaces, no line numbers, tables included in the main text, some of the tables are tilted, e.g. Table 7; as well as overal language. As Rs mention, there is merit in this study but it needs to substantial amount work on style.

Please submit your revised manuscript by May 23 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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PLOS ONE

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Reviewers' comments:

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Comments to the Author

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Reviewer #1: Yes

Reviewer #2: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: N/A

**********

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Reviewer #1: Yes

Reviewer #2: No

**********

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Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

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Reviewer #1: The manuscript entitled “MASS GATHERING EVENTS AND COVID-19 TRANSMISSION IN BORRIANA

(SPAIN): A RETROSPECTIVE COHORT STUDY” aims at estimating the incidence of COVID-19 disease, its association with MGEs and quantifying the potential risk factors of its occurrence.

The manuscript is interesting, nevertheless, it presents some flaws which make me conclude that before it is ready for publication in PLOS ONE the authors need to address some minor issues. Below are my comments to the authors and I hope these ideas will be helpful to them for improving their manuscript.

Abstract

The abstract seems clear, although I would recommend describing in more details the purpose of the study and the aims that are to be achieved. Additionally, it is important to highlight the novelty of the study.

Introduction

Although very short the introduction is also mostly clear and well written. However, I have some suggestions or inquire to clarify some minor issues:

1. The Introduction should present the literature to date and identify a gap in this research area, therefore I´m sure it would benefit from editing some of the content. Please, at least mention the definition of mass gatherings and some of its characteristics.

2. In the same vain, for instance, if the existing empirical evidence regarding the effects of mass gatherings provide ambiguous results, please explain what is unclear and why.

Method

The method section in exhaustive and well explained.

3. Would be helpful to have some more details regarding how the participants were recruited.

4.What other variables was used in the project, only those presented in the paper?

Results

The result section is well described and explained.

Discussion

5. Although the findings are interesting, and they do confirm the hypothesis I am not exactly sure how the current paper adds to what we already know. Therefore, it would be nice to introduce a short paragraph, which resumes the unique contributions of the study.

8. The writing is sometimes problematic and hard to understand and the flow a bit choppy. Therefore, I would recommend a thorough spell and grammar check of the entire paper.

12. In general, I think especially the discussion currently does not do a good job at all in highlighting the unique contributions of the paper.

Reviewer #2: The present research is devoted to analyze how mass gathering events linked to the “Falles” festival in Borriana are related to COVID-19 incidence, while also examining a number of relevant risk factors. The results highlight the importance of these mass gathering events in explaining COVID-19 incidence.

Although the article stated in the discussion section that studies estimating COVID-19 risk factors are limited, a broad range of them can be observed in the literature.

Overall, limitations of this research relate to the lack of a solid structure in the introduction section. This section only makes a brief reference to the general aim of this research.

Clear theoretical foundations and literature review closely related to topic under study are needed.

Description of MGEs during “Falles” festival in Borriana should be covered in further detail (as a complement, the creation of a summary table might be considered).

It is stated that the study was conducted from 14th May to 31st, June 2020, and that it comprises two phases. However, later on is mentioned that the fir phase started on April. In addition, at the same page it is stated that the study period ranged from January to June 2020. A more detailed, comprehensible, and homogenous description of the study’s design should be provided.

2.3% of participants were between the age range 0-4, and 14.2% between 5 and 14 (under legal minimum age in Spain). Could these participants adequately fill out the questionnaire survey? What procedure was followed? How certain sociodemographic variables (e.g., social class) were calculated on the basis of the abovementioned fact?

These aspects must be addressed as there is a considerable number of participants under 5 and 14 years old, thereby reflecting the need to provide more detailed description on procedure and methodological aspects.

Did the authors collect participants’ educational level? It should have been included as a control variable in the light of its connections with COVID-19 social behavior.

The inclusion of each potential risk factor (confounding factors) should be previously explained/justified.

The section Analysis of COVID-19 outbreak and MGEs should be divided in to “smaller” sections so as to facilitate a clear picture of the current results.

The discussion section should be addressed considering prior comments.

Certain grammatical and reading errors are still observed. This version must be proofread and edited by a native English-speaking expert.

**********

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Anna Wlodarczyk

Reviewer #2: No

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PLoS One. 2021 Aug 26;16(8):e0256747. doi: 10.1371/journal.pone.0256747.r002

Author response to Decision Letter 0


11 May 2021

Response to the Editor and Reviewers

PONE-D-21-04796

“MASS GATHERING EVENTS AND COVID-19 TRANSMISSION IN BORRIANA (SPAIN): A RETROSPECTIVE COHORT STUDY.”

PLOS ONE

Dear Mr. Huseyin Cakal

Thank you very much for your attention and help.

We have tried to follow all your indications and suggestions.

Journal Requirements:

1. The PLOS ONE style.

We have to try to follow the recommended PLOS OPEN style.

2. Please correct your reference to “p=0.000” to “p<0.001”

We have corrected the p values p=0.000 to p<0.001

3. Please provide additional details regarding participant consent.

We obtained a verbal consent of the participants before to perform the survey questionnaire. Several clarifications have made during the phone call as stated in the questionnaire.

-The participation in this study is voluntary, and in at any time you can leave the study, without damage on your part.

-You can receive information about the study.

-The personal information obtained from this study for the identification of each patient will be kept in the strictest confidentiality.

-The data collected will be used anonymously for scientific research, safeguarding your privacy.

Explicit consent:

-Given the characteristics of the study and that the survey is carried out by telephone, it is understood that in addition to answering affirmatively to the question if you want to participate, the fact of answering the questionnaire ratifies said consent.

-So that the research is carried out with scrupulous respect for ethical principles and there is no doubt about the voluntary participation, the researcher responsible for data collection is identified.

4. Please state in your methods section whether you obtained consent from parents of guardians of the minors.

When a child was chosen in the sampling, their parents were asked if they allowed their child to participate and answer the questionnaire with the help of the parents, considering the all clarifications before to perform the survey questionnaire.

5. Please include additional information regarding the survey or questionnaire used in the study.

A copy of the questionnaire sample and its English translation are included in the supporting information.

6. All PLOS journals require that the minimal data set be made fully available. Moreover, please include more details on how the questionnaire was pre-tested, and whether it was validated.

We add the Dataset of the study: the principal Dataset: borriana6661.dta and an additional Dataset:pa-i-porta6661.dta. The STATA® 14 version program was used.

Our questionnaire was not validated before. However, we used a questionnaire to study the secondary attack rate of COVID-19 infection in household contacts of Castellon, and the approach (telephone interview) and some questions were similar. The reference is

Arnedo-Pena A, Sabater-Vidal S, Meseguer-Ferrer N, Pac-Sa R, Mañes-Flor P, Gascó-Laborda JC, et al. COVID-19 secondary attack rate and risk factors in household contacts in Castellon (Spain): Preliminary report. Rev Enf Emer 2020;19:64-70.

Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as a

Reviewer #1: The manuscript entitled “MASS GATHERING EVENTS AND COVID-19 TRANSMISSION IN BORRIANA

(SPAIN):

Thank you very much for your indications and suggestions. We appreciate your positive attitude.

-The abstract seems clear, although I would recommend describing in more details the purpose of the study and the aims that are to be achieved. Additionally, it is important to highlight the novelty of the study.

We clarify the objective of the study.

1. The Introduction should present the literature to date and identify a gap in this research area, therefore I´m sure it would benefit from editing some of the content. Please, at least mention the definition of mass gatherings and some of its characteristics.

We have changed the introduction with more than 20 new references. We add the definition MGEs by the WHO, characteristics of MGEs, and several MGEs with COVID-19 transmission in different countries. References of control of MGEs by WHO and CDC are indicated and the basic reproductive number (Ro). . Some problems in the reporting of COVID-19 outbreaks and COVID-19 outbreaks in Spain are included in the introduction (lines 92-111).

2. In the same vain, for instance, if the existing empirical evidence regarding the effects of mass gatherings provide ambiguous results, please explain what is unclear and why.

Some biases in COVID-19 outbreak epidemiologic studies have been indicated, and we add references of this aspect (lines 112-116).

3. Would be helpful to have some more details regarding how the participants were recruited.

We explain in more detail how the participants were recruited means a numbered list of the members of each falla and the list of participants in the Queen gala dinner (lines 195-198).

4. What other variables was used in the project, only those presented in the paper?

In order to try to test our hypothesis of the high incidence of COVID-19 disease, a longer questionnaire was used. Some variables like taking vitamins or medications, frequency of activities and sleeping during March 6-10, amount of food consumed during MGEs dinners, and means to travel to Valencia were not included in the paper.

Discussion

5. Although the findings are interesting, and they do confirm the hypothesis I am not exactly sure how the current paper adds to what we already know. Therefore, it would be nice to introduce a short paragraph, which resumes the unique contributions of the study.

We add a paragraph to the summary of the study findings (lines 564-570).

8. The writing is sometimes problematic and hard to understand and the flow a bit choppy. Therefore, I would recommend a thorough spell and grammar check of the entire paper.

The final version of the manuscript has been reviewed by a native English-speaking professor.

12. In general, I think especially the discussion currently does not do a good job at all in highlighting the unique contributions of the paper.

We have made several changes in the discussion with new paragraph to summarize the findings of the study. In addition, we add two tables in order to apply the Ro to our data (lines 591-647).

Table 9. Estimation of the basic reproductive number (Ro) from the MGE COVID-19 outbreak between 6 and 10 March 2020 plus 14 days

Table 10. Attendance at pa-i-porta and Queen’s gala dinner MGEs and number of contacts (k) to obtain expected cases of COVID-19 compared with observed cases from the formula of Tupper and co-authors (63).

We have included new references of MEGs, how the MEGs are taking place now, and an epilog of our study: a cohort study of COVID-19 patients (lines 737-740).

Reviewer #2: The present research is devoted to analyze how mass gathering events linked to the “Falles” festival in Borriana are related to COVID-19 incidence, while also examining a number of relevant risk factors. The results highlight the importance of these mass gathering events in explaining COVID-19 incidence.

Thank you very much for your indications and suggestions

Although the article stated in the discussion section that studies estimating COVID-19 risk factors are limited, a broad range of them can be observed in the literature. Overall, limitations of this research relate to the lack of a solid structure in the introduction section. This section only makes a brief reference to the general aim of this research. Clear theoretical foundations and literature review closely related to topic under study are needed.

We have improved the introduction section and have added a definition of MGEs from the WHO with MGEs studies of different countries, and have explained some limitations in the MGEs study such as the small size, few adjusted risks for confounders, and basic statistical analysis. In addition, we add references of COVID-19 outbreaks in Spain (lines 90-120).

Description of MGEs during “Falles” festival in Borriana should be covered in further detail (as a complement, the creation of a summary table might be considered).

We explain one by one the all MGEs and add a table with all these MGEs (lines 164-165) and Table 1.

Table 1. Characteristics of mass gathering events (MGEs) connected to the Falles festival in Borriana from March 6 to 10.

It is stated that the study was conducted from 14th May to 31st, June 2020, and that it comprises two phases. However, later on is mentioned that the fir phase started on April. In addition, at the same page it is stated that the study period ranged from January to June 2020. A more detailed, comprehensible, and homogenous description of the study’s design should be provided.

We have been corrected these dates and the period of COVID-19 cases occurred have been indicated, January-June 2020 (lines 167,175, and 180).

2.3% of participants were between the age range 0-4, and 14.2% between 5 and 14 (under legal minimum age in Spain). Could these participants adequately fill out the questionnaire survey? What procedure was followed?

When a child was chosen in the sampling, their parents were asked if they allowed their child to participate and answer the questionnaire with the help of the parents, considering the all clarifications before to perform the survey questionnaire. This is indicated in the text (lines 180-186).

How certain sociodemographic variables (e.g., social class) were calculated on the basis of the abovementioned fact?

The occupations of parents were asked in the questionnaire and the social class was estimated in two groups: Group I and II; professional, managerial and technical occupations; Group III-VI: skilled, non-manual or manual; partly-skilled; unskilled occupations. Children had the same social class of their parents (lines186-188).

These aspects must be addressed as there is a considerable number of participants under 5 and 14 years old, thereby reflecting the need to provide more detailed description on procedure and methodological aspects.

We explain this aspect in the manuscript (lines 258-269).

Did the authors collect participants’ educational level? It should have been included as a control variable in the light of its connections with COVID-19 social behavior.

We did not collect education level, we ask about occupation. In addition, the outbreak took place before the COVID-19 transmission was well known.

The inclusion of each potential risk factor (confounding factors) should be previously explained/justified.

We use directed acyclic graphs to obtain a picture of the relationship between an exposure (mass gathering events) and an outcome (COVID-19 disease) and the factors, which have a role of confounders. An adjusted analysis of these factors was implemented. The factors are age, sex, social class, chronic illness, family COVID-19 case, and falla (social group); all these factors could modify the association between exposure (MGEs assistance) and outcome (COVID-19 disease) (lines 243-251).

Lines 419-421.

Fig. 3. Directed acyclic graphs (DAG) of mass gathering events (exposure) effect on COVID-19 disease (outcome). Ancestors of exposure and outcome (in red). Based on DAGitty version 3.0.

The section Analysis of COVID-19 outbreak and MGEs should be divided in to “smaller” sections so as to facilitate a clear picture of the current results.

We divide the section into smaller sections following the suggestion of the reviewer (lines 401,444,476, and 522).

The discussion section should be addressed considering prior comments.

We add some important issues, including two tables of infection rate and the basic reproductive number (Ro), more detail of the outbreak, and an epilog of this study (lines 564-570, and 591-647).

Table 9. Estimation of the basic reproductive number (Ro) from the MGE COVID-19 outbreak between 6 and 10 March 2020 plus 14 days

Table 10. Attendance at pa-i-porta and Queen’s gala dinner MGEs and number of contacts (k) to obtain expected cases of COVID-19 compared with observed cases from the formula of Tupper and co-authors (63).

We have included new references of MEGs, how the MEGs are taking place now, and an epilog of our study: a cohort study of COVID-19 patients (lines 737-740).

Certain grammatical and reading errors are still observed. This version must be proofread and edited by a native English-speaking expert.

The manuscript has been reviewed by a native English-speaking professor.

Castelló de la Plana, May 8, 2021

Trusting in your decision, best wishes.

Dr. Alberto Arnedo-Pena,

On behalf of the authors of the manuscript.

Attachment

Submitted filename: Response to Reviewers.docx

Decision Letter 1

Simone Lolli

16 Aug 2021

“MASS GATHERING EVENTS AND COVID-19 TRANSMISSION IN BORRIANA (SPAIN): A RETROSPECTIVE COHORT STUDY.”

PONE-D-21-04796R1

Dear Dr. Arnedo-Pena,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Simone Lolli

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

**********

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The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Anna Wlodarczyk

Acceptance letter

Simone Lolli

19 Aug 2021

PONE-D-21-04796R1

“MASS GATHERING EVENTS AND COVID-19 TRANSMISSION IN BORRIANA (SPAIN): A RETROSPECTIVE COHORT STUDY.”

Dear Dr. Arnedo-Pena:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

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Kind regards,

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on behalf of

Dr. Simone Lolli

Academic Editor

PLOS ONE

Associated Data

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    (DTA)

    S2 Data

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    Attachment

    Submitted filename: Response to Reviewers.docx

    Data Availability Statement

    All relevant data are within the manuscript and its Supporting Information files.


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