Table 1.

Clinical trials on BCG vaccine usage for prevention of COVID-19, Available from: https://clinicaltrials.gov/at 2020 September 1

NCT Number	Title	Recruiting	Interventions	Outcome Measures	Age	Phase	Enrollment	Study Type	Study Designs	Start Date	Completion Date	Locations
NCT04328441	Reducing Health Care Workers Absenteeism in Covid-19 Pandemic Through BCG Vaccine	Yes	BCG Vaccine | Placebo	Health Care Workers absenteeism/the cumulative incidence of documented COVID-19/Hospital Admission due to documented COVID-19 and any reason, self-reported acute respiratory symptoms or fever/death due to documented COVID-19/ICU Admission due to documented COVID-19 and any reason/the cumulative incidence of self-reported fever/self-reported acute respiratory symptoms/death for any reason/the number of days of unplanned absenteeism, because of documented COVID-19, because of imposed quarantine as a result of exposure to COVID-19, because of imposed quarantine as a result of having acute respiratory symptoms/fever or documented COVID-19, because of self-reported acute respiratory symptoms/the number of days of self-reported fever [>38 deg C]/the number of days of self-reported acute respiratory symptoms/the cumulative incidence and magnitude of plasma-serum antibodies [IgA,M,G] and SARS-CoV-2-specific antibodies at 12 weeks after vaccination and at the end of the study period	18<	3	1500	Interventional	Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | Primary Purpose: Prevention	Mar-20	Dec-20	Netherlands
NCT04362124	Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection	Not yet	BCG Vaccine | Placebo	Incidence of COVID-19 cases confirmed or probable in the study population/Incidence of severe or critical infection in COVID-19 cases, Lethality of the infection in both groups, Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination, Prevalence of SARS-Cov-2 infection	18–65	3	1000	Interventional	Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | Primary Purpose: Supportive Care	Apr-20	Nov-21	Colombia
NCT04379336	BCG Vaccination for Healthcare Workers in COVID-19 Pandemic	Yes	BCG Vaccine | Placebo	Incidence of HCWs hospitalized due to COVID-19 per arm | Incidence of SARS-CoV-2 infection per arm | Incidence of upper respiratory tract infections per arm | Days of unplanned absenteeism due to COVID-19 or any reason per arm | Incidence of hospitalization for any reason per arm | Incidence of ICU admission per arm | Incidence of death per arm | Prevalence of latent TB infection | Incidence of active TB per arm | Compare the effect of latent TB on morbidity and mortality due to COVID-19 per arm | Incidence of treatment related adverse events	18<	3	500	Interventional	Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | Primary Purpose: Prevention	May-20	Apr-21	South Africa
NCT04350931	Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19	Not yet	BCG Vaccine | Placebo	incidence of confirmed COVID-19 | Effectiveness of BCG vaccine	18<	3	900	Interventional	Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Single (Participant) | Primary Purpose: Prevention	Apr-20	Dec-20	Egypt
NCT04417335	Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination	Active	BCG Vaccine | Placebo	SARS-CoV-2 related hospital admission | the duration of hospital admission due to documented COVID-19 | the cumulative incidence of documented SARS-CoV-2 infection, self-reported acute respiratory symptoms or fever, death due to documented SARS-CoV-2 infection, hospital admission for any reason, ICU Admission due to documented SARS-CoV-2 infection	60<	4	2014	Interventional	Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Single (Participant) | Primary Purpose: Prevention	Apr-20	May-21	Netherlands
NCT04347876	Outcome of COVID-19 Cases Based on Tuberculin Test: Can Previous BCG Alter the Prognosis?	Yes	Diagnostic Test: Tuberculin test	Pneumonia severity index | Need for ICU admission | COVID −19 test conversion | Mortality	12–80		100	Observational	Observational Model: Case-Control | Time Perspective: Prospective	Apr-20	Jun-20	Egypt
NCT04475302	BCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 Hotspots	Yes	BCG Vaccine | Placebo	Mortality due to COVID-19 disease | Hospital admission and ICU admission due to Covid-19, Severity of Covid-19 (mild, moderate or severe), Hospital admission due to other respiratory febrile illness, immunological outcomes in the sub study	60–80	3	2175	Interventional	Allocation: Non-Randomized | Intervention Model: Single Group Assignment | Masking: None (Open Label) | Primary Purpose: Prevention	Jul-20	May-21	India
NCT04461379	Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers	Not yet	BCG Vaccine | Placebo	Demonstrate COVID- 19 disease incidence, cumulative hospitalization, specific Antibodies against SARS-CoV-2 at 3 and 6 months among Health care workers | Hospitalization, Oxygen supplementation in severe disease COVID-19 | Need for intubation or noninvasive ventilation for the patient. | Critical care admission with SARS-CoV2 | Mortality associated to progressive pulmonary disease | safety of the vaccine by measuring the incidence rates of local and systemic adverse effects that occur after one month its application. | Incidence of COVID-19 complications | Mean days of hospitalization and days in ICU by COIVD-19 | Cost associated with in-hospital medical care | Scores of the Clinical Prediction Rules associated with mortality using Sequential Organ Failure Assessment (SOFA score) | Scores of the Clinical Prediction Rules associated with mortality using Acute Physiology and Chronic Health disease Classification System (APACHE) | Alteration profile in laboratory studies | Registration of chronic medications | Need for vasopressors	18<	3	908	Interventional	Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Triple (Participant, Care Provider, Outcomes Assessor) | Primary Purpose: Prevention	Jul-20	Jan-21	Mexico

Quadruple masking: P = Participant, C = Care Provider, I = Investigator, O = Outcomes Assessor