Study characteristics |
Methods |
Trial design: double‐blind RCT with 2 parallel arms
Type of publication: journal publication
Setting: outpatient
Recruitment dates: July to September 2020
Country: Spain
Language: English
Number of centres: 1
Study purpose (treatment, prevention): treatment
Trial registration number: NCT04390022
Date of registration: 15 May 2020
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Participants |
Number of participants (randomized/analysed): 24/24
Age (median): overall 28 years
Males, n: overall 12 (50%)
Severity of condition according to study definition: outpatients with non‐severe symptoms
Severity of condition according to WHO scale: 2 to 3
Time from symptom onset to enrolment (median): intervention 1 (IQR 1 to 2) day, control 2 (IQR 1.5 to 2) days
Comorbidities: existing comorbidity was specified as exclusion criterion.
Virus detection performed at baseline (test‐positive at baseline): RT‐PCR (100%)
Vaccination status: NR, study period before vaccination was available
Inclusion criteria: consecutive outpatients attending the emergency department of the Clinica Universidad de Navarra (Pamplona, Spain) with symptoms compatible with COVID‐19; no more than 72 hours of fever or cough; positive PCR for SARS‐CoV‐2
Exclusion criteria: positive IgG against SARS‐CoV‐2; comorbidities considered risk factors for severe disease or COVID‐19 pneumonia at baseline
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Interventions |
-
Details of intervention
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Treatment details of control group
Concomitant therapy: NA
Duration of follow‐up: 28 days
Treatment cross‐overs: none
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Outcomes |
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Notes |
Date of publication: 23 February 2021
Sponsor/funding: departmental resources
Additional results posted in registry
Information on ethics votum: ethics committee approval by a nationally‐recognized ethics committee, as defined in the country's clinical trial regulations: approval number not reported, but approval letter provided by study author via personal communication
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