Covid-19 Living Data

Trial NCT04332107
Publication Oldenburg CE, JAMA, 2021 (published paper)
Dates: 2020-05-22 to 2021-03-16
Funding: Mixed (Bill & Melinda Gates Foundation, intervention drugs were donated by Pfizer Inc.)
Conflict of interest: No

Methods
	RCT Blinding: quadruple blinding
	Location : Multicenter / USA Follow-up duration (days): 21
Inclusion criteria	Documented positive SARS-CoV-2 test result (nucleic acid amplification or antigen) within 7 days before enrollment; not required to be symptomatic
Exclusion criteria	Younger than 18 years; self-reported macrolide allergy; concurrently taking hydroxychloroquine if they were older than 55 years (to reduce the potential risk of QT-interval prolongation); concurrently taking nelfinavir or warfarin; currently pregnant (self-report); unable to receive study drug in the mail or to complete online questionnaires
Interventions
	Treatment Azithromycin 1.2 g orally once-off
	Control Placebo
Participants
	Randomized 263 participants (n₁=171 / n₂= 92)
	Characteristics of participants N=263 Mean age : NR 86 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
	In the register Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no)
	In the report Self-reported absence of COVID-19 symptoms at day 14
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the study registry, protocol, and statistical analysis plan were used in data extraction and risk of bias assessment. The study was terminated at interim analysis by the data monitoring board due to futility, consequently, planned sample size was not reached. There is no change from the trial registration in the intervention and control treatments. The primary outcome changed from hospitalization to absence of symptoms during the course of the trial, with consultation and approval by the data monitoring board.