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
participants :
Azithromycin=171
Placebo=92
Characteristics of participants
N= 263
Mean age : NR
86 males
Severity : Mild: n= 245/ Asymptomatic: n=18
Number of vaccinated participants: NR
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 willing stated in the publication:

Yes
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.