Azithromycin for COVID-19 Treatment in Outpatients Nationwide

Phase 3 Terminated 263 enrolled Thomas M. Lietman Bill and Melinda Gates Foundation · collab Pfizer · collab Stanford University · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.

Timeline

Start: 2020-05-22
Primary completion: 2021-03-16
Completion: 2021-03-30

Outcome

Missed primary endpoint

Stopped: “Futility”

paper At day 14, there was no significant difference in proportion of participants who were symptom free (azithromycin: 50%; placebo: 50% PMID 34269813 ↗

paper treatment with a single dose of azithromycin compared with placebo did not result in greater likelihood of being symptom free at day 14. PMID 34269813 ↗

Publications

Oldenburg CE, Pinsky BA, Brogdon J, Chen C, Ruder K, Zhong L, Nyatigo F, Cook CA, Hinterwirth A, Lebas E, Redd T, Porco TC, Lietman TM, Arnold BF, Doan T. Effect of Oral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA. 2021 Aug 10;326(6):490-498. doi: 10.1001/jama.2021.11517.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azithromycin	Small molecule	1.2 g	Oral