NCT04332107

Azithromycin for COVID-19 Treatment in Outpatients Nationwide

Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Thomas M. Lietman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Identification of a safe, effective treatment for individuals with mild or moderate COVID-19 that prevents disease progression and reduces hospitalization would reduce the burden on the health system. High dose hydroxychloroquine is being evaluated for SARS-CoV-2 prevention and COVID-19 disease treatment, but has a high risk of a number of potentially severe adverse events. Recent evidence has indicated that the broad-spectrum macrolide azithromycin may have some activity against coronaviruses. Here we propose an individually-randomized, placebo-controlled trial to determine the efficacy of a single dose of azithromycin for prevention of COVID-19. Potential participants will undergo remote eligibility screening with study staff prior to enrollment. Upon determination of eligibility and signing electronic informed consent documents, participants will be emailed baseline study forms and will be mailed their randomized study treatment. At the end of the study (21 days), participants will be emailed a final study questionnaire. Note that there will no contact between study staff and participants in this trial, minimizing risk of infection spread.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	Azithromycin	Participants will be shipped a single 1.2 g dose of oral azithromycin
DRUG	Placebos	Participants will be shipped a dose of matching placebo

Timeline

• Start date: 2020-05-22
• Primary completion: 2021-03-16
• Completion: 2021-03-30
• First posted: 2020-04-02
• Last updated: 2023-03-02
• Results posted: 2021-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study