Azithromycin for COVID-19 Treatment in Outpatients Nationwide

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-22

Study Completion Date

2021-03-30

Brief Summary

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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.

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Detailed Description

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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

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COVID-19 SARS-CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Azithromycin

1.2g of oral azithromycin

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Participants will be shipped a single 1.2 g dose of oral azithromycin

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Participants will be shipped a dose of matching placebo

Interventions

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Azithromycin

Participants will be shipped a single 1.2 g dose of oral azithromycin

Intervention Type DRUG

Placebos

Participants will be shipped a dose of matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Evidence of a positive SARS-CoV-2 test and test results received within the previous seven days
* Not currently hospitalized
* Willing and able to receive study drug by mail
* Willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via email or over the phone
* No known allergy or other contraindication to macrolides
* Age 18 years or older at the time of enrollment
* No known history of prolongation of the QT interval (eg. History of torsades de pointes, congenital long QT syndrome, bradyarrhthmia)
* No recent use of hydroxychloroquine within the past 7 days for participants \>55 years of age
* Not currently taking nelfinavir or warfarin (Coumadin)
* Provision of informed consent
* Not currently pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No