Azithromycin for COVID-19 Treatment in Outpatients Nationwide

COVID-19 Clinical Trial

— ACTION  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04332107
• Other study ID #: 20-30504
• Status: Terminated
• Phase: Phase 3
• Start date: May 22, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: February 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 263
• Est. completion date: March 30, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Drug:
• Azithromycin
Participants will be shipped a single 1.2 g dose of oral azithromycin
• Placebos
Participants will be shipped a dose of matching placebo

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
Thomas M. Lietman	Bill and Melinda Gates Foundation, Pfizer, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Were Symptom Free at Day 14	Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no)	14 days
Secondary	Viral Load - Nasal Swab	Viral load by self-collected nasal swab	3 days
Secondary	Viral Load - Saliva Swab	Viral load by self-collected saliva swab	3 days
Secondary	Mortality	All-cause mortality	14 days
Secondary	Adverse Events	Percentage of participants experiencing adverse events, including gastrointestinal side effects and rash	3 days
Secondary	Positive SARS-CoV-2 Test - Nasal Swab	Prevalence of positive SARS-CoV-2 test by self-collected nasal swab	3 days
Secondary	Positive SARS-CoV-2 Test - Saliva Swab	Prevalence of positive SARS-CoV-2 test by self-collected saliva swab	3 days
Secondary	Positive SARS-CoV-2 Test - Rectal Swab	Prevalence of positive SARS-CoV-2 test by self-collected rectal swab	3 days
Secondary	Genetic Macrolide Resistance Determinants	Prevalence of genetic macrolide resistance determinants by self-collected rectal swab	3 days
Secondary	Secondary Outcomes Through Day 21	Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms through Day 21	Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days)
Secondary	Number of Participants With Emergency Room Visits	Number of emergency room visits <24 hours	21 days
Secondary	Number of Household Members With COVID-19 (Confirmed or Symptomatic)	Number of household members with confirmed or symptomatic COVID-19 through Day 21	21 days
Secondary	Number of Participants That Died	Deaths within the study	21 days
Secondary	Number of Participants Reporting Hospitalization	Number of hospitalizations defined as a hospital stay or ER stay longer than 24 hours through 21 days post enrollment	21 Days