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Azithromycin for COVID-19 Treatment in Outpatients Nationwide (ACTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332107
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Pfizer
Stanford University
Information provided by (Responsible Party):
Thomas M. Lietman, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Drug: Azithromycin Drug: Placebos Phase 3

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 progression to hospitalization.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azithromycin
1.2g of oral azithromycin
Drug: Azithromycin
Participants will be shipped a single 1.2 g dose of oral azithromycin

Placebo Comparator: Placebo
Matching placebo
Drug: Placebos
Participants will be shipped a dose of matching placebo




Primary Outcome Measures :
  1. Hospitalization [ Time Frame: 14 days ]
    All-cause hospitalization or emergency room stay of >24 hours


Secondary Outcome Measures :
  1. Viral load [ Time Frame: 3 days ]
    Viral load by self-collected nasal swab

  2. Viral load [ Time Frame: 3 days ]
    Viral load by self-collected saliva swab

  3. Mortality [ Time Frame: 14 days ]
    All-cause mortality

  4. Adverse events [ Time Frame: 3 days ]
    Proportion of participants experiencing adverse events, including gastrointestinal side effects and rash

  5. Positive SARS-CoV-2 test - nasal swab [ Time Frame: 3 days ]
    Prevalence of positive SARS-CoV-2 test by self-collected nasal swab

  6. Positive SARS-CoV-2 test - saliva swab [ Time Frame: 3 days ]
    Prevalence of positive SARS-CoV-2 test by self-collected saliva swab

  7. Positive SARS-CoV-2 test - rectal swab [ Time Frame: 3 days ]
    Prevalence of positive SARS-CoV-2 test by self-collected rectal swab

  8. Genetic macrolide resistance determinants [ Time Frame: 3 days ]
    Prevalence of genetic macrolide resistance determinants by self-collected rectal swab

  9. COVID-19 symptoms [ Time Frame: 3, 7, 14, 21 days ]
    Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms

  10. Number of emergency room visits [ Time Frame: 14 days ]
    Number of emergency room visits <24 hours

  11. Number of household members with COVID-19 (confirmed or symptomatic) [ Time Frame: 14 days ]
    Number of household members with confirmed or symptomatic COVID-19

  12. Death [ Time Frame: 21 days ]
    Deaths within the study will be attempted to be matched with the US National Death Index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332107


Contacts
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Contact: Jessica M Brogdon, MPH (415) 514-1582 ACTIONTrial@ucsf.edu
Contact: Catherine Cook, MPH ACTIONTrial@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jessica M Brogdon, MPH    415-514-1582    ACTIONTrial@ucsf.edu   
Sponsors and Collaborators
Thomas M. Lietman
Bill and Melinda Gates Foundation
Pfizer
Stanford University
Investigators
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Principal Investigator: Catherine Oldenburg, ScD, MPH University of California, San Francisco
Principal Investigator: Thuy Doan, MD, PhD University of California, San Francisco
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Responsible Party: Thomas M. Lietman, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04332107    
Other Study ID Numbers: 20-30504
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents