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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332107
Recruitment Status : Terminated (Futility)
First Posted : April 2, 2020
Results First Posted : September 9, 2021
Last Update Posted : October 7, 2021
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Pfizer
Stanford University
Information provided by (Responsible Party):
Thomas M. Lietman, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE March 30, 2020
First Posted Date  ICMJE April 2, 2020
Results First Submitted Date  ICMJE August 9, 2021
Results First Posted Date  ICMJE September 9, 2021
Last Update Posted Date October 7, 2021
Actual Study Start Date  ICMJE May 22, 2020
Actual Primary Completion Date March 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2021)
Number of Participants Who Were Symptom Free at Day 14 [ Time Frame: 14 days ]
Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no)
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
Hospitalization [ Time Frame: 14 days ]
All-cause hospitalization
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2021)
  • Viral Load [ Time Frame: 3 days ]
    Viral load by self-collected nasal swab
  • Viral Load [ Time Frame: 3 days ]
    Viral load by self-collected saliva swab
  • Mortality [ Time Frame: 14 days ]
    All-cause mortality
  • Adverse Events [ Time Frame: 3 days ]
    Percentage of participants experiencing adverse events, including gastrointestinal side effects and rash
  • Positive SARS-CoV-2 Test - Nasal Swab [ Time Frame: 3 days ]
    Prevalence of positive SARS-CoV-2 test by self-collected nasal swab
  • Positive SARS-CoV-2 Test - Saliva Swab [ Time Frame: 3 days ]
    Prevalence of positive SARS-CoV-2 test by self-collected saliva swab
  • Positive SARS-CoV-2 Test - Rectal Swab [ Time Frame: 3 days ]
    Prevalence of positive SARS-CoV-2 test by self-collected rectal swab
  • Genetic Macrolide Resistance Determinants [ Time Frame: 3 days ]
    Prevalence of genetic macrolide resistance determinants by self-collected rectal swab
  • Secondary Outcomes Through Day 21 [ Time Frame: Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days) ]
    Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms through Day 21
  • Number of Participants With Emergency Room Visits [ Time Frame: 21 days ]
    Number of emergency room visits <24 hours
  • Number of Household Members With COVID-19 (Confirmed or Symptomatic) [ Time Frame: 21 days ]
    Number of household members with confirmed or symptomatic COVID-19 through Day 21
  • Number of Participants That Died [ Time Frame: 21 days ]
    Deaths within the study
  • Number of Participants Reporting Hospitalization [ Time Frame: 21 Days ]
    Number of hospitalizations defined as a hospital stay or ER stay longer than 24 hours through 21 days post enrollment
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • Viral load [ Time Frame: 7 days ]
    Viral load by self-collected nasal swab
  • Viral load [ Time Frame: 7 days ]
    Viral load by self-collected saliva swab
  • Mortality [ Time Frame: 14 days ]
    All-cause mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Azithromycin for COVID-19 Treatment in Outpatients Nationwide
Official Title  ICMJE Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • SARS-CoV-2
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Azithromycin
    1.2g of oral azithromycin
    Intervention: Drug: Azithromycin
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebos
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 9, 2021)
263
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
2271
Actual Study Completion Date  ICMJE March 30, 2021
Actual Primary Completion Date March 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04332107
Other Study ID Numbers  ICMJE 20-30504
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Current Responsible Party Thomas M. Lietman, University of California, San Francisco
Original Responsible Party University of California, San Francisco
Current Study Sponsor  ICMJE Thomas M. Lietman
Original Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • Bill and Melinda Gates Foundation
  • Pfizer
  • Stanford University
Investigators  ICMJE
Principal Investigator: Catherine Oldenburg, ScD, MPH University of California, San Francisco
Principal Investigator: Thuy Doan, MD, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP