ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)
ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
2 other identifiers
interventional
1,453
1 country
109
Brief Summary
The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person. Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Jan 2023
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2023
CompletedFirst Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedResults Posted
Study results publicly available
August 16, 2024
CompletedJanuary 17, 2025
December 1, 2024
6 months
June 6, 2023
July 19, 2024
December 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Sustained Recovery in Days
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Up to 28 days
Secondary Outcomes (16)
Number of Participants With Hospitalization or Death
Up to 28 days
Number of Participants With Mortality
Up to 28 days
Time to Mortality
Up to 28 days
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
Up to 28 days
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
Day 7
- +11 more secondary outcomes
Study Arms (2)
Arm F - Montelukast
EXPERIMENTALMontelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.
Arm F - Placebo
PLACEBO COMPARATORPlacebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Interventions
Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
Montelukast sodium is a white to off-white powder. The 10 mg montelukast tablets are beige, rounded square-shaped, biconvex, film-coated tablets. Each tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg montelukast. All packaging will be labeled to indicate that the product is for investigational use.
Eligibility Criteria
You may qualify if:
- Completed Informed Consent
- Age ≥ 30 years old
- Confirmed SARS-CoV-2 infection (or reinfection) by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
- Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
You may not qualify if:
- Prior diagnosis of COVID-19 infection (\> 10 days from screening)
- Current or recent (within 10 days of screening) hospitalization
- Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo
- Known contraindication(s) to study drug including prohibited concomitant medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (109)
Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
Lamb Health, LLC
Gilbert, Arizona, 85298, United States
First Care Medical Clinic
Mesa, Arizona, 85203, United States
Trident Health Center
Peoria, Arizona, 85382, United States
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Assuta Family Medical Group APMC
North Hollywood, California, 91606, United States
Stanford
Palo Alto, California, 94304, United States
Olive View - UCLA Medical Center
Sylmar, California, 91342, United States
Doctors Medical Group of Colorado Springs, P.C.
Colorado Springs, Colorado, 80917, United States
Pine Ridge Family Medicine Inc.
Colorado Springs, Colorado, 80924, United States
Tabitha B. Fortt, M.D., LLC
Stamford, Connecticut, 06905, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Arena Medical Group
Deerfield Beach, Florida, 33441, United States
Lupus Foundation of Gainesville
Gainesville, Florida, 32606, United States
University of Florida Health
Gainesville, Florida, 32611, United States
L and A Morales Healthcare, Inc
Hialeah, Florida, 33012, United States
University of Florida-JAX-ASCENT
Jacksonville, Florida, 32209, United States
AMRON Vitality and Wellness Center, LLC
Jacksonville, Florida, 32244, United States
Sunshine Walk In Clinic
Lake Mary, Florida, 32746, United States
Lakeland Regional Medical Center
Lakeland, Florida, 33805, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, 33136, United States
Well Pharma Medical Research
Miami, Florida, 33173, United States
The Angel Medical Research Corporation
Miami Lakes, Florida, 33016, United States
Innovation Clinical Trials Inc.
Palmetto Bay, Florida, 33157, United States
Lice Source Services Plantation
Plantation, Florida, 33313, United States
Premier Health
St. Petersburg, Florida, 33707, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
UF Health Precision Health Research
The Villages, Florida, 32159, United States
Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
Emory Healthcare
Atlanta, Georgia, 30322, United States
Essential Medical Care, Inc.
College Park, Georgia, 30349, United States
Clincept, LLC
Columbus, Georgia, 31904, United States
HOPE Clinical Research and Wellness
Conyers, Georgia, 30094, United States
David Kavtaradze MD, Inc.
Cordele, Georgia, 31015, United States
Elite Family Practice
Douglasville, Georgia, 30134, United States
Christ the King Health Care, P.C.
Loganville, Georgia, 30052, United States
Miller Family Practice, LLC
Macon, Georgia, 31201, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Olivo Wellness Medical Center
Chicago, Illinois, 60618, United States
NorthShore Medical Group
Evanston, Illinois, 60201, United States
Advanced Medical Care, Ltd
Lake Zurich, Illinois, 60047, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Franciscan Health Michigan City
Michigan City, Indiana, 46360, United States
Del Pilar Medical and Urgent Care
Mishawaka, Indiana, 46545, United States
University of Kansas - Wichita
Wichita, Kansas, 67214, United States
A New Start II, LLC
Central City, Kentucky, 42330, United States
Christus Saint Frances Hospita
Alexandria, Louisiana, 71301, United States
University Medical Center- New Orleans
New Orleans, Louisiana, 70112, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287-1900, United States
Jadestone Clinical Research, LLC
Rockville, Maryland, 20855, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Health Quality Primary Care
Lawrence, Massachusetts, 01843, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Ananda Medical Clinic
Dearborn, Michigan, 48124, United States
GFC of Southeastern Michigan, PC
Detroit, Michigan, 48202, United States
Romancare Health Services
Detroit, Michigan, 48206, United States
Essentia Health
Duluth, Minnesota, 55805, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Missouri - Columbia
Columbia, Missouri, 65212, United States
Comprehensive Pain Management and Endocrinology
Henderson, Nevada, 89052, United States
Focus Clinical Research Solutions
Bayonne, New Jersey, 07002, United States
Raritan Bay Primary Care & Cardiology Associates
Matawan, New Jersey, 07747, United States
G&S Medical Associates, LLC
Paterson, New Jersey, 07514, United States
Mediversity Healthcare
Turnersville, New Jersey, 08012, United States
Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, 87505, United States
Geriatrics and Medical Associates
Clinton, New York, 13323, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Spinal Pain and Medical Rehab, PC
Yonkers, New York, 10701, United States
Vaidya MD PLLC
Clayton, North Carolina, 27520, United States
Maria Medical Center, PLLC
Dunn, North Carolina, 28334, United States
Duke Clinical Research Institute
Durham, North Carolina, 27701, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Lapis Clinical Research
Mooresville, North Carolina, 28117, United States
Superior Clinical Research
Smithfield, North Carolina, 27577, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27151, United States
Diabetes and Endocrinology Assoc. of Stark County
Canton, Ohio, 44718, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
TriHealth, Inc
Montgomery, Ohio, 45242, United States
The Heart and Medical Center
Durant, Oklahoma, 74701, United States
Hugo Medical clinic
Hugo, Oklahoma, 74743, United States
Ascension St. John
Tulsa, Oklahoma, 74104, United States
Bucks County Clinical Research
Morrisville, Pennsylvania, 19067, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Clinical Trials Center of Middle TN
Franklin, Tennessee, 37067, United States
Rapha Family Wellness
Hendersonville, Tennessee, 37075, United States
Medical Specialists of Knoxville
Knoxville, Tennessee, 37938, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Express Family Clinic
Allen, Texas, 75013, United States
DHR Health Institute for Research
Edinburg, Texas, 78539, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Texas Health Physicians Group
Fort Worth, Texas, 76107, United States
Highlands Medical Associates, P.A.
Highlands, Texas, 77562, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Family Practice Doctors P.A.
Humble, Texas, 77338, United States
Texas Health Physicians Group
Irving, Texas, 75039, United States
Kintex Group Texas LLC, DBA Activian Clinical Research
Kingwood, Texas, 77339, United States
University Diagnostics and Treatment Clinic
Pasadena, Texas, 77504, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Jeremy W. Szeto, D.O., P.A.
Sugar Land, Texas, 77479, United States
University of Texas Rio Grande Valley
Weslaco, Texas, 78596, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The first 202 participants to enroll to the montelukast study arm enrolled under protocol version 6, which only included follow-up through 120 days. The remainder of those enrolled to this study arm were consented to participate in the study up to 180 days. Of the 202 participants who enrolled under protocol version 6, two participants responded to Day 180 survey questions. Those participants are included in the Day 180 analysis to utilize all available responses.
Results Point of Contact
- Title
- Susanna Naggie, MD
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Susanna Naggie, MD
Duke Clinical Research Institute
- PRINCIPAL INVESTIGATOR
Adrian Hernandez, MD
Duke Clinical Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo because they will be matching.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 8, 2023
Study Start
January 27, 2023
Primary Completion
July 31, 2023
Study Completion
January 1, 2024
Last Updated
January 17, 2025
Results First Posted
August 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- Up to 36 months after publication
- Access Criteria
- Interested investigators will need to seek prior IRB approval before access to any data is granted.
We will share this data after it has been de-identified. We will share data beginning around 6 months after publication and for up to 36 months afterward. Access will only be shared with those who have obtained prior IRB approval to be able to access this data.