ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)

Completed · Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT05894577

Run by

Susanna Naggie, MD

People needed

1453

Starts

2023-01-27

Expected to finish

2024-01-01

Last updated by the study team

2025-01-17

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Lamb Health, LLC — Gilbert, Arizona, United States
• First Care Medical Clinic — Mesa, Arizona, United States
• Trident Health Center — Peoria, Arizona, United States
• University of Arkansas Medical Sciences — Little Rock, Arkansas, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Assuta Family Medical Group APMC — North Hollywood, California, United States
• Stanford — Palo Alto, California, United States
• Olive View - UCLA Medical Center — Sylmar, California, United States
• Doctors Medical Group of Colorado Springs, P.C. — Colorado Springs, Colorado, United States
• Pine Ridge Family Medicine Inc. — Colorado Springs, Colorado, United States
• Tabitha B. Fortt, M.D., LLC — Stamford, Connecticut, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• Arena Medical Group — Deerfield Beach, Florida, United States
• Lupus Foundation of Gainesville — Gainesville, Florida, United States
• University of Florida Health — Gainesville, Florida, United States
• L and A Morales Healthcare, Inc — Hialeah, Florida, United States
• University of Florida-JAX-ASCENT — Jacksonville, Florida, United States
• AMRON Vitality and Wellness Center, LLC — Jacksonville, Florida, United States
• Sunshine Walk In Clinic — Lake Mary, Florida, United States
• Lakeland Regional Medical Center — Lakeland, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Well Pharma Medical Research — Miami, Florida, United States
• The Angel Medical Research Corporation — Miami Lakes, Florida, United States
• Chandler Regional Medical Center — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.