Montelukast for COVID-19

Recruiting in Palo Alto (17 mi)

+108 other locations

Overseen by Adrian Hernandez, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Susanna Naggie, MD

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing existing safe drugs to see if they can help non-hospitalized people with mild to moderate COVID-19 feel better faster and avoid severe outcomes. Participants will receive the study drug and will report their symptoms remotely.

Research Team

Susanna Naggie, MD

Principal Investigator

Duke Clinical Research Institute

Adrian Hernandez, MD

Principal Investigator

Duke Clinical Research Institute

Eligibility Criteria

This trial is for people aged 30 or older who have tested positive for COVID-19 within the last 10 days and are experiencing symptoms like fatigue, cough, or fever. They must not be hospitalized currently or in the past 10 days and should not have any known allergies to the study drug.

Inclusion Criteria

You are at least 30 years old.

You have tested positive for COVID-19 within the past 10 days.

You have had two or more symptoms of a new infection, like feeling tired, having trouble breathing, or a fever, for less than a week.

Exclusion Criteria

You have been diagnosed with COVID-19 more than 10 days before the screening.

Current or recent (within 10 days of screening) hospitalization

Known contraindication(s) to study drug including prohibited concomitant medications

Treatment Details

Interventions

• Montelukast (Leukotriene Inhibitor)
• Placebo (Other)

Trial Overview The ACTIV-6 trial is testing Montelukast, a repurposed medication, against a placebo to see if it can reduce symptoms in non-hospitalized patients with mild to moderate COVID-19. Participants will report their symptoms remotely without needing in-person visits unless necessary.

Participant Groups

Group I: Arm F - Montelukast Experimental Treatment 1 Intervention

Montelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.

Group II: Arm F - Placebo Placebo Group 1 Intervention

Placebo - 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.

Montelukast is already approved in Canada for the following indications:

Approved in Canada as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

George Washington University Hospital Washington, United States

University of Texas Health Science Center at Houston Houston, TX

Lamb Health, LLC Gilbert, AZ

Pine Ridge Family Medicine Inc. Colorado Springs, CO

More Trial Locations

Who Is Running the Clinical Trial?

Susanna Naggie, MD

Lead Sponsor

Trials

8

Recruited

22,800+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Joni L. Rutter

National Center for Advancing Translational Sciences (NCATS)

Chief Executive Officer since 2022

PhD in Pharmacology

Dominique C. Pichard

National Center for Advancing Translational Sciences (NCATS)

Chief Medical Officer since 2023

MD