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Leukotriene Inhibitor

Montelukast for COVID-19

Phase 3

Waitlist Available

Led By Adrian Hernandez, MD

Research Sponsored by Susanna Naggie, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7, 14, 28, 90, and 120

Awards & highlights

Study Summary

This trial looks at how existing drugs can help people with mild-moderate COVID-19 symptoms. Participants will get a study drug or a placebo and report any changes in symptoms. All remote, with in-person visits if needed.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of Montelukast in this context aren't detailed here, common ones include headache, stomach pain, heartburn, upset stomach, nausea, diarrhea; serious side effects may occur but are rare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7, 14, 28, 90, and 120

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7, 14, 28, 90, and 120

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, 14, 28, 90, and 120 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to sustained recovery in Days

Secondary outcome measures

Mean Days Benefit as Measured by the Symptom and Clinical Event Scale

Number of Participants With Hospitalization or Death

Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death

+13 more

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462

16%

Cold/Upper Respiratory Infection

10%

Diarrhea

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Montelukast

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm F - MontelukastExperimental Treatment1 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 - PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Montelukast

2008

Completed Phase 4

~15460

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterOTHER

856 Previous Clinical Trials

670,789 Total Patients Enrolled

Susanna Naggie, MDLead Sponsor

7 Previous Clinical Trials

37,205 Total Patients Enrolled

National Center for Advancing Translational Sciences (NCATS)NIH

320 Previous Clinical Trials

400,327 Total Patients Enrolled

Media Library

Montelukast (Leukotriene Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05894577 — Phase 3

Coronavirus Research Study Groups: Arm F - Placebo, Arm F - Montelukast

Coronavirus Clinical Trial 2023: Montelukast Highlights & Side Effects. Trial Name: NCT05894577 — Phase 3

Montelukast (Leukotriene Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05894577 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration authorized Arm F - Montelukast?

"Considering the Phase 3 status of this trial, our team at Power bestowed a score of 3 to Arm F - Montelukast's safety rating due to evidence in favor of its efficacy and multiple rounds that grant assurance towards its security."

Answered by AI

Are there openings remaining in this research endeavor for prospective participants?

"Affirmative. Clinicaltrials.gov hosts data which verifies that this clinical trial, first posted on January 27th 2023, is actively seeking participants. The research requires 1400 patients to be recruited from 104 sites across the country."

Answered by AI

How many locales is the clinical experiment being conducted in?

"The 105 sites associated with this trial are recruiting participants, including Lamb Health LLC in Gilbert Arkansas, First Care Medical Clinic in Mesa California and Trident Health Center in Peoria Colorado."

Answered by AI

How many individuals are enrolled in this trial?

"Correct. Clinicaltrials.gov confirms that this medical study, initially posted on January 27th 2023, is actively seeking new participants. A total of 1400 individuals must be recruited from 104 different clinical trial sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Susanna Naggie, MD 2023. "ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05894577.

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