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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
Pivotal Trial

Summary

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.

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Sustained Recovery in Days
Secondary study objectives
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
+10 more

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462
16%
Cold/Upper Respiratory Infection
10%
Diarrhea
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Montelukast
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for COVID-19 include antiviral agents, immune response modulators, and symptom relief medications. Antiviral agents, such as nirmatrelvir/ritonavir (Paxlovid), work by inhibiting viral replication, thereby reducing the viral load in the body. Immune response modulators, like dexamethasone, help to control the body's inflammatory response, which can prevent severe complications such as acute respiratory distress syndrome (ARDS). Symptom relief medications, including antipyretics and analgesics like acetaminophen, manage fever and pain, improving patient comfort. These mechanisms are crucial as they target different aspects of the disease, from reducing viral proliferation to managing the immune response and alleviating symptoms, thereby providing a comprehensive approach to treatment.
Application of Traditional Chinese Medicine and Systems Pharmacology in Drug Prevention and Treatment against COVID-19.A Review on Repurposed Drugs and Vaccine Trials for Combating SARS CoV-2.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterOTHER
894 Previous Clinical Trials
933,130 Total Patients Enrolled
Susanna Naggie, MDLead Sponsor
7 Previous Clinical Trials
37,205 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
354 Previous Clinical Trials
407,804 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
~545 spots leftby Oct 2025