What side effects are associated with this type of intervention?

Common treatments for COVID-19 include repurposed medications such as dexamethasone, nirmatrelvir/ritonavir (Paxlovid), fluvoxamine, ivermectin, and hydroxychloroquine. Dexamethasone, a steroid, can cause psychiatric side effects like depression, emotional lability, and insomnia. Nirmatrelvir/ritonavir may lead to gastrointestinal issues and has potential for drug-drug interactions. Fluvoxamine, an antidepressant, has been associated with gastrointestinal symptoms and potential drug interactions. Ivermectin, although not recommended due to lack of efficacy, can cause neurologic adverse effects, especially when misused. Hydroxychloroquine has been linked to gastrointestinal symptoms and, in some cases, cardiac arrhythmias.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, focusing on different mechanisms of action. Remdesivir, an antiviral drug, targets viral replication and has been approved for use in hospitalized patients. Dexamethasone, a corticosteroid, modulates the immune response and is used to reduce inflammation in severe cases. Additionally, monoclonal antibodies like bamlanivimab and etesevimab have been authorized for emergency use to help the immune system fight the virus. These treatments align with the approaches being studied in trials of repurposed medications, which aim to reduce symptoms and prevent disease progression.

What other types of research exist?

Promising novel alternatives to repurposed medications for treating COVID-19 in 2024 include nirmatrelvir-ritonavir (Paxlovid), remdesivir, and high-titer convalescent plasma. These treatments have shown efficacy in reducing hospitalization and severe outcomes. Additionally, monoclonal antibodies and inhaled corticosteroids are being explored as potential options.

← Back to Search

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 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

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

Vomiting

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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.