Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT05894577

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

Official Title:

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Summary

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.

Eligibility

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Disease(s) and\or Condition(s)

Covid19

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: OTHER
    • Name: Placebo
    • Description: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
    • Arm Group Labels: Arm F - Placebo
    • Type: DRUG
    • Name: Montelukast
    • Description: Montelukast sodium is a white to off-white powder. The 10 mg montelukast tablets are beige, rounded square-shaped, biconvex, film-coated tablets. Each tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg montelukast. All packaging will be labeled to indicate that the product is for investigational use.
    • Arm Group Labels: Arm F - Montelukast
Sponsor
  • Susanna Naggie, MD