Clinical trial 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Keywords: SARS-CoV-2
COVID-19
Placebo
Duke University Health System
Outcomes
Duke Clinical Research Institute
ACTIV 6
ACTIV
montelukast
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: Vanderbilt University Medical Center
First posted: 2023-06-08
Enrollment: 1453
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-Blind, Placebo-Controlled, Randomized Trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting.

This proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization.

This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2.

Participants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo. The probability of placebo to treatment will remain the same regardless of eligibility decisions.

Eligible participants will be randomized (1:1), in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. As additional study drugs are added, the randomization will be altered to leverage placebo data across arms. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized.

All study visits are designed to be remote. However, screening and enrollment may occur in-person at sites and unplanned study visits may occur in-person or remotely, as deemed appropriate by the site investigator for safety purposes. Participants will be asked to complete questionnaires and report safety events during the study. Participants will be prompted by the online system to report safety events and these will be reviewed and confirmed via medical records and site staff, as necessary.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Sustained Recovery in Days
timeFrame: Up to 28 days
Secondary outcomes:
measure: Number of Participants With Hospitalization or Death
timeFrame: Up to 28 days
measure: Number of Participants With Mortality
timeFrame: Up to 28 days
measure: Time to Mortality
timeFrame: Up to 28 days
measure: Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
timeFrame: Up to 28 days
measure: Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
timeFrame: Day 7
measure: Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
timeFrame: Day 14
measure: Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
timeFrame: Day 28
measure: Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
timeFrame: Day 7, 14, 28, 90, 120, and 180
measure: Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
timeFrame: Day 7, 14, 28, 90, 120, and 180
measure: Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
timeFrame: Day 7, 14, 28, 90, 120, and 180
measure: Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
timeFrame: Day 7, 14, 28, 90, 120, and 180
measure: Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
timeFrame: Day 7, 14, 28, 90, 120, and 180
measure: Quality of Life (QOL) as Measured by the PROMIS-29 - Social
timeFrame: Day 7, 14, 28, 90, 120, and 180
measure: Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
timeFrame: Day 7, 14, 28, 90, and 120
measure: Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
timeFrame: Up to 14 days
measure: Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Gilbert
country: United States
facility: Lamb Health, LLC
state: Arizona
city: Mesa
country: United States
facility: First Care Medical Clinic
state: Arizona
city: Peoria
country: United States
facility: Trident Health Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas Medical Sciences
state: Arkansas
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: North Hollywood
country: United States
facility: Assuta Family Medical Group APMC
state: California
city: Palo Alto
country: United States
facility: Stanford
state: California
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
city: Colorado Springs
country: United States
facility: Doctors Medical Group of Colorado Springs, P.C.
state: Colorado
city: Colorado Springs
country: United States
facility: Pine Ridge Family Medicine Inc.
state: Colorado
city: Stamford
country: United States
facility: Tabitha B. Fortt, M.D., LLC
state: Connecticut
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Deerfield Beach
country: United States
facility: Arena Medical Group
state: Florida
city: Gainesville
country: United States
facility: Lupus Foundation of Gainesville
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Hialeah
country: United States
facility: L and A Morales Healthcare, Inc
state: Florida
city: Jacksonville
country: United States
facility: University of Florida-JAX-ASCENT
state: Florida
city: Jacksonville
country: United States
facility: AMRON Vitality and Wellness Center, LLC
state: Florida
city: Lake Mary
country: United States
facility: Sunshine Walk In Clinic
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Miami Lakes
country: United States
facility: The Angel Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Clinical Trials Inc.
state: Florida
city: Plantation
country: United States
facility: Lice Source Services Plantation
state: Florida
city: Saint Petersburg
country: United States
facility: Premier Health
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: The Villages
country: United States
facility: UF Health Precision Health Research
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: College Park
country: United States
facility: Essential Medical Care, Inc.
state: Georgia
city: Columbus
country: United States
facility: Clincept, LLC
state: Georgia
city: Conyers
country: United States
facility: HOPE Clinical Research and Wellness
state: Georgia
city: Cordele
country: United States
facility: David Kavtaradze MD, Inc.
state: Georgia
city: Douglasville
country: United States
facility: Elite Family Practice
state: Georgia
city: Loganville
country: United States
facility: Christ the King Health Care, P.C.
state: Georgia
city: Macon
country: United States
facility: Miller Family Practice, LLC
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Olivo Wellness Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore Medical Group
state: Illinois
city: Lake Zurich
country: United States
facility: Advanced Medical Care, Ltd
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Michigan City
country: United States
facility: Franciscan Health Michigan City
state: Indiana
city: Mishawaka
country: United States
facility: Del Pilar Medical and Urgent Care
state: Indiana
city: Wichita
country: United States
facility: University of Kansas - Wichita
state: Kansas
city: Central City
country: United States
facility: A New Start II, LLC
state: Kentucky
city: Alexandria
country: United States
facility: Christus Saint Frances Hospita
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center- New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Rockville
country: United States
facility: Jadestone Clinical Research, LLC
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Lawrence
country: United States
facility: Health Quality Primary Care
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Dearborn
country: United States
facility: Ananda Medical Clinic
state: Michigan
city: Detroit
country: United States
facility: GFC of Southeastern Michigan, PC
state: Michigan
city: Detroit
country: United States
facility: Romancare Health Services
state: Michigan
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri - Columbia
state: Missouri
city: Henderson
country: United States
facility: Comprehensive Pain Management and Endocrinology
state: Nevada
city: Bayonne
country: United States
facility: Focus Clinical Research Solutions
state: New Jersey
city: Matawan
country: United States
facility: Raritan Bay Primary Care & Cardiology Associates
state: New Jersey
city: Paterson
country: United States
facility: G&S Medical Associates, LLC
state: New Jersey
city: Turnersville
country: United States
facility: Mediversity Healthcare
state: New Jersey
city: Santa Fe
country: United States
facility: Christus St. Vincent Regional Medical Center
state: New Mexico
city: Clinton
country: United States
facility: Geriatrics and Medical Associates
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Yonkers
country: United States
facility: Spinal Pain and Medical Rehab, PC
state: New York
city: Clayton
country: United States
facility: Vaidya MD PLLC
state: North Carolina
city: Dunn
country: United States
facility: Maria Medical Center, PLLC
state: North Carolina
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Mooresville
country: United States
facility: Lapis Clinical Research
state: North Carolina
city: Smithfield
country: United States
facility: Superior Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Canton
country: United States
facility: Diabetes and Endocrinology Assoc. of Stark County
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Montgomery
country: United States
facility: TriHealth, Inc
state: Ohio
city: Durant
country: United States
facility: The Heart and Medical Center
state: Oklahoma
city: Hugo
country: United States
facility: Hugo Medical clinic
state: Oklahoma
city: Tulsa
country: United States
facility: Ascension St. John
state: Oklahoma
city: Morrisville
country: United States
facility: Bucks County Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Franklin
country: United States
facility: Clinical Trials Center of Middle TN
state: Tennessee
city: Hendersonville
country: United States
facility: Rapha Family Wellness
state: Tennessee
city: Knoxville
country: United States
facility: Medical Specialists of Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Allen
country: United States
facility: Express Family Clinic
state: Texas
city: Edinburg
country: United States
facility: DHR Health Institute for Research
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Physicians Group
state: Texas
city: Highlands
country: United States
facility: Highlands Medical Associates, P.A.
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Humble
country: United States
facility: Family Practice Doctors P.A.
state: Texas
city: Irving
country: United States
facility: Texas Health Physicians Group
state: Texas
city: Kingwood
country: United States
facility: Kintex Group Texas LLC, DBA Activian Clinical Research
state: Texas
city: Pasadena
country: United States
facility: University Diagnostics and Treatment Clinic
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Jeremy W. Szeto, D.O., P.A.
state: Texas
city: Weslaco
country: United States
facility: University of Texas Rio Grande Valley
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
Study officials:
affiliation: Duke Clinical Research Institute
name: Susanna Naggie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Clinical Research Institute
name: Adrian Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: