Back to results

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

Primary Purpose

Covid19

Status

Active

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Placebo

Montelukast

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, COVID-19, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, ACTIV 6, ACTIV, montelukast

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm F - Montelukast

Arm F - Placebo

Arm Description

Montelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.

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.

Outcomes

Primary Outcome Measures

Time to sustained recovery in Days

Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.

Secondary Outcome Measures

Number of Participants With Hospitalization or Death

Number of Participants With Mortality

Time to mortality

Time to mortality was the number of days between drug receipt and death.

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

Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.

COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.

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.

Quality of Life (QOL) as measured by the PROMIS-29 - Physical Function

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.

Quality of Life (QOL) as measured by the PROMIS-29 - Fatigue

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.

Quality of Life (QOL) as measured by the PROMIS-29 - Pain

Quality of Life (QOL) as measured by the PROMIS-29 - Depression

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domain with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.

Quality of Life (QOL) as measured by the PROMIS-29 - Anxiety

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.

Quality of Life (QOL) as measured by the PROMIS-29 - Social

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.

Quality of Life (QOL) as measured by the PROMIS-29 - Sleep

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.

Time Unwell in Days as Measured by the Symptom and Clinical Event Scale

The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.

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

The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.

Full Information

NCT ID

NCT05894577

First Posted

June 6, 2023

Last Updated

July 3, 2023

Sponsor

Susanna Naggie, MD

Collaborators

National Center for Advancing Translational Sciences (NCATS), Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05894577

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 27, 2023 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

January 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Susanna Naggie, MD

Collaborators

National Center for Advancing Translational Sciences (NCATS), Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

SARS-CoV-2, COVID-19, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, ACTIV 6, ACTIV, montelukast

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Double-Blind, Placebo-Controlled, Randomized Trial

Masking

ParticipantCare Provider

Masking Description

The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo because they will be matching.

Allocation

Randomized

Enrollment

1403 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm F - Montelukast

Arm Type

Experimental

Arm Description

Montelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.

Arm Title

Arm F - Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Montelukast

Intervention 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.

Primary Outcome Measure Information:

Title

Time to sustained recovery in Days

Description

Time Frame

Up to 28 days

Secondary Outcome Measure Information:

Title

Number of Participants With Hospitalization or Death

Time Frame

Up to 28 days

Title

Number of Participants With Mortality

Time Frame

Up to 28 days

Title

Time to mortality

Description

Time to mortality was the number of days between drug receipt and death.

Time Frame

Up to 28 days

Title

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

Time Frame

Up to 28 days

Title

Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7.

Description

Time Frame

Day 7

Title

Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.

Description

Time Frame

Day 14

Title

Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.

Description

Time Frame

Day 28

Title

Quality of Life (QOL) as measured by the PROMIS-29 - Physical Function

Description

Time Frame

Day 7, 14, 28, 90, and 120

Title

Quality of Life (QOL) as measured by the PROMIS-29 - Fatigue

Description

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.

Time Frame

Day 7, 14, 28, 90, and 120

Title

Quality of Life (QOL) as measured by the PROMIS-29 - Pain

Description

Time Frame

Day 7, 14, 28, 90, and 120

Title

Quality of Life (QOL) as measured by the PROMIS-29 - Depression

Description

Time Frame

Day 7, 14, 28, 90, and 120

Title

Quality of Life (QOL) as measured by the PROMIS-29 - Anxiety

Description

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.

Time Frame

Day 7, 14, 28, 90, and 120

Title

Quality of Life (QOL) as measured by the PROMIS-29 - Social

Description

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.

Time Frame

Day 7, 14, 28, 90, and 120

Title

Quality of Life (QOL) as measured by the PROMIS-29 - Sleep

Description

The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.

Time Frame

Day 7, 14, 28, 90, and 120

Title

Time Unwell in Days as Measured by the Symptom and Clinical Event Scale

Description

Time Frame

Up to 14 days

Title

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

Description

The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.

Time Frame

Up to 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanna Naggie, MD

Organizational Affiliation

Duke Clinical Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adrian Hernandez, MD

Organizational Affiliation

Duke Clinical Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chandler Regional Medical Center

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Lamb Health, LLC

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85298

Country

United States

Facility Name

First Care Medical Clinic

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85203

Country

United States

Facility Name

Trident Health Center

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85382

Country

United States

Facility Name

University of Arkansas Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Hoag Memorial Hospital Presbyterian

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Assuta Family Medical Group APMC

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Stanford

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Olive View - UCLA Medical Center

City

Sylmar

State/Province

California

ZIP/Postal Code

91342

Country

United States

Facility Name

Doctors Medical Group of Colorado Springs, P.C.

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80917

Country

United States

Facility Name

Pine Ridge Family Medicine Inc.

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80924

Country

United States

Facility Name

Tabitha B. Fortt, M.D., LLC

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

George Washington University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Arena Medical Group

City

Deerfield Beach

State/Province

Florida

ZIP/Postal Code

33441

Country

United States

Facility Name

Lupus Foundation of Gainesville

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32606

Country

United States

Facility Name

University of Florida Health

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Facility Name

L and A Morales Healthcare, Inc

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

University of Florida-JAX-ASCENT

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

AMRON Vitality and Wellness Center, LLC

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32244

Country

United States

Facility Name

Sunshine Walk In Clinic

City

Lake Mary

State/Province

Florida

ZIP/Postal Code

32746

Country

United States

Facility Name

Lakeland Regional Medical Center

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

The Angel Medical Research Corporation

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Jackson Memorial Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Well Pharma Medical Research

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Innovation Clinical Trials Inc.

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Lice Source Services Plantation

City

Plantation

State/Province

Florida

ZIP/Postal Code

33313

Country

United States

Facility Name

Premier Health

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33707

Country

United States

Facility Name

Tallahassee Memorial Hospital

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Tampa General Hospital

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

UF Health Precision Health Research

City

The Villages

State/Province

Florida

ZIP/Postal Code

32159

Country

United States

Facility Name

Morehouse School of Medicine

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30310

Country

United States

Facility Name

Emory Healthcare

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Essential Medical Care, Inc.

City

College Park

State/Province

Georgia

ZIP/Postal Code

30349

Country

United States

Facility Name

Clincept, LLC

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

HOPE Clinical Research and Wellness

City

Conyers

State/Province

Georgia

ZIP/Postal Code

30094

Country

United States

Facility Name

David Kavtaradze MD, Inc.

City

Cordele

State/Province

Georgia

ZIP/Postal Code

31015

Country

United States

Facility Name

Elite Family Practice

City

Douglasville

State/Province

Georgia

ZIP/Postal Code

30134

Country

United States

Facility Name

Christ the King Health Care, P.C.

City

Loganville

State/Province

Georgia

ZIP/Postal Code

30052

Country

United States

Facility Name

Miller Family Practice, LLC

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Olivo Wellness Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60618

Country

United States

Facility Name

NorthShore Medical Group

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Advanced Medical Care, Ltd

City

Lake Zurich

State/Province

Illinois

ZIP/Postal Code

60047

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Franciscan Health Michigan City

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Del Pilar Medical and Urgent Care

City

Mishawaka

State/Province

Indiana

ZIP/Postal Code

46545

Country

United States

Facility Name

University of Kansas - Wichita

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

A New Start II, LLC

City

Central City

State/Province

Kentucky

ZIP/Postal Code

42330

Country

United States

Facility Name

Christus Saint Frances Hospita

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Facility Name

University Medical Center- New Orleans

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Ochsner Clinic Foundation

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287-1900

Country

United States

Facility Name

Jadestone Clinical Research, LLC

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20855

Country

United States

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Health Quality Primary Care

City

Lawrence

State/Province

Massachusetts

ZIP/Postal Code

01843

Country

United States

Facility Name

University of Massachusetts Medical School

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Ananda Medical Clinic

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48124

Country

United States

Facility Name

GFC of Southeastern Michigan, PC

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Romancare Health Services

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48206

Country

United States

Facility Name

Essentia Health

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

University of Missouri - Columbia

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Comprehensive Pain Management and Endocrinology

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Focus Clinical Research Solutions

City

Bayonne

State/Province

New Jersey

ZIP/Postal Code

07002

Country

United States

Facility Name

Raritan Bay Primary Care & Cardiology Associates

City

Matawan

State/Province

New Jersey

ZIP/Postal Code

07747

Country

United States

Facility Name

G&S Medical Associates, LLC

City

Paterson

State/Province

New Jersey

ZIP/Postal Code

07514

Country

United States

Facility Name

Mediversity Healthcare

City

Turnersville

State/Province

New Jersey

ZIP/Postal Code

08012

Country

United States

Facility Name

Christus St. Vincent Regional Medical Center

City

Santa Fe

State/Province

New Mexico

ZIP/Postal Code

87505

Country

United States

Facility Name

Geriatrics and Medical Associates

City

Clinton

State/Province

New York

ZIP/Postal Code

13323

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Spinal Pain and Medical Rehab, PC

City

Yonkers

State/Province

New York

ZIP/Postal Code

10701

Country

United States

Facility Name

Vaidya MD PLLC

City

Clayton

State/Province

North Carolina

ZIP/Postal Code

27520

Country

United States

Facility Name

Maria Medical Center, PLLC

City

Dunn

State/Province

North Carolina

ZIP/Postal Code

28334

Country

United States

Facility Name

Duke Clinical Research Institute

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27701

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Lapis Clinical Research

City

Mooresville

State/Province

North Carolina

ZIP/Postal Code

28117

Country

United States

Facility Name

Superior Clinical Research

City

Smithfield

State/Province

North Carolina

ZIP/Postal Code

27577

Country

United States

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27151

Country

United States

Facility Name

Diabetes and Endocrinology Assoc. of Stark County

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

TriHealth, Inc

City

Montgomery

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

The Heart and Medical Center

City

Durant

State/Province

Oklahoma

ZIP/Postal Code

74701

Country

United States

Facility Name

Hugo Medical clinic

City

Hugo

State/Province

Oklahoma

ZIP/Postal Code

74743

Country

United States

Facility Name

Ascension St. John

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

Bucks County Clinical Research

City

Morrisville

State/Province

Pennsylvania

ZIP/Postal Code

19067

Country

United States

Facility Name

Temple University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

Facility Name

Clinical Trials Center of Middle TN

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37067

Country

United States

Facility Name

Rapha Family Wellness

City

Hendersonville

State/Province

Tennessee

ZIP/Postal Code

37075

Country

United States

Facility Name

Medical Specialists of Knoxville

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37938

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Express Family Clinic

City

Allen

State/Province

Texas

ZIP/Postal Code

75013

Country

United States

Facility Name

DHR Health Institute for Research

City

Edinburg

State/Province

Texas

ZIP/Postal Code

78539

Country

United States

Facility Name

Texas Tech University Health Sciences Center

City

El Paso

State/Province

Texas

ZIP/Postal Code

79905

Country

United States

Facility Name

Brooke Army Medical Center

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Facility Name

Texas Health Physicians Group

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

Highlands Medical Associates, P.A.

City

Highlands

State/Province

Texas

ZIP/Postal Code

77562

Country

United States

Facility Name

University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Family Practice Doctors P.A.

City

Humble

State/Province

Texas

ZIP/Postal Code

77338

Country

United States

Facility Name

Texas Health Physicians Group

City

Irving

State/Province

Texas

ZIP/Postal Code

75039

Country

United States

Facility Name

Kintex Group Texas LLC, DBA Activian Clinical Research

City

Kingwood

State/Province

Texas

ZIP/Postal Code

77339

Country

United States

Facility Name

University Diagnostics and Treatment Clinic

City

Pasadena

State/Province

Texas

ZIP/Postal Code

77504

Country

United States

Facility Name

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Jeremy W. Szeto, D.O., P.A.

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

University of Texas Rio Grande Valley

City

Weslaco

State/Province

Texas

ZIP/Postal Code

78596

Country

United States

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Providence Medical Research Center

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We will share this data after it has been de-identified. We will share data beginning around 6 months after publication and for up to 36 months afterward. Access will only be shared with those who have obtained prior IRB approval to be able to access this data.

IPD Sharing Time Frame

Up to 36 months after publication

IPD Sharing Access Criteria

Interested investigators will need to seek prior IRB approval before access to any data is granted.

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Covid19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial