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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
Sponsored by
Susanna Naggie, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Sites / Locations

  • Chandler Regional Medical Center
  • Lamb Health, LLC
  • First Care Medical Clinic
  • Trident Health Center
  • University of Arkansas Medical Sciences
  • Hoag Memorial Hospital Presbyterian
  • Assuta Family Medical Group APMC
  • Stanford
  • Olive View - UCLA Medical Center
  • Doctors Medical Group of Colorado Springs, P.C.
  • Pine Ridge Family Medicine Inc.
  • Tabitha B. Fortt, M.D., LLC
  • George Washington University Hospital
  • Arena Medical Group
  • Lupus Foundation of Gainesville
  • University of Florida Health
  • L and A Morales Healthcare, Inc
  • University of Florida-JAX-ASCENT
  • AMRON Vitality and Wellness Center, LLC
  • Sunshine Walk In Clinic
  • Lakeland Regional Medical Center
  • The Angel Medical Research Corporation
  • Jackson Memorial Hospital
  • University of Miami
  • Well Pharma Medical Research
  • Innovation Clinical Trials Inc.
  • Lice Source Services Plantation
  • Premier Health
  • Tallahassee Memorial Hospital
  • Tampa General Hospital
  • UF Health Precision Health Research
  • Morehouse School of Medicine
  • Emory Healthcare
  • Essential Medical Care, Inc.
  • Clincept, LLC
  • HOPE Clinical Research and Wellness
  • David Kavtaradze MD, Inc.
  • Elite Family Practice
  • Christ the King Health Care, P.C.
  • Miller Family Practice, LLC
  • Rush University Medical Center
  • Olivo Wellness Medical Center
  • NorthShore Medical Group
  • Advanced Medical Care, Ltd
  • Loyola University Medical Center
  • Franciscan Health Michigan City
  • Del Pilar Medical and Urgent Care
  • University of Kansas - Wichita
  • A New Start II, LLC
  • Christus Saint Frances Hospita
  • University Medical Center- New Orleans
  • Ochsner Clinic Foundation
  • Johns Hopkins Hospital
  • Jadestone Clinical Research, LLC
  • Boston Medical Center
  • Health Quality Primary Care
  • University of Massachusetts Medical School
  • Ananda Medical Clinic
  • GFC of Southeastern Michigan, PC
  • Romancare Health Services
  • Essentia Health
  • University of Minnesota
  • University of Missouri - Columbia
  • Comprehensive Pain Management and Endocrinology
  • Focus Clinical Research Solutions
  • Raritan Bay Primary Care & Cardiology Associates
  • G&S Medical Associates, LLC
  • Mediversity Healthcare
  • Christus St. Vincent Regional Medical Center
  • Geriatrics and Medical Associates
  • Weill Cornell Medical College
  • Spinal Pain and Medical Rehab, PC
  • Vaidya MD PLLC
  • Maria Medical Center, PLLC
  • Duke Clinical Research Institute
  • Duke University Medical Center
  • Lapis Clinical Research
  • Superior Clinical Research
  • Wake Forest Baptist Health
  • Diabetes and Endocrinology Assoc. of Stark County
  • University of Cincinnati
  • TriHealth, Inc
  • The Heart and Medical Center
  • Hugo Medical clinic
  • Ascension St. John
  • Bucks County Clinical Research
  • Temple University Hospital
  • University of Pittsburgh
  • Medical University of South Carolina
  • Clinical Trials Center of Middle TN
  • Rapha Family Wellness
  • Medical Specialists of Knoxville
  • Vanderbilt University Medical Center
  • Express Family Clinic
  • DHR Health Institute for Research
  • Texas Tech University Health Sciences Center
  • Brooke Army Medical Center
  • Texas Health Physicians Group
  • Highlands Medical Associates, P.A.
  • University of Texas Health Science Center at Houston
  • Family Practice Doctors P.A.
  • Texas Health Physicians Group
  • Kintex Group Texas LLC, DBA Activian Clinical Research
  • University Diagnostics and Treatment Clinic
  • University of Texas Health Science Center at San Antonio
  • Jeremy W. Szeto, D.O., P.A.
  • University of Texas Rio Grande Valley
  • University of Virginia
  • Providence Medical Research Center

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.
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 28.
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.
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
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 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

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
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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
No
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 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.
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
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.
Time Frame
Day 7
Title
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
Description
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.
Time Frame
Day 14
Title
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28.
Description
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.
Time Frame
Day 28
Title
Quality of Life (QOL) as measured by the PROMIS-29 - Physical Function
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 physical function.
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
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 pain.
Time Frame
Day 7, 14, 28, 90, and 120
Title
Quality of Life (QOL) as measured by the PROMIS-29 - Depression
Description
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.
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
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.
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
No
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
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)

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