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History of Changes for Study: NCT04885530
ACTIV-6: COVID-19 Study of Repurposed Medications
Latest version (submitted August 19, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 11, 2021 None (earliest Version on record)
2 June 8, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 July 13, 2021 Arms and Interventions, Study Status, Contacts/Locations and Conditions
4 July 20, 2021 Arms and Interventions, Contacts/Locations and Study Status
5 August 26, 2021 Contacts/Locations and Study Status
6 October 31, 2021 Contacts/Locations and Study Status
7 December 9, 2021 Study Status and Contacts/Locations
8 December 21, 2021 Contacts/Locations and Study Status
9 March 22, 2022 Contacts/Locations, Arms and Interventions and Study Status
10 May 26, 2022 Contacts/Locations and Study Status
11 June 25, 2022 Outcome Measures, Study Status and Contacts/Locations
12 August 19, 2022 Arms and Interventions, Study Status and Outcome Measures
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Study NCT04885530
Submitted Date:  May 11, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: Pro00107921
Brief Title: ACTIV-6: COVID-19 Study of Repurposed Medications
Official Title: ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
Secondary IDs: 3U24TR001608-05W1 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: May 2021
Overall Status: Not yet recruiting
Study Start: May 2021
Primary Completion: December 2022 [Anticipated]
Study Completion: March 2023 [Anticipated]
First Submitted: April 30, 2021
First Submitted that
Met QC Criteria:
May 11, 2021
First Posted: May 13, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
May 11, 2021
Last Update Posted: May 13, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Susanna Naggie, MD
Responsible Party: Sponsor-Investigator
Investigator: Susanna Naggie, MD
Official Title: Associate Professor of Medicine
Affiliation: Duke University
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Vanderbilt University Medical Center
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
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.

Open or close this module Conditions
Conditions: Covid19
Keywords: SARS-CoV-2
COVID-19
Ivermectin
Placebo
Duke University Health System
Outcomes
Duke Clinical Research Institute
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Double-Blind, Placebo-Controlled, Randomized Trial
Number of Arms: 2
Masking: Double (Participant, Care Provider)
Allocation: Randomized
Enrollment: 15000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm A - Ivermectin

Ivermectin - 7-mg tablets

Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.

Drug: Ivermectin Tablets
Each participant will receive a total of twenty 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
Placebo Comparator: Arm A - Placebo

Placebo -7mg tablets

Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.

Drug: Ivermectin Tablets
Each participant will receive a total of twenty 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of hospitalizations as measured by patient reports.
[ Time Frame: Up to 14 days ]

2. Number of deaths as measured by patient reports
[ Time Frame: Up to 14 days ]

3. Number of symptoms as measured by patient reports
[ Time Frame: Up to 14 days ]

Secondary Outcome Measures:
1. Change in COVID Clinical Progression Scale
[ Time Frame: Up to 28 days ]

COVID Clinical Progression Scale is a scale of 0 to 8, with 0 being "No clinical or virological evidence of infection" to 8 being "death".
2. Number of hospitalizations as measured by patient reports
[ Time Frame: Up to 28 days ]

3. Number of deaths as measured by patient reports
[ Time Frame: Up to 28 days ]

4. Number of Symptom Resolutions as measured by patient reports
[ Time Frame: Up to 28 days ]

Symptom resolution, defined as first of at least three consecutive days without symptoms
5. Change in Quality of Life (QOL) as measured by the PROMIS-29
[ Time Frame: Baseline, Day 7, 14, 28, and 29 ]

The PROMIS-29 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.
6. Composite score of hospitalizations, urgent care visits, and emergency room visits as measured by patient reports
[ Time Frame: Up to 28 days ]

Open or close this module Eligibility
Minimum Age: 30 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Completed Informed Consent
  • Age ≥ 30 years old
  • Confirmed SARS-CoV-2 infection 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
Open or close this module Contacts/Locations
Central Contact Person: Allison DeLong
Telephone: 1-833-385-1880
Email: allison.hayes@duke.edu
Central Contact Backup: Kris Anderberg
Telephone: 1-833-385-1880
Email: kristin.anderberg@duke.edu
Study Officials: Susanna Naggie, MD
Principal Investigator
Duke Clinical Rsearch Institute
Locations: United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27701
Contact:Contact: Allison DeLong 919-668-6855 allison.hayes@duke.edu
Contact:Principal Investigator: Susanna Naggie, MD
Open or close this module IPDSharing
Plan to Share IPD: Yes
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.
Supporting Information:
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:
Up to 36 months after publication
Access Criteria:
Interested investigators will need to seek prior IRB approval before access to any data is granted.
URL:
Open or close this module References
Links:
Available IPD/Information:

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