Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05736861
Status:
COMPLETED
Last Update Posted:
2023-06-13
First Post:
2023-02-17
Brief Title:
ACTIV-6 COVID-19 Study of Repurposed Medications - Arm A Ivermectin 400
Sponsor:
Susanna Naggie MD
Organization:
Duke University
Study Overview
Official Title:
ACTIV-6 COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness of repurposed medications study drugs 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 clinicaltrialsgov and will be updated with the activation of any new drug arms This protocol was originally registered under NCT04885530 Per recent guidance on reporting master protocol research programs MPRPs a separate record for Arm A was created
Prior and current drug arms are listed on clinicaltrialsgov and will be updated with the activation of any new drug arms This protocol was originally registered under NCT04885530 Per recent guidance on reporting master protocol research programs MPRPs a separate record for Arm A was created
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 andor 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 11 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 drugplacebo 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
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 andor 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 11 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 drugplacebo 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3U24TR001608-05W1 | NIH | None | httpsreporternihgovquickSearch3U24TR001608-05W1 |