Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04518410
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2020-08-17
Brief Title:
ACTIV-2 A Study for Outpatients With COVID-19
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Adaptive Platform Treatment Trial for Outpatients With COVID-19 Adapt Out COVID
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Drug studies often look at the effect one or two drugs have on a medical condition and involve one company There is currently an urgent need for one study to efficiently test multiple drugs from more than one company in people who have tested positive for COVID-19 but who do not currently need hospitalization This could help prevent disease progression to more serious symptoms and complications and spread of COVID-19 in the community
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients In Phase II participants in the study will be treated with either a study drug or with placebo In protocol version 70 participants in Phase III of the study will be treated with either a study drug or active comparator drug Participants assigned to the bamlanivimab agentplacebo arm and will have 28 days of intensive follow-up following study drug administration followed by limited follow-up through 24 weeks in phase II and in phase III All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up followed by limited follow-up through 72 weeks in phase II and phase III Additional study visits may be required depending on the agent
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients In Phase II participants in the study will be treated with either a study drug or with placebo In protocol version 70 participants in Phase III of the study will be treated with either a study drug or active comparator drug Participants assigned to the bamlanivimab agentplacebo arm and will have 28 days of intensive follow-up following study drug administration followed by limited follow-up through 24 weeks in phase II and in phase III All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up followed by limited follow-up through 72 weeks in phase II and phase III Additional study visits may be required depending on the agent
Detailed Description:
This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection or directly enhancing viral control in order to limit disease progression
The study includes both infused and non-infused agents and is a randomized controlled platform that allows agents to be added and dropped during the course of the study for efficient phase II and phase III testing of new agents within the same trial infrastructure
Version 7 of the protocol provided for blinded phase II evaluation of an investigational agent for superiority to placebo among participants at lower risk of progression to hospitalization or death regardless of the mode of administration of the agent
Agents that graduate to phase III after initiation of the protocol version will be evaluated in persons at higher risk for progression to hospitalization or death for non-inferiority to an active comparator monoclonal antibody cocktail of casirivimab plus imdevimab REGEN-COV Regeneron This active comparator has been shown to be effective in this population in preventing hospitalization or death When two or more agents are being evaluated in the same phase of the study the trial design includes sharing of the control group placebo in phase II and active comparator in phase III for efficient evaluation of each agent
Investigational agents will be approved by the Trial Oversight Committee TOC for phase II evaluation based on the presence of in vitro data demonstrating promise as anti-SARS-CoV-2 therapeutics in pre-clinical testing and for which there are suitable pharmacokinetics and safety data from phase I testing or through clinical or research testing for a different indication and agent availability Investigational agents will be included in phase III evaluation based on agent entry criteria for phase III as outlined in the protocol or by TOC approval based on data available outside ACTIV-2
The study includes both infused and non-infused agents and is a randomized controlled platform that allows agents to be added and dropped during the course of the study for efficient phase II and phase III testing of new agents within the same trial infrastructure
Version 7 of the protocol provided for blinded phase II evaluation of an investigational agent for superiority to placebo among participants at lower risk of progression to hospitalization or death regardless of the mode of administration of the agent
Agents that graduate to phase III after initiation of the protocol version will be evaluated in persons at higher risk for progression to hospitalization or death for non-inferiority to an active comparator monoclonal antibody cocktail of casirivimab plus imdevimab REGEN-COV Regeneron This active comparator has been shown to be effective in this population in preventing hospitalization or death When two or more agents are being evaluated in the same phase of the study the trial design includes sharing of the control group placebo in phase II and active comparator in phase III for efficient evaluation of each agent
Investigational agents will be approved by the Trial Oversight Committee TOC for phase II evaluation based on the presence of in vitro data demonstrating promise as anti-SARS-CoV-2 therapeutics in pre-clinical testing and for which there are suitable pharmacokinetics and safety data from phase I testing or through clinical or research testing for a different indication and agent availability Investigational agents will be included in phase III evaluation based on agent entry criteria for phase III as outlined in the protocol or by TOC approval based on data available outside ACTIV-2
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 |
|---|---|---|---|
| 38742 | OTHER | DAIDS-ES | None |