Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05780424
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2023-03-20
Brief Title:
BRII-196BRII-198 for Inpatients With COVID-19 An ACTIV-3TICO Treatment Trial
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Adaptive Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 Trial H3 BRII-196BRII-198
Status:
COMPLETED
Status Verified Date:
2024-02
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:
This study looks at the safety and effectiveness of BRII-196BRII-198 in treating COVID-19 in people who have been hospitalized with the infection Participants in the study will be treated with either BRII-196BRII-198 plus current standard of care SOC or with placebo plus current SOC This is ACTIV-3TICO Treatment Trial H3
Detailed Description:
This is a treatment trial of the ACTIV-3TICO master protocol NCT04501978 to evaluate the safety and efficacy of BRII-196BRII-198 in hospitalized patients infected with COVID-19
This is a randomized blinded controlled sub-study of BRII-196BRII-198 plus current standard of care SOC against placebo plus current SOC The placebo arm may be shared across other sub-studies of the ACTIV-3TICO master protocol When more than one drug is being tested at the same time participants will be randomly allocated to treatments or placebo
Randomization will be stratified by study site pharmacy and disease severity There are 2 disease severity strata Participants without organ failure severity stratum 1 and participants with organ failure severity stratum 2
An independent Data and Safety Monitoring Board DSMB will regularly review interim analyses and summarize safety and efficacy outcomes The pace of enrollment with be initially restricted and there will be an early review of safety data by the DSMB At the outset of the trial only participants in disease severity stratum 1 will be enrolled This will continue until approximately 300 participants are enrolled and followed for 5 days The exact number will vary according to the speed of enrollment and the timing of DSMB meetings Prior to expanding enrollment to also include patients in disease severity stratum 2 safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5
If BRII-196BRII-198 passes the futility assessment enrollment of participants will be expanded seamlessly and without any data unblinding to include participants in disease severity stratum 2 as well as those in disease severity stratum 1 Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit harm or futility for the investigational agent Participants will be followed for 18 months following randomization
This trial will be conducted in several hundred clinical sites Participating sites are affiliated with networks funded by the United States National Institutes of Health NIH and the US Department of Veterans Affairs
This is a randomized blinded controlled sub-study of BRII-196BRII-198 plus current standard of care SOC against placebo plus current SOC The placebo arm may be shared across other sub-studies of the ACTIV-3TICO master protocol When more than one drug is being tested at the same time participants will be randomly allocated to treatments or placebo
Randomization will be stratified by study site pharmacy and disease severity There are 2 disease severity strata Participants without organ failure severity stratum 1 and participants with organ failure severity stratum 2
An independent Data and Safety Monitoring Board DSMB will regularly review interim analyses and summarize safety and efficacy outcomes The pace of enrollment with be initially restricted and there will be an early review of safety data by the DSMB At the outset of the trial only participants in disease severity stratum 1 will be enrolled This will continue until approximately 300 participants are enrolled and followed for 5 days The exact number will vary according to the speed of enrollment and the timing of DSMB meetings Prior to expanding enrollment to also include patients in disease severity stratum 2 safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5
If BRII-196BRII-198 passes the futility assessment enrollment of participants will be expanded seamlessly and without any data unblinding to include participants in disease severity stratum 2 as well as those in disease severity stratum 1 Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit harm or futility for the investigational agent Participants will be followed for 18 months following randomization
This trial will be conducted in several hundred clinical sites Participating sites are affiliated with networks funded by the United States National Institutes of Health NIH and the US Department of Veterans Affairs
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