Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04709328
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-03-29
First Post:
2021-01-13
Brief Title:
To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19
Sponsor:
Sinocelltech Ltd
Organization:
Sinocelltech Ltd
Study Overview
Official Title:
An Adaptive Randomized Double-blinded Placebo-controlled Phase IIIII Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in High-Risk Outpatients With COVID-19 MAOP3 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-03
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:
MAOP3
Brief Summary:
The study is a multicenter adaptive randomized double-blinded and placebo-controlled Phase IIIII clinical trial It will be conducted at selected investigational sites globally The study is comprised of 2 parts
Detailed Description:
The study is a multicenter adaptive randomized double-blinded and placebocontrolled Phase IIIII trial It will be conducted globally The study will evaluate the efficacy and safety of SCTA01 in high-risk outpatients with COVID-19The primary objective of the study is to evaluate the clinical efficacy rate among study group SCTA01 standard of care SOC and control group placebo SOC up to Day 29
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