Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-26 @ 7:47 AM
Study NCT ID:
NCT05279235
Status:
TERMINATED
Last Update Posted:
2023-02-08
First Post:
2022-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of JT001 (VV116) Compared With Favipiravir
Sponsor:
Shanghai Vinnerna Biosciences Co., Ltd.
Organization:
Study Overview
Official Title:
A Multi-center, Double-blinded, Randomized, Phase III Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Favipiravir in Participants With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Development strategy adjustment
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 efficacy and safety of JT001 (VV116) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe COVID-19.
Detailed Description:
Screening Interested participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.
The investigator will review symptoms, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility.
Treatment and Assessment Period
This is the general sequence of events during the 29-day treatment and assessment period:
* Complete baseline procedures and sample collection
* Participants are randomized to an intervention group
* Participants receive study intervention (Q12H X 5 days), and
* Complete all safety monitoring.
* Blood samples collection
The investigator will review symptoms, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility.
Treatment and Assessment Period
This is the general sequence of events during the 29-day treatment and assessment period:
* Complete baseline procedures and sample collection
* Participants are randomized to an intervention group
* Participants receive study intervention (Q12H X 5 days), and
* Complete all safety monitoring.
* Blood samples collection
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: