Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT05689034
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2023-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adult Participants With COVID-19 Who Are at Increased Risk of Progressing to Severe Illness
Status:
RECRUITING
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:
To investigate whether treatment with Azvudine reduces the risk of severe illness or death in patients who are at a potential risk of progressing to severe COVID-19 infection.
Detailed Description:
The study is designed as a randomized, parallel, double-blind, placebo-controlled trial, in which all participants will be randomized to a test group or control group in a 1:1 ratio.
The test group will be given Azvudine in combination with conventional therapy excluding anti-viral therapy and observed for efficacy. The control group will be given placebo in combination with conventional therapy excluding anti-viral therapy and observed for efficacy.
Test Group will recruit 548 participants who will be given Azvudine + conventional therapy other than antiviral\*5 mg/day, oral, up to 7 days (1 mg/tablet).
Control Group will recruit 548 who will be given Placebo + conventional therapy other than antiviral\* 5 tablets/day, oral, up to 7 days.
The test group will be given Azvudine in combination with conventional therapy excluding anti-viral therapy and observed for efficacy. The control group will be given placebo in combination with conventional therapy excluding anti-viral therapy and observed for efficacy.
Test Group will recruit 548 participants who will be given Azvudine + conventional therapy other than antiviral\*5 mg/day, oral, up to 7 days (1 mg/tablet).
Control Group will recruit 548 who will be given Placebo + conventional therapy other than antiviral\* 5 tablets/day, oral, up to 7 days.
Study Oversight
Has Oversight DMC:
True
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?: