Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05249777
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2022-02-21
Brief Title:
A Phase III Randomised Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of TD0069 Capsule for Patients With Mild to Moderate COVID-19
Sponsor:
Sao Thai Duong Joint Stock Company
Organization:
Sao Thai Duong Joint Stock Company
Study Overview
Official Title:
A Phase III Randomised Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of TD0069 Capsule for Patients With Mild to Moderate COVID-19
Status:
COMPLETED
Status Verified Date:
2022-09
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:
The acute pneumonia pandemic caused by a new strain of corona virus 2019 namely as COVID-19 by the World Health Organization WHO is a pandemic caused by SARS-CoV-2 virus The reported symptoms vary from fever or chills cough shortness of breath to muscle aches headaches loss of taste or smell
The capsule TD0069 is a product based on the traditional medicine named Ren shen bai du san which is used to treat the cold conditions also known as the initial plague according to the theory of traditional medicine
The capsule TD0069 is a product based on the traditional medicine named Ren shen bai du san which is used to treat the cold conditions also known as the initial plague according to the theory of traditional medicine
Detailed Description:
The acute pneumonia pandemic caused by a new strain of corona virus 2019 namely as COVID-19 by the World Health Organization WHO is a pandemic caused by SARS-CoV-2 virus The reported symptoms have included but are not limited to fever or chills cough shortness of breath muscle aches headaches loss of taste or smell diarrhea dizziness sore throat abdominal pain anorexia and vomiting
The capsule TD0069 is a product based on the traditional prescription named Ren shen bai du san which is used to treat the cold conditions also known as the initial plague according to the theory of traditional medicine
The study compares between standard dose regimen of TD0069 combined with standard treatment in COVID-19 patients and only standard treatment in COVID-19 patients A sample size of 570 patients 380 in TD0069 arm and 190 in Placebo arm
All participants will be treated and followed up in 14-day period In case the participant meets the discharge criteria before 14 days discontinuing the study drug will be done at the discretion of the investigators
Firstly screening procedures occur at Day 1 Secondly periodic assessments are conducted daily from Day 2-14 Finally end-of-study assessments are conducted according to the study protocol
The capsule TD0069 is a product based on the traditional prescription named Ren shen bai du san which is used to treat the cold conditions also known as the initial plague according to the theory of traditional medicine
The study compares between standard dose regimen of TD0069 combined with standard treatment in COVID-19 patients and only standard treatment in COVID-19 patients A sample size of 570 patients 380 in TD0069 arm and 190 in Placebo arm
All participants will be treated and followed up in 14-day period In case the participant meets the discharge criteria before 14 days discontinuing the study drug will be done at the discretion of the investigators
Firstly screening procedures occur at Day 1 Secondly periodic assessments are conducted daily from Day 2-14 Finally end-of-study assessments are conducted according to the study protocol
Study Oversight
Has Oversight DMC:
None
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?:
None