Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05044650
Status:
UNKNOWN
Last Update Posted:
2022-02-04
First Post:
2021-09-13
Brief Title:
Efficacy of KOVIR Capsule in the Combination Regimen With Background Treatment in COVID-19 Patients
Sponsor:
Sao Thai Duong Joint Stock Company
Organization:
Sao Thai Duong Joint Stock Company
Study Overview
Official Title:
A Study to Evaluate the Efficacy of KOVIR Capsule TD0069 in the Combination Regimen With Background Treatment in COVID-19 Patients Without Symptoms of Acute Respiratory Distress
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
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 KOVIR 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 KOVIR 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 KOVIR 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 KOVIR combined with background treatment in COVID-19 patients and only background treatment in COVID-19 patients The study will enroll 700 participants to KOVIR group and 300 participant to Non-KOVIR group
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
Screening procedures occur at Day 1 Periodic assessments are conducted daily from Day 2-14 Finally End of study visit is conducted
The capsule KOVIR 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 KOVIR combined with background treatment in COVID-19 patients and only background treatment in COVID-19 patients The study will enroll 700 participants to KOVIR group and 300 participant to Non-KOVIR group
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
Screening procedures occur at Day 1 Periodic assessments are conducted daily from Day 2-14 Finally End of study visit is conducted
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