Efficacy of KOVIR Capsule in the Combination Regimen With Background Treatment in COVID-19 Patients
Primary Purpose
COVID-19
Status
Unknown status
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
KOVIR capsule combined with background treatment
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged from 18-65, Vietnamese nationality
- Participants diagnosed with Positive result of SARS-CoV-2 using real time RT-PCR test, Ct value <30 (equivalent to viral load > 3log)
- Voluntary participation in the study by signing an informed consent
- Ability to adhere to treatment according to the investigator's assessment
Exclusion Criteria:
- Symptoms of severe upper and lower respiratory tract infections such as dyspnea, SpO2<93%.
Acute reduction of ventilation function of respiratory apparatus and/or respiration function of the lung in any of the following three groups:
- Respiratory distress due to hypoxemia with PaO2 less than 60mmHg when breathing room air.
- Respiratory distress due to hypercapnia with PaCO2 above 50mmHg
- Mixed respiratory distress accompanied by both a decrease in PaO2 and an increase in PaCO2
- Allergy/intolerance to any component of the study drug.
- Inability to administer medicine.
- Severe pneumonia as assessed by the investigator.
- Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators.
Sites / Locations
- Traditional Medicine Institute in Ho Chi Minh City
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
KOVIR
NON-KOVIR
Arm Description
Standard dose, 3 capsules/time x 3 times/day x 14 days combined with background treatment
Only background treatment
Outcomes
Primary Outcome Measures
Mean duration of clinical symptoms
Mean time from baseline to no clinical symptom of COVID-19
Number of participants with respiratory distress complications requiring treatment
Occurrence of symptoms of respiratory distress complications requiring treatment
Change in the severity of daily symptoms
Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Frequency and severity of Study drug-related adverse events, adverse events leading to study termination, serious adverse events (SAE)
Secondary Outcome Measures
Full Information
NCT ID
NCT05044650
First Posted
September 13, 2021
Last Updated
January 25, 2022
Sponsor
Sao Thai Duong Joint Stock Company
Collaborators
Big Leap Clinical Research Joint Stock Company
1. Study Identification
Unique Protocol Identification Number
NCT05044650
Brief Title
Efficacy of KOVIR Capsule in the Combination Regimen With Background Treatment in COVID-19 Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sao Thai Duong Joint Stock Company
Collaborators
Big Leap Clinical Research Joint Stock Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned randomly 7:3 to either KOVIR group or Non-KOVIR group respectively.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KOVIR
Arm Type
Experimental
Arm Description
Standard dose, 3 capsules/time x 3 times/day x 14 days combined with background treatment
Arm Title
NON-KOVIR
Arm Type
No Intervention
Arm Description
Only background treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
KOVIR capsule combined with background treatment
Intervention Description
KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
Primary Outcome Measure Information:
Title
Mean duration of clinical symptoms
Description
Mean time from baseline to no clinical symptom of COVID-19
Time Frame
up to 14 days
Title
Number of participants with respiratory distress complications requiring treatment
Description
Occurrence of symptoms of respiratory distress complications requiring treatment
Time Frame
up to 14 days
Title
Change in the severity of daily symptoms
Description
Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe
Time Frame
up to 14 days
Title
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Description
Frequency and severity of Study drug-related adverse events, adverse events leading to study termination, serious adverse events (SAE)
Time Frame
up to 30 days after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, aged from 18-65, Vietnamese nationality
Participants diagnosed with Positive result of SARS-CoV-2 using real time RT-PCR test, Ct value <30 (equivalent to viral load > 3log)
Voluntary participation in the study by signing an informed consent
Ability to adhere to treatment according to the investigator's assessment
Exclusion Criteria:
Symptoms of severe upper and lower respiratory tract infections such as dyspnea, SpO2<93%.
Acute reduction of ventilation function of respiratory apparatus and/or respiration function of the lung in any of the following three groups:
Respiratory distress due to hypoxemia with PaO2 less than 60mmHg when breathing room air.
Respiratory distress due to hypercapnia with PaCO2 above 50mmHg
Mixed respiratory distress accompanied by both a decrease in PaO2 and an increase in PaCO2
Allergy/intolerance to any component of the study drug.
Inability to administer medicine.
Severe pneumonia as assessed by the investigator.
Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thi Hong Van Nguyen, MSc
Phone
(+84)916451269
Email
vannh@thaiduong.com.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loc Huynh, SL II., MD.
Organizational Affiliation
Traditional Medicine Institute in Ho Chi Minh City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Traditional Medicine Institute in Ho Chi Minh City
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huong Dinh, SL II., MD.
Phone
(+84)983699665
Email
dinhlanhuonghmu@gmail.com
First Name & Middle Initial & Last Name & Degree
Loc Huynh, SL II., MD.
First Name & Middle Initial & Last Name & Degree
Lan Truong, PhD., MD.
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of KOVIR Capsule in the Combination Regimen With Background Treatment in COVID-19 Patients
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