Back to resultsA 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
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 3
Locations
Vietnam
Study Type
Interventional
Intervention
TD0069 hard capsule
TD0069 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Human, age ranged from 18 to 65 years old, Vietnamese nationality.
- Confirmed diagnosis with a positive test for SARS-CoV-2 by real-time RT-PCR.
- Patients with mild and moderate Covid-19 disease according to the classification of clinical severity of SARS CoV2 of the Ministry of Health (No. 4689/QĐ-BYT Decision dated October 6, 2021 of the Ministry of Health about promulgating guidelines for diagnosis and treatment Covid-19 ): patient is awake, breathing rate ≤ 25 times/min, SpO2 ≥ 94% when breathing room air, and may have difficulty breathing when exertion.
- Provision of signed informed consent.
- Being able to comply with study procedures and treatment, in the opinion of the investigator.
- Patients with at least 01 of 11 main symtoms of Covid-19
Exclusion Criteria:
- Symptoms of severe upper and lower respiratory tract infections (as defined by WHO)1 such as dyspnea, SpO2 < 94%.
Patients with acute respiratory distress in any of the following groups:
- Respiratory failure due to hypoxemia when PaO2 was less than 60mmHg with room air.
- Respiratory failure due to hypercapnia when PaCO2 was above 50mmHg.
- Mixed respiratory failure due to the combination of hypoxemia and hypercapnia.
- Allergy/intolerance to any ingredient of the investigational products.
- Patients who are not able to orally use the investigational products.
- Patients who have been treated with corticoid at the screening.
- Participants who were not able to comply with study procedures and treatment, in the opinion of the investigator.
Sites / Locations
- Traditional Medicine Institute in Ho Chi Minh City
- Hanoi Hospital of Traditional Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TD0069
Placebo
Arm Description
Standard dose, 3 capsules/time x 3 times/day x 14 days before breakfast, lunch, and dinner combined with standard treatment.
Standard dose, 3 capsules/time x 3 times/day x 14 days before breakfast, lunch, and dinner combined with standard treatment
Outcomes
Primary Outcome Measures
The rate of patients with serious diseases/conditions related to Covid-19
Severe progression within 28 days of randomization, including occurrence of any 1 of the following events: Acute respiratory distress syndrome (ARDS) with high-flow nasal cannula oxygen therapy (HFNC) and invasive mechanical ventilation therapy, sepsis, septic shock , multiple organ failure requiring intensive care (ICU), other critical conditions, and death
Daily symptoms improvement
Symptom severity was assessed in accordance with the Covid-19 symptom assessment questionnaire of National Early Warning Score. The higher patient's score, the more severe symtoms.
Time to clinical symptom resolution
Mean time from randomization to symptom resolution in terms of general, cardiovascular, respiratory, digestive, musculoskeletal, neurological, and dermatological symptoms
The rate and severity grade of adverse events related to the investigational product
Absolute number of immediate adverse events classified by severity level Percentages were calculated as the total number of immediate adverse events classified by severity level divided by the total number of subjects.
Secondary Outcome Measures
The rate of Covid-19 diseases according to traditional medicine
Covid-19 diseases according to traditional medicine
Time to symptom resolution of Covid-19 diseases according to traditional medicine
Mean time from randomization to symptom resolution of Covid-19 diseases according to traditional medicine
The length of hospital stay
Date of discharge minus date of admission
The rate of Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
The proportion of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo) at day 5, day 9, day 14 after randomization.
The quality of life at day 0, day 7, day 14, and day 28
Quality of life score accordance with EQ-5D-5L questionnaire table
Full Information
NCT ID
NCT05249777
First Posted
February 21, 2022
Last Updated
September 19, 2022
Sponsor
Sao Thai Duong Joint Stock Company
Collaborators
CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED
1. Study Identification
Unique Protocol Identification Number
NCT05249777
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
September 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sao Thai Duong Joint Stock Company
Collaborators
CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED
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 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.
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
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Study subjects are randomized in a 2:1 ratio to 14 days treatment with TD0069 (3 capsules x 3 times/day) or Placebo (3 capsules x 3 times/day) based on a randomization block size of 6.
Masking
ParticipantInvestigator
Masking Description
Blinding is performed by the same appearance of TD0069 and placebo. The request for unblinding is done in accordance with the study protocol in cases of SAEs with the request of the investigators.
Allocation
Randomized
Enrollment
573 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TD0069
Arm Type
Experimental
Arm Description
Standard dose, 3 capsules/time x 3 times/day x 14 days before breakfast, lunch, and dinner combined with standard treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Standard dose, 3 capsules/time x 3 times/day x 14 days before breakfast, lunch, and dinner combined with standard treatment
Intervention Type
Drug
Intervention Name(s)
TD0069 hard capsule
Other Intervention Name(s)
Sunkovir
Intervention Description
TD0069 hard capsule (800 ± 7.5% mg/capsule) contains 600 mg fine powder of mixed herbal medicines and 200 mg excipients.
Intervention Type
Drug
Intervention Name(s)
TD0069 Placebo
Other Intervention Name(s)
Placebo
Intervention Description
TD0069 placebo (800 ± 7.5% mg/capsule) contains excipients
Primary Outcome Measure Information:
Title
The rate of patients with serious diseases/conditions related to Covid-19
Description
Severe progression within 28 days of randomization, including occurrence of any 1 of the following events: Acute respiratory distress syndrome (ARDS) with high-flow nasal cannula oxygen therapy (HFNC) and invasive mechanical ventilation therapy, sepsis, septic shock , multiple organ failure requiring intensive care (ICU), other critical conditions, and death
Time Frame
up to 28 days
Title
Daily symptoms improvement
Description
Symptom severity was assessed in accordance with the Covid-19 symptom assessment questionnaire of National Early Warning Score. The higher patient's score, the more severe symtoms.
Time Frame
up to 14 days
Title
Time to clinical symptom resolution
Description
Mean time from randomization to symptom resolution in terms of general, cardiovascular, respiratory, digestive, musculoskeletal, neurological, and dermatological symptoms
Time Frame
up to 14 days
Title
The rate and severity grade of adverse events related to the investigational product
Description
Absolute number of immediate adverse events classified by severity level Percentages were calculated as the total number of immediate adverse events classified by severity level divided by the total number of subjects.
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
The rate of Covid-19 diseases according to traditional medicine
Description
Covid-19 diseases according to traditional medicine
Time Frame
up to 14 days
Title
Time to symptom resolution of Covid-19 diseases according to traditional medicine
Description
Mean time from randomization to symptom resolution of Covid-19 diseases according to traditional medicine
Time Frame
up to 14 days
Title
The length of hospital stay
Description
Date of discharge minus date of admission
Time Frame
up to 14 days
Title
The rate of Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
Description
The proportion of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo) at day 5, day 9, day 14 after randomization.
Time Frame
Day 5, day 7, day 9, and day 14
Title
The quality of life at day 0, day 7, day 14, and day 28
Description
Quality of life score accordance with EQ-5D-5L questionnaire table
Time Frame
Day 0, day 7, day 14, and day 28
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:
Human, age ranged from 18 to 65 years old, Vietnamese nationality.
Confirmed diagnosis with a positive test for SARS-CoV-2 by real-time RT-PCR.
Patients with mild and moderate Covid-19 disease according to the classification of clinical severity of SARS CoV2 of the Ministry of Health (No. 4689/QĐ-BYT Decision dated October 6, 2021 of the Ministry of Health about promulgating guidelines for diagnosis and treatment Covid-19 ): patient is awake, breathing rate ≤ 25 times/min, SpO2 ≥ 94% when breathing room air, and may have difficulty breathing when exertion.
Provision of signed informed consent.
Being able to comply with study procedures and treatment, in the opinion of the investigator.
Patients with at least 01 of 11 main symtoms of Covid-19
Exclusion Criteria:
Symptoms of severe upper and lower respiratory tract infections (as defined by WHO)1 such as dyspnea, SpO2 < 94%.
Patients with acute respiratory distress in any of the following groups:
Respiratory failure due to hypoxemia when PaO2 was less than 60mmHg with room air.
Respiratory failure due to hypercapnia when PaCO2 was above 50mmHg.
Mixed respiratory failure due to the combination of hypoxemia and hypercapnia.
Allergy/intolerance to any ingredient of the investigational products.
Patients who are not able to orally use the investigational products.
Patients who have been treated with corticoid at the screening.
Participants who were not able to comply with study procedures and treatment, in the opinion of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loc Huynh Nguyen, SL II., MD.
Organizational Affiliation
Traditional Medicine Institute in Ho Chi Minh City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lan Truong Thi Ngoc, PhD., 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
State/Province
Ho Chi Minh
Country
Vietnam
Facility Name
Hanoi Hospital of Traditional Medicine
City
Ha Noi
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
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
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