Status:
COMPLETED
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
Lead Sponsor:
Sao Thai Duong Joint Stock Company
Collaborating Sponsors:
CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED
Conditions:
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 var...
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2022
Estimated Enrollment :
573 Patients enrolled
Trial Details
Trial ID
NCT05249777
Start Date
January 6 2022
End Date
September 10 2022
Last Update
September 21 2022
Active Locations (2)
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1
Traditional Medicine Institute in Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh, Vietnam
2
Hanoi Hospital of Traditional Medicine
Hà Nội, Vietnam