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

NCT ID: NCT05249777

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 573 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2022-09-10

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TD0069

Standard dose, 3 capsules/time x 3 times/day x 14 days before breakfast, lunch, and dinner combined with standard treatment.

Group Type: EXPERIMENTAL

TD0069 hard capsule

Intervention Type: DRUG

TD0069 hard capsule (800 ± 7.5% mg/capsule) contains 600 mg fine powder of mixed herbal medicines and 200 mg excipients.

Placebo

Standard dose, 3 capsules/time x 3 times/day x 14 days before breakfast, lunch, and dinner combined with standard treatment

Group Type: PLACEBO_COMPARATOR

TD0069 Placebo

Intervention Type: DRUG

TD0069 placebo (800 ± 7.5% mg/capsule) contains excipients

Interventions

TD0069 hard capsule

TD0069 hard capsule (800 ± 7.5% mg/capsule) contains 600 mg fine powder of mixed herbal medicines and 200 mg excipients.

Intervention Type: DRUG

TD0069 Placebo

TD0069 placebo (800 ± 7.5% mg/capsule) contains excipients

Intervention Type: DRUG

Other Intervention Names

Sunkovir; Placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED

UNKNOWN

Sponsor Role: collaborator

Sao Thai Duong Joint Stock Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loc Huynh Nguyen, SL II., MD.

Role: PRINCIPAL_INVESTIGATOR

Traditional Medicine Institute in Ho Chi Minh City

Lan Truong Thi Ngoc, PhD., MD.

Role: PRINCIPAL_INVESTIGATOR

Traditional Medicine Institute in Ho Chi Minh City

Locations

Traditional Medicine Institute in Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh, Vietnam

Hanoi Hospital of Traditional Medicine

Hà Nội, , Vietnam

Countries

Vietnam

Other Identifiers

TD0069-COVID19-III

Identifier Type: -

Identifier Source: org_study_id