Clinical trial NCT05249777: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Sao Thai Duong Joint Stock Company
Sponsor class: INDUSTRY
Collaborators: name: CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED
First posted: 2022-02-22
Enrollment: 573
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The rate of patients with serious diseases/conditions related to Covid-19
timeFrame: up to 28 days
measure: Daily symptoms improvement
timeFrame: up to 14 days
measure: Time to clinical symptom resolution
timeFrame: up to 14 days
measure: The rate and severity grade of adverse events related to the investigational product
timeFrame: up to 28 days
Secondary outcomes:
measure: The rate of Covid-19 diseases according to traditional medicine
timeFrame: up to 14 days
measure: Time to symptom resolution of Covid-19 diseases according to traditional medicine
timeFrame: up to 14 days
measure: The length of hospital stay
timeFrame: up to 14 days
measure: The rate of Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
timeFrame: Day 5, day 7, day 9, and day 14
measure: The quality of life at day 0, day 7, day 14, and day 28
timeFrame: Day 0, day 7, day 14, and day 28
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Traditional Medicine Institute in Ho Chi Minh City
state: Ho Chi Minh
city: Ha Noi
country: Vietnam
facility: Hanoi Hospital of Traditional Medicine
Study officials:
affiliation: Traditional Medicine Institute in Ho Chi Minh City
name: Loc Huynh Nguyen, SL II., MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Traditional Medicine Institute in Ho Chi Minh City
name: Lan Truong Thi Ngoc, PhD., MD.
role: PRINCIPAL_INVESTIGATOR
References: