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

NCT05249777 | Completed Phase 3

• 1 other identifier: TD0069-COVID19-III
• Study Type: interventional
• Target: 573
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• 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

  up to 28 days

• 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.

  up to 14 days

• Time to clinical symptom resolution

  Mean time from randomization to symptom resolution in terms of general, cardiovascular, respiratory, digestive, musculoskeletal, neurological, and dermatological symptoms

  up to 14 days

• 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.

  up to 28 days

Secondary Outcomes (5)

• The rate of Covid-19 diseases according to traditional medicine

  up to 14 days

• Time to symptom resolution of Covid-19 diseases according to traditional medicine

  up to 14 days

• The length of hospital stay

  up to 14 days

• The rate of Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs

  Day 5, day 7, day 9, and day 14

• The quality of life at day 0, day 7, day 14, and day 28

  Day 0, day 7, day 14, and day 28

Study Arms (2)

TD0069

EXPERIMENTAL

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

Drug: TD0069 hard capsule

Placebo

PLACEBO COMPARATOR

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

Drug: TD0069 Placebo

Interventions

TD0069 hard capsule DRUG

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

Also known as: Sunkovir

TD0069

TD0069 Placebo DRUG

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sao Thai Duong Joint Stock Company: lead
• CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED: collaborator

Study Sites (2)

Traditional Medicine Institute in Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh, Vietnam

Location

Hanoi Hospital of Traditional Medicine

Hà Nội, Vietnam

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Loc Huynh Nguyen, SL II., MD.

  Traditional Medicine Institute in Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

• Lan Truong Thi Ngoc, PhD., MD.

  Traditional Medicine Institute in Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: February 22, 2022
• Study Start: January 6, 2022
• Primary Completion: August 5, 2022
• Study Completion: September 10, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

VN (2)