COVID-19Phase 3NCT05249777
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
A Phase 3 study testing TD0069 hard capsule in people with COVID-19, run by Sao Thai Duong Joint Stock Company at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- TD0069 hard capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 573 participants
- Where
- 2 sitesVietnam
- Study dates
- 6 Jan 2022to 10 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Hanoi Hospital of Traditional Medicine
Hà Nội
Traditional Medicine Institute in Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh
About this study
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.
Read the 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
- Being tested
- TD0069 hard capsule, TD0069 Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD0069 hard capsuleDrug
Also called Sunkovir
TD0069 hard capsule (800 ± 7.5% mg/capsule) contains 600 mg fine powder of mixed herbal medicines and 200 mg excipients.
TD0069 PlaceboDrug
Also called Placebo
TD0069 placebo (800 ± 7.5% mg/capsule) contains excipients
| Study group | Role | What they receive |
|---|---|---|
| TD0069 | Experimental | Standard dose, 3 capsules/time x 3 times/day x 14 days before breakfast, lunch, and dinner combined with standard treatment. Receives: 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 Receives: Drug: TD0069 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 28 days
Secondary outcomes (5)
The rate of Covid-19 diseases according to traditional medicine
Covid-19 diseases according to traditional medicine
Measured: up to 14 days
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
Measured: up to 14 days
The length of hospital stay
Date of discharge minus date of admission
Measured: up to 14 days
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.
Measured: Day 5, day 7, day 9, and day 14
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
Measured: Day 0, day 7, day 14, and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start6 Jan 2022
- Primary completion5 Aug 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sao Thai Duong Joint Stock Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED
- Responsible party
- Sponsor
- Investigators
- Loc Huynh Nguyen, SL II., MD., Principal investigator, Traditional Medicine Institute in Ho Chi Minh CityLan Truong Thi Ngoc, PhD., MD., Principal investigator, Traditional Medicine Institute in Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249777
- Sponsor's protocol ID
- TD0069-COVID19-III
- Status last verified
- Sep 2022
- First submitted
- 21 Feb 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05249777
- Acronym / sponsor ID
- TD0069-COVID19-III
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Sao Thai Duong Joint Stock CompanyIndustry (pharma, biotech, devices)
- Collaborators
- CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TD0069 | Experimental | Drug: TD0069 hard capsuleStandard dose, 3 capsules/time x 3 times/day x 14 days before breakfast, lunch, and dinner combined with standard treatment. |
| Placebo | Placebo comparator | Drug: TD0069 PlaceboStandard dose, 3 capsules/time x 3 times/day x 14 days before breakfast, lunch, and dinner combined with standard treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD0069 hard capsuleAlso: SunkovirTD0069 hard capsule (800 ± 7.5% mg/capsule) contains 600 mg fine powder of mixed herbal medicines and 200 mg excipients. | Drug | TD0069 |
| TD0069 PlaceboAlso: PlaceboTD0069 placebo (800 ± 7.5% mg/capsule) contains excipients | Drug | Placebo |
Primary outcome
The rate of patients with serious diseases/conditions related to Covid-19
Time frame: up to 28 days
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
Time frame: up to 14 days
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
Time frame: up to 14 days
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
Time frame: up to 28 days
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.
5 secondary outcomes
The rate of Covid-19 diseases according to traditional medicine
Time frame: up to 14 days
Time to symptom resolution of Covid-19 diseases according to traditional medicine
Time frame: up to 14 days
The length of hospital stay
Time frame: up to 14 days
The rate of Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
Time frame: Day 5, day 7, day 9, and day 14
The quality of life at day 0, day 7, day 14, and day 28
Time frame: Day 0, day 7, day 14, and day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loc Huynh Nguyen, SL II., MD. principal investigator
Traditional Medicine Institute in Ho Chi Minh City
Lan Truong Thi Ngoc, PhD., MD. principal investigator
Traditional Medicine Institute in Ho Chi Minh City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TD0069 hard capsule in people with COVID-19, run by Sao Thai Duong Joint Stock Company at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients with serious diseases/conditions related to Covid-19 (time frame: up to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.