COVID-19Phase 2NCT05082727
Safety and Efficacy of Softgel KOVIR (TD0068) in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR)
A Phase 2 study testing KOVIR (TD0068) oral softgel in people with COVID-19, run by Sao Thai Duong Joint Stock Company at 1 site in Vietnam.
Trial summary
The acute pneumonia pandemic caused by a new strain of corona virus 2019 named 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?
- KOVIR (TD0068) oral softgel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jul 2021to 15 Nov 2022
- Phase
- Phase 2
- 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
- Male or female, age from 18 to 65 years old, Vietnamese nationality
- Participants diagnosed with Positive result of SARS-CoV-2 using real time RT-PCR test. - Quantitative test results for viral load > 4log and or CT value < 30 respiratory fluid samples with the time of sampling within 24 hours from the time of initiation of study treatment.
- Voluntary participation in the study by signing an informed consent
- Ability to adhere to treatment according to the investigator's assessment
Who cannot join
- Symptoms of severe influenza or severe acute respiratory infection (as defined by WHO).
- Acute reduction of ventilation function of respiratory apparatus and/or respiration function of the lung in any of the following three groups:
- Respiratory distress due to hypoxemia with PaO2 less than 60mmHg when breathing room air.
- Respiratory distress due to hypercapnia with PaCO2 above 50mmHg
- Mixed respiratory distress accompanied by both a decrease in PaO2 and an increase in PaCO2
- Allergy/intolerance to any component of the study drug.
- Inability to administer medicine.
- Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators.
Trial locations and contacts
1 site in 1 country.
Tran contact
Vietnam1 site, 1 recruiting
- Recruiting
National hospital for tropical diseases
Hà Nội
Giang Tran, Dr., MD., (+84-24) 35764305
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Phase IIb Study, Safety Evaluation and Exploration of the Effect on Virologic Dynamics of Softgel KOVIR (TD.0068) in Combination With Background Therapy in Patients With Patients With COVID-19 Have Not Shown Signs of Acute Respiratory Failure.
The acute pneumonia pandemic caused by a new strain of corona virus 2019 named 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 KOVIR is a product based on the traditional medicine 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 named 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 KOVIR is a product based on the traditional prescription which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.
The study timeline is expected from July 2021 to December 2022, including enrolment period, 14 days of treatment, data entry and analysis.
The study compares between standard dose regimen of KOVIR combined with background treatment in COVID-19 patients and placebo combined with background treatment in COVID-19 patients.
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.
Screening procedures occur at Day 1. Periodic assessments are conducted daily from Day 2-14. Finally, End of study visit is conducted.
- Conditions
- COVID-19
- Being tested
- KOVIR (TD0068) oral softgel, Placebo oral softgel
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOVIR (TD0068) oral softgelDietary supplement
KOVIR (TD0068) is a softgel containing Allium sativum extract 270mg, Colostrum156.4 mg, fine powder mixed herbs 43.6mg
Placebo oral softgelDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| KOVIR (TD0068) | Experimental | Standard dose, 5 capsules/time x 3 times/day x 14 days Receives: Dietary Supplement: KOVIR (TD0068) oral softgel |
| Placebo | Placebo comparator | Placebo, 5 capsules/time x 3 times/day x 14 days Receives: Dietary Supplement: Placebo oral softgel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load of SARS-CoV-2
Daily assessment using qRT-PCR test
Measured: up to 14 days
The time from baseline to the peak of viral load of SARS-CoV-2
Daily assessment using qRT-PCR test
Measured: up to 14 days
The time from baseline to no SARS-CoV-2 virus detection
Daily assessment using qRT-PCR test
Measured: up to 14 days
Number of participants without SARS-CoV-2 virus detection after 7 days of treatment
Assessment using qRT-PCR test
Measured: after 7 days of treatment
Number of participants without SARS-CoV-2 virus detection after 14 days of treatment
Assessment using qRT-PCR test
Measured: after 14 days of treatment
Number of participants with respiratory distress complications requiring treatment
Appearance of symptoms of respiratory distress complications requiring treatment
Measured: up to 14 days
Change in the severity of daily symptoms
Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe
Measured: up to 14 days
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Study drug-related adverse events, adverse events leading to study termination, serious
Measured: up to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Jul 2021
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms: basic dose and placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sao Thai Duong Joint Stock Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vietstar Biomedical Research
- Responsible party
- Sponsor
- Investigators
- Giang Tran, Dr.,MD., Principal investigator, National hospital for tropical diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082727
- Sponsor's protocol ID
- KOVIR-COVID19-2B
- Status last verified
- Jan 2022
- First submitted
- 15 Oct 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Phase IIb Study, Safety Evaluation and Exploration of the Effect on Virologic Dynamics of Softgel KOVIR (TD.0068) in Combination With Background Therapy in Patients With Patients With COVID-19 Have Not Shown Signs of Acute Respiratory Failure.
- ClinicalTrials.gov ID
- NCT05082727
- Acronym / sponsor ID
- KOVIR-COVID19-2B
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sao Thai Duong Joint Stock CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Vietstar Biomedical Research
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 19 Oct 2021 (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 named 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 KOVIR is a product based on the traditional medicine 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 named 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 KOVIR is a product based on the traditional prescription which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.
The study timeline is expected from July 2021 to December 2022, including enrolment period, 14 days of treatment, data entry and analysis.
The study compares between standard dose regimen of KOVIR combined with background treatment in COVID-19 patients and placebo combined with background treatment in COVID-19 patients.
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.
Screening procedures occur at Day 1. Periodic assessments are conducted daily from Day 2-14. Finally, End of study visit is conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two arms: basic dose and placebo
| Arm | Type | Receives |
|---|---|---|
| KOVIR (TD0068) | Experimental | Dietary Supplement: KOVIR (TD0068) oral softgelStandard dose, 5 capsules/time x 3 times/day x 14 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo oral softgelPlacebo, 5 capsules/time x 3 times/day x 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age from 18 to 65 years old, Vietnamese nationality
- Participants diagnosed with Positive result of SARS-CoV-2 using real time RT-PCR test. - Quantitative test results for viral load > 4log and or CT value < 30 respiratory fluid samples with the time of sampling within 24 hours from the time of initiation of study treatment.
- Voluntary participation in the study by signing an informed consent
- Ability to adhere to treatment according to the investigator's assessment
Key exclusion criteria (8 listed)
- Symptoms of severe influenza or severe acute respiratory infection (as defined by WHO).
- Acute reduction of ventilation function of respiratory apparatus and/or respiration function of the lung in any of the following three groups:
- Allergy/intolerance to any component of the study drug.
- Inability to administer medicine.
- Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators.
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 |
|---|---|---|
| KOVIR (TD0068) oral softgelKOVIR (TD0068) is a softgel containing Allium sativum extract 270mg, Colostrum156.4 mg, fine powder mixed herbs 43.6mg | Dietary supplement | KOVIR (TD0068) |
| Placebo oral softgelPlacebo | Dietary supplement | Placebo |
Primary outcome
Change in viral load of SARS-CoV-2
Time frame: up to 14 days
Daily assessment using qRT-PCR test
The time from baseline to the peak of viral load of SARS-CoV-2
Time frame: up to 14 days
Daily assessment using qRT-PCR test
The time from baseline to no SARS-CoV-2 virus detection
Time frame: up to 14 days
Daily assessment using qRT-PCR test
Number of participants without SARS-CoV-2 virus detection after 7 days of treatment
Time frame: after 7 days of treatment
Assessment using qRT-PCR test
Number of participants without SARS-CoV-2 virus detection after 14 days of treatment
Time frame: after 14 days of treatment
Assessment using qRT-PCR test
Number of participants with respiratory distress complications requiring treatment
Time frame: up to 14 days
Appearance of symptoms of respiratory distress complications requiring treatment
Change in the severity of daily symptoms
Time frame: up to 14 days
Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Time frame: up to 30 days after last dose
Study drug-related adverse events, adverse events leading to study termination, serious
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Tran contact
Giang Tran, Dr.,MD. principal investigator
National hospital for tropical diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KOVIR (TD0068) oral softgel in people with COVID-19, run by Sao Thai Duong Joint Stock Company at 1 site 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thi Hong Van Nguyen ((+84)916451269, vannh@thaiduong.com.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in viral load of SARS-CoV-2 (time frame: up to 14 days). The study lists 8 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 7 Feb 2022.