COVID-19KOVIRNCT05042141
Safety and Efficacy of KOVIR in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR)
A study testing KOVIR oral capsule 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 oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteVietnam
- Study dates
- 28 Jul 2021to 12 Sep 2021
- Phase
- Interventional
- 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, Ct value <30 (equivalent to viral load > 3log)
- 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 upper and lower respiratory tract infections such as dyspnea, SpO2<93%.
- 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.
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- Inability to administer medicine.
- Severe pneumonia as assessed by the investigator.
- 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.
Vietnam1 site
Traditional Medicine Institute in Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: A Study to Evaluate the Safety and Efficacy of KOVIR in the Combination Regimen With Background Treatment in COVID-19 Patients Without Symptoms of Acute Respiratory Distress
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 hard capsule KOVIR is a product based on the traditional medicine named "Nhân sâm bài độc táng" 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 hard capsule KOVIR is a product based on the traditional prescription named "Nhân sâm bài độc táng" 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 about 7 months, 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 oral capsule, Placebo oral capsule
- 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 oral capsuleDietary supplement
KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
Placebo oral capsuleDietary supplement
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| KOVIR | Experimental | Standard dose, 3 capsules/time x 3 times/day x 14 days Receives: Dietary Supplement: KOVIR oral capsule |
| Placebo | Placebo comparator | Placebo, 3 capsules/time x 3 times/day x 14 days Receives: Dietary Supplement: Placebo oral capsule |
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
The cell counts of TD4 and TD8 change from 7 days to 14 days of treatment
Laboratory test of TD4 and TD8
Measured: at day 7 and 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 adverse events (SAE)
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 posted13 Sep 2021
- Study start28 Jul 2021
- Primary completion11 Aug 2021
- Study completion12 Sep 2021
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sao Thai Duong Joint Stock Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Big Leap Research
- Responsible party
- Sponsor
- Investigators
- Loc Huynh, SL II., MD., Principal investigator, Traditional Medicine Institute in Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042141
- Sponsor's protocol ID
- YDHDT-KOVIR
- Acronym
- KOVIR
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 19 Oct 2021
- 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 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of KOVIR in the Combination Regimen With Background Treatment in COVID-19 Patients Without Symptoms of Acute Respiratory Distress
- ClinicalTrials.gov ID
- NCT05042141
- Acronym / sponsor ID
- KOVIR / YDHDT-KOVIR
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sao Thai Duong Joint Stock CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Big Leap Research
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 13 Sep 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 hard capsule KOVIR is a product based on the traditional medicine named "Nhân sâm bài độc táng" 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 hard capsule KOVIR is a product based on the traditional prescription named "Nhân sâm bài độc táng" 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 about 7 months, 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KOVIR | Experimental | Dietary Supplement: KOVIR oral capsuleStandard dose, 3 capsules/time x 3 times/day x 14 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo oral capsulePlacebo, 3 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, Ct value <30 (equivalent to viral load > 3log)
- Voluntary participation in the study by signing an informed consent
- Ability to adhere to treatment according to the investigator's assessment
Key exclusion criteria (9 listed)
- Symptoms of severe upper and lower respiratory tract infections such as dyspnea, SpO2<93%.
- 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.
- Severe pneumonia as assessed by the investigator.
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 oral capsuleKOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg | Dietary supplement | KOVIR |
| Placebo oral capsuleAlso: PlaceboPlacebo | 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
The cell counts of TD4 and TD8 change from 7 days to 14 days of treatment
Time frame: at day 7 and 14 days of treatment
Laboratory test of TD4 and TD8
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 adverse events (SAE)
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 19 Oct 2021.
- 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.
Loc Huynh, SL II., MD. principal investigator
Traditional Medicine Institute in Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOVIR oral capsule 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 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 19 Oct 2021. 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.
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?
Change in viral load of SARS-CoV-2 (time frame: up to 14 days). The study lists 9 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 19 Oct 2021.