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| Name | Class |
|---|---|
| Vietstar Biomedical Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KOVIR (TD0068) | Experimental | Standard dose, 5 capsules/time x 3 times/day x 14 days |
|
| Placebo | Placebo Comparator | Placebo, 5 capsules/time x 3 times/day x 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KOVIR (TD0068) oral softgel | Dietary Supplement | KOVIR (TD0068) is a softgel containing Allium sativum extract 270mg, Colostrum156.4 mg, fine powder mixed herbs 43.6mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in viral load of SARS-CoV-2 | Daily assessment using qRT-PCR test | up to 14 days |
| The time from baseline to the peak of viral load of SARS-CoV-2 | Daily assessment using qRT-PCR test | up to 14 days |
| The time from baseline to no SARS-CoV-2 virus detection | Daily assessment using qRT-PCR test | up to 14 days |
| Number of participants without SARS-CoV-2 virus detection after 7 days of treatment | Assessment using qRT-PCR test | after 7 days of treatment |
| Number of participants without SARS-CoV-2 virus detection after 14 days of treatment | Assessment using qRT-PCR test | after 14 days of treatment |
| Number of participants with respiratory distress complications requiring treatment | Appearance of symptoms of respiratory distress complications requiring treatment | up to 14 days |
| Change in the severity of daily symptoms | Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe | up to 14 days |
| Number of Participants with Adverse Events as Assessed by CTCAE v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thi Hong Van Nguyen | Contact | (+84)916451269 | vannh@thaiduong.com.vn | |
| Tran | Contact | 02435764305 |
| Name | Affiliation | Role |
|---|---|---|
| Giang Tran, Dr.,MD. | National hospital for tropical diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National hospital for tropical diseases | Recruiting | HÃ Ná»™i | Vietnam |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Two arms: basic dose and placebo
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Double Blind (Participant, Investigator)
| Placebo oral softgel | Dietary Supplement | Placebo |
|
Study drug-related adverse events, adverse events leading to study termination, serious
| up to 30 days after last dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |