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| Name | Class |
|---|---|
| Big Leap Research | OTHER |
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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 hard capsule KOVIR is a product based on the traditional medicine named "Nhân sâm bà i độc táng" 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 hard capsule KOVIR is a product based on the traditional prescription named "Nhân sâm bà i 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KOVIR | Experimental | Standard dose, 3 capsules/time x 3 times/day x 14 days |
|
| Placebo | Placebo Comparator | Placebo, 3 capsules/time x 3 times/day x 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KOVIR oral capsule | Dietary Supplement | KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg |
|
| 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 |
| The cell counts of TD4 and TD8 change from 7 days to 14 days of treatment | Laboratory test of TD4 and TD8 | 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 | up to 14 days |
| Change in the severity of daily symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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.
Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators.
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| Name | Affiliation | Role |
|---|---|---|
| Loc Huynh, SL II., MD. | Traditional Medicine Institute in Ho Chi Minh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Traditional Medicine Institute in Ho Chi Minh City | Ho Chi Minh City | 700000 | Vietnam |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 25, 2022 | |
| Reset | Sep 5, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 25, 2022 | Sep 5, 2023 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo oral capsule | Dietary Supplement | Placebo |
|
|
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 | Study drug-related adverse events, adverse events leading to study termination, serious adverse events (SAE) | 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 |