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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, 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 KOVIR 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.
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 KOVIR 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 KOVIR combined with background treatment in COVID-19 patients and only background treatment in COVID-19 patients. The study will enroll 700 participants to KOVIR group and 300 participant to Non-KOVIR group.
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 combined with background treatment |
|
| NON-KOVIR | No Intervention | Only background treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KOVIR capsule combined with background treatment | Dietary Supplement | KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean duration of clinical symptoms | Mean time from baseline to no clinical symptom of COVID-19 | up to 14 days |
| Number of participants with respiratory distress complications requiring treatment | Occurrence 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 | Frequency and severity of Study drug-related adverse events, adverse events leading to study termination, serious adverse events (SAE) | up to 30 days after last dose |
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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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Thi Hong Van Nguyen, MSc | Contact | (+84)916451269 | vannh@thaiduong.com.vn |
| 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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Participants will be assigned randomly 7:3 to either KOVIR group or Non-KOVIR group respectively.
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |