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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
KOVIR (TD0068) is a softgel containing Allium sativum extract 270mg, Colostrum156.4 mg, fine powder mixed herbs 43.6mg
Placebo
National hospital for tropical diseases
Hà Nội, Vietnam
RECRUITINGChange in viral load of SARS-CoV-2
Daily assessment using qRT-PCR test
Time frame: up to 14 days
The time from baseline to the peak of viral load of SARS-CoV-2
Daily assessment using qRT-PCR test
Time frame: up to 14 days
The time from baseline to no SARS-CoV-2 virus detection
Daily assessment using qRT-PCR test
Time frame: up to 14 days
Number of participants without SARS-CoV-2 virus detection after 7 days of treatment
Assessment using qRT-PCR test
Time frame: after 7 days of treatment
Number of participants without SARS-CoV-2 virus detection after 14 days of treatment
Assessment using qRT-PCR test
Time frame: after 14 days of treatment
Number of participants with respiratory distress complications requiring treatment
Appearance of symptoms of respiratory distress complications requiring treatment
Time frame: up to 14 days
Change in the severity of daily symptoms
Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe
Time frame: 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
Time frame: up to 30 days after last dose
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