Safety and Efficacy of KOVIR in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR)

Sao Thai Duong

Status

Completed

Conditions

COVID-19

Treatments

Dietary Supplement: KOVIR oral capsule

Dietary Supplement: Placebo oral capsule

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05042141

YDHDT-KOVIR

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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:
- 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.
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.