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

COVID-19 Clinical Trial

— KOVIR  

Official title:

A Study to Evaluate the Safety and Efficacy of KOVIR in the Combination Regimen With Background Treatment in COVID-19 Patients Without Symptoms of Acute Respiratory Distress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05042141
• Other study ID #: YDHDT-KOVIR
• Status: Completed
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: September 12, 2021

Study information

• Verified date: September 2021
• Source: Sunstar Joint Stock Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 12, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Dietary Supplement:
• KOVIR oral capsule
KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
• Placebo oral capsule
Placebo

Locations

Country	Name	City	State
Vietnam	Traditional Medicine Institute in Ho Chi Minh City	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
Sunstar Joint Stock Company	Big Leap Clinical Research Joint Stock Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load of SARS-CoV-2	Daily assessment using qRT-PCR test	up to 14 days
Primary	The time from baseline to the peak of viral load of SARS-CoV-2	Daily assessment using qRT-PCR test	up to 14 days
Primary	The time from baseline to no SARS-CoV-2 virus detection	Daily assessment using qRT-PCR test	up to 14 days
Primary	Number of participants without SARS-CoV-2 virus detection after 7 days of treatment	Assessment using qRT-PCR test	after 7 days of treatment
Primary	Number of participants without SARS-CoV-2 virus detection after 14 days of treatment	Assessment using qRT-PCR test	after 14 days of treatment
Primary	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
Primary	Number of participants with respiratory distress complications requiring treatment	Appearance of symptoms of respiratory distress complications requiring treatment	up to 14 days
Primary	Change in the severity of daily symptoms	Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe	up to 14 days
Primary	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