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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Dietary supplement: KOVIR oral capsule; Dietary supplement: Placebo oral capsule

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • Traditional Medicine Institute in Ho Chi Minh City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KOVIR; Standard dose, 3 capsules/time x 3 times/day x 14 days	Dietary supplement: KOVIR oral capsule; KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
Placebo Comparator: Placebo; Placebo, 3 capsules/time x 3 times/day x 14 days	Dietary supplement: Placebo oral capsule; Placebo; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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	Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe	up to 14 days
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 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

Collaborators and Investigators

• Sponsor: Sao Thai Duong Joint Stock Company
• Collaborators: Big Leap Clinical Research Joint Stock Company
• Investigators: Principal Investigator: Loc Huynh, SL II., MD., Traditional Medicine Institute in Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): August 11, 2021
• Study Completion (Actual): September 12, 2021

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: YDHDT-KOVIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No