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Completed

NCT Number: NCT05042141

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Traditional Medicine Institute in Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KOVIR oral capsule

Dietary Supplement

KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg

Placebo oral capsule

Dietary Supplement

Placebo

Other names: Placebo

Primary outcomes

  1. Change in viral load of SARS-CoV-2

    Time frame: up to 14 days

    Daily assessment using qRT-PCR test

  2. The time from baseline to the peak of viral load of SARS-CoV-2

    Time frame: up to 14 days

    Daily assessment using qRT-PCR test

  3. The time from baseline to no SARS-CoV-2 virus detection

    Time frame: up to 14 days

    Daily assessment using qRT-PCR test

  4. Number of participants without SARS-CoV-2 virus detection after 7 days of treatment

    Time frame: after 7 days of treatment

    Assessment using qRT-PCR test

  5. Number of participants without SARS-CoV-2 virus detection after 14 days of treatment

    Time frame: after 14 days of treatment

    Assessment using qRT-PCR test

  6. The cell counts of TD4 and TD8 change from 7 days to 14 days of treatment

    Time frame: at day 7 and 14 days of treatment

    Laboratory test of TD4 and TD8

  7. Number of participants with respiratory distress complications requiring treatment

    Time frame: up to 14 days

    Appearance of symptoms of respiratory distress complications requiring treatment

  8. Change in the severity of daily symptoms

    Time frame: up to 14 days

    Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe

  9. Number of Participants with Adverse Events as Assessed by CTCAE v5.0

    Time frame: up to 30 days after last dose

    Study drug-related adverse events, adverse events leading to study termination, serious adverse events (SAE)

Sponsors and collaborators

Lead sponsor

Sao Thai Duong Joint Stock Company

Industry

Collaborators

  • Big Leap Research

Registry information

Official study 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

Acronym: KOVIR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2021
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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