Clinical trial NCT05042141: Safety and Efficacy of KOVIR in the Combination Regimen With Background Treatment in COVID-19 Patients (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Sao Thai Duong Joint Stock Company
Sponsor class: INDUSTRY
Collaborators: name: Big Leap Research
First posted: 2021-09-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in viral load of SARS-CoV-2
timeFrame: up to 14 days
measure: The time from baseline to the peak of viral load of SARS-CoV-2
timeFrame: up to 14 days
measure: The time from baseline to no SARS-CoV-2 virus detection
timeFrame: up to 14 days
measure: Number of participants without SARS-CoV-2 virus detection after 7 days of treatment
timeFrame: after 7 days of treatment
measure: Number of participants without SARS-CoV-2 virus detection after 14 days of treatment
timeFrame: after 14 days of treatment
measure: The cell counts of TD4 and TD8 change from 7 days to 14 days of treatment
timeFrame: at day 7 and 14 days of treatment
measure: Number of participants with respiratory distress complications requiring treatment
timeFrame: up to 14 days
measure: Change in the severity of daily symptoms
timeFrame: up to 14 days
measure: Number of Participants with Adverse Events as Assessed by CTCAE v5.0
timeFrame: up to 30 days after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Traditional Medicine Institute in Ho Chi Minh City
Study officials:
affiliation: Traditional Medicine Institute in Ho Chi Minh City
name: Loc Huynh, SL II., MD.
role: PRINCIPAL_INVESTIGATOR
References: