Safety and Efficacy of Softgel KOVIR (TD0068) in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR)

Phase 2

• Conditions: COVID-19
• Interventions: Dietary Supplement: Placebo oral softgel; Dietary Supplement: KOVIR (TD0068) oral softgel

• Registration Number: NCT05082727
• Lead Sponsor: Sao Thai Duong Joint Stock Company

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 capsule KOVIR is a product based on the traditional medicine 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 capsule KOVIR is a product based on the traditional prescription 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 from July 2021 to December 2022, 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 Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-19
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-02-07
• Primary Completion: 2022-09-15
• Study Completion: 2022-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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. - Quantitative test results for viral load > 4log and or CT value < 30 respiratory fluid samples with the time of sampling within 24 hours from the time of initiation of study treatment.
• 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 influenza or severe acute respiratory infection (as defined by WHO).

• 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.

• Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral softgel	Placebo, 5 capsules/time x 3 times/day x 14 days
KOVIR (TD0068)	KOVIR (TD0068) oral softgel	Standard dose, 5 capsules/time x 3 times/day x 14 days

Primary Outcome Measures

Name	Time	Method
Number of participants without SARS-CoV-2 virus detection after 7 days of treatment	after 7 days of treatment	Assessment using qRT-PCR test
The time from baseline to the peak of viral load of SARS-CoV-2	up to 14 days	Daily assessment using qRT-PCR test
The time from baseline to no SARS-CoV-2 virus detection	up to 14 days	Daily assessment using qRT-PCR test
Number of Participants with Adverse Events as Assessed by CTCAE v5.0	up to 30 days after last dose	Study drug-related adverse events, adverse events leading to study termination, serious
Number of participants with respiratory distress complications requiring treatment	up to 14 days	Appearance of symptoms of respiratory distress complications requiring treatment
Number of participants without SARS-CoV-2 virus detection after 14 days of treatment	after 14 days of treatment	Assessment using qRT-PCR test
Change in the severity of daily symptoms	up to 14 days	Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe
Change in viral load of SARS-CoV-2	up to 14 days	Daily assessment using qRT-PCR test

Trial Locations

Locations (1)

National hospital for tropical diseases; 🇻🇳 Hà Nội, Vietnam