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

Randomized, Double-blind, Placebo-controlled, Phase IIb Study, Safety Evaluation and Exploration of the Effect on Virologic Dynamics of Softgel KOVIR (TD.0068) in Combination With Background Therapy in Patients With Patients With COVID-19 Have Not Shown Signs of Acute Respiratory Failure.

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Dietary supplement: KOVIR (TD0068) oral softgel; Dietary supplement: Placebo oral softgel

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Thi Hong Van Nguyen; Phone Number: (+84)916451269; Email: vannh@thaiduong.com.vn
• Study Contact Backup: Name: Tran; Phone Number: 02435764305

Study Locations

• Vietnam
  • Hà Nội, Vietnam
    • Recruiting
    • National Hospital for Tropical Diseases
    • Contact: Giang Tran, Dr., MD.; Phone Number: (+84-24) 35764305

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. - 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KOVIR (TD0068); Standard dose, 5 capsules/time x 3 times/day x 14 days	Dietary supplement: KOVIR (TD0068) oral softgel; KOVIR (TD0068) is a softgel containing Allium sativum extract 270mg, Colostrum156.4 mg, fine powder mixed herbs 43.6mg
Placebo Comparator: Placebo; Placebo, 5 capsules/time x 3 times/day x 14 days	Dietary supplement: Placebo oral softgel; 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
Number of Participants with Adverse Events as Assessed by CTCAE v5.0	Study drug-related adverse events, adverse events leading to study termination, serious	up to 30 days after last dose

Collaborators and Investigators

• Sponsor: Sao Thai Duong Joint Stock Company
• Collaborators: Vietstar Biomedical Research
• Investigators: Principal Investigator: Giang Tran, Dr.,MD., National Hospital for Tropical Diseases

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): September 15, 2022
• Study Completion (Anticipated): November 15, 2022

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

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: KOVIR-COVID19-2B

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