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

COVID-19 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05082727
• Other study ID #: KOVIR-COVID19-2B
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: January 2022
• Source: Sao Thai Duong Joint Stock Company
• Contact: Thi Hong Van Nguyen
• Phone: (+84)916451269
• Email: vannh[@]thaiduong.com.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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 oral softgel
Placebo

Locations

Country	Name	City	State
Vietnam	National hospital for tropical diseases	Hà N?i

Sponsors (2)

Lead Sponsor	Collaborator
Sao Thai Duong Joint Stock Company	Vietstar Biomedical Research

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load of SARS-CoV-2	Daily assessment using qRT-PCR test	up to 14 days
Primary	The time from baseline to the peak of viral load of SARS-CoV-2	Daily assessment using qRT-PCR test	up to 14 days
Primary	The time from baseline to no SARS-CoV-2 virus detection	Daily assessment using qRT-PCR test	up to 14 days
Primary	Number of participants without SARS-CoV-2 virus detection after 7 days of treatment	Assessment using qRT-PCR test	after 7 days of treatment
Primary	Number of participants without SARS-CoV-2 virus detection after 14 days of treatment	Assessment using qRT-PCR test	after 14 days of treatment
Primary	Number of participants with respiratory distress complications requiring treatment	Appearance of symptoms of respiratory distress complications requiring treatment	up to 14 days
Primary	Change in the severity of daily symptoms	Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe	up to 14 days
Primary	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