Clinical trial NCT05082727: Safety and Efficacy of Softgel KOVIR (TD0068) in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR)
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Sao Thai Duong Joint Stock Company
Sponsor class: INDUSTRY
Collaborators: name: Vietstar Biomedical Research
First posted: 2021-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms: basic dose and placebo
Primary purpose: TREATMENT

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.

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. - 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.

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: 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: Hà Nội
country: Vietnam
facility: National hospital for tropical diseases
Study officials:
affiliation: National hospital for tropical diseases
name: Giang Tran, Dr.,MD.
role: PRINCIPAL_INVESTIGATOR
References: