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

NCT05082727 | Unknown Phase 2

• 1 other identifier: KOVIR-COVID19-2B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

KOVIR (TD0068)

EXPERIMENTAL

Standard dose, 5 capsules/time x 3 times/day x 14 days

Dietary Supplement: KOVIR (TD0068) oral softgel

Placebo

PLACEBO COMPARATOR

Placebo, 5 capsules/time x 3 times/day x 14 days

Dietary Supplement: Placebo oral softgel

Interventions

KOVIR (TD0068) oral softgel DIETARY_SUPPLEMENT

KOVIR (TD0068) is a softgel containing Allium sativum extract 270mg, Colostrum156.4 mg, fine powder mixed herbs 43.6mg

KOVIR (TD0068)

Placebo oral softgel DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sao Thai Duong Joint Stock Company: lead
• Vietstar Biomedical Research: collaborator

Study Sites (1)

National hospital for tropical diseases

Hà Nội, Vietnam

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Giang Tran, Dr.,MD.

  National hospital for tropical diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thi Hong Van Nguyen

CONTACT

(+84)916451269; vannh@thaiduong.com.vn

Tran

CONTACT

02435764305

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two arms: basic dose and placebo

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 19, 2021
• Study Start: July 1, 2021
• Primary Completion: September 15, 2022
• Study Completion: November 15, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)