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

NCT05042141 | Completed

• 1 other identifier: YDHDT-KOVIR
• Study Type: interventional
• Target: 66
• 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 hard capsule KOVIR is a product based on the traditional medicine named "Nhân sâm bài độc táng" 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 (9)

• 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

• The cell counts of TD4 and TD8 change from 7 days to 14 days of treatment

  Laboratory test of TD4 and TD8

  at day 7 and 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 adverse events (SAE)

  up to 30 days after last dose

Study Arms (2)

KOVIR

EXPERIMENTAL

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

Dietary Supplement: KOVIR oral capsule

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo oral capsule

Interventions

KOVIR oral capsule DIETARY_SUPPLEMENT

KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg

KOVIR

Placebo oral capsule DIETARY_SUPPLEMENT

Placebo

Also known as: 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, Ct value \<30 (equivalent to viral load \> 3log)
• 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 upper and lower respiratory tract infections such as dyspnea, SpO2\<93%.
• 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.
• Severe pneumonia as assessed by the investigator.
• 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
• Big Leap Research: collaborator

Study Sites (1)

Traditional Medicine Institute in Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location

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

• Loc Huynh, SL II., MD.

  Traditional Medicine Institute in Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 13, 2021
• Study Start: July 28, 2021
• Primary Completion: August 11, 2021
• Study Completion: September 12, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)