Efficacy of KOVIR Capsule in the Combination Regimen With Background Treatment in COVID-19 Patients

NCT05044650 | Unknown

• 1 other identifier: YDHDT-KOVIR-B
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely 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 named "Ren shen bai du san" 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 (4)

• Mean duration of clinical symptoms

  Mean time from baseline to no clinical symptom of COVID-19

  up to 14 days

• Number of participants with respiratory distress complications requiring treatment

  Occurrence 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

  Frequency and severity of 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 combined with background treatment

Dietary Supplement: KOVIR capsule combined with background treatment

NON-KOVIR

NO INTERVENTION

Only background treatment

Interventions

KOVIR capsule combined with background treatment DIETARY_SUPPLEMENT

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

KOVIR

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, aged from 18-65, 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

Central Study Contacts

Thi Hong Van Nguyen, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned randomly 7:3 to either KOVIR group or Non-KOVIR group respectively.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 16, 2021
• Study Start: June 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 4, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)