Efficacy of KOVIR Capsule in the Combination Regimen With Background Treatment in COVID-19 Patients
NCT ID: NCT05044650
Last Updated: 2022-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2022-06-30
2022-06-30
Brief Summary
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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.
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Detailed Description
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The capsule KOVIR is a product based on the traditional prescription 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.
The study compares between standard dose regimen of KOVIR combined with background treatment in COVID-19 patients and only background treatment in COVID-19 patients. The study will enroll 700 participants to KOVIR group and 300 participant to Non-KOVIR group.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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KOVIR
Standard dose, 3 capsules/time x 3 times/day x 14 days combined with background treatment
KOVIR capsule combined with background treatment
KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
NON-KOVIR
Only background treatment
No interventions assigned to this group
Interventions
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KOVIR capsule combined with background treatment
KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Big Leap Research
OTHER
Sao Thai Duong Joint Stock Company
INDUSTRY
Responsible Party
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Principal Investigators
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Loc Huynh, SL II., MD.
Role: PRINCIPAL_INVESTIGATOR
Traditional Medicine Institute in Ho Chi Minh City
Locations
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Traditional Medicine Institute in Ho Chi Minh City
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YDHDT-KOVIR-B
Identifier Type: -
Identifier Source: org_study_id
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