Safety and Efficacy of KOVIR in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR)
NCT ID: NCT05042141
Last Updated: 2021-10-19
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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COMPLETED
NA
66 participants
INTERVENTIONAL
2021-07-28
2021-09-12
Brief Summary
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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.
Detailed Description
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The hard capsule KOVIR is a product based on the traditional prescription 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.
The study timeline is expected about 7 months, 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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KOVIR
Standard dose, 3 capsules/time x 3 times/day x 14 days
KOVIR oral capsule
KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
Placebo
Placebo, 3 capsules/time x 3 times/day x 14 days
Placebo oral capsule
Placebo
Interventions
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KOVIR oral capsule
KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
Placebo oral capsule
Placebo
Other Intervention Names
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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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Other Identifiers
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YDHDT-KOVIR
Identifier Type: -
Identifier Source: org_study_id