Efficacy Studies of KOVIR Capsule for Mild or Moderate COVID-19 Patients 100% of Mild or Moderate COVID-19 Patients Recover Completely Without Progressing to Later Stages of COVID
HANOI, Vietnam, 25 Feb. 12, 2022 (GLOBE NEWSWIRE) — Two studies of patients with COVID-19 have been conducted at No. 3 Field Hospital by the Institute of Traditional Medicine in Ho Chi Minh City. The studies were tracked independently by Big Leap. The data was analyzed by an independent biostatistician. The studies were performed in accordance with the international scientific and ethical principles of the Declaration of Helsinki and the International Conference on Harmonization – Good Clinical Practice Guidelines (ICH-GCP). Studies were registered with ClinicalTrials.gov and reviewed in ISI/Scopus journals.
The first study (A66, registered as CS/YDHDT/21/25) is a randomized, double-blind, placebo-controlled study with 66 patients (34 patients received KOVIR and 32 received placebo), carried out between July and September 2021.
The second study (B1000, registered no. CS/YDHDT/21/26) is a non-randomized trial with 1000 COVID-19 patients without respiratory distress (700 patients with KOVIR and 300 without KOVIR [control group]), carried out between August and December 2021.
Standard treatment according to the Vietnamese Ministry of Health at the time of the studies included antipyretics, antibiotics, antitussives, expectorants, antihistamines, corticosteroids, anticoagulants, nutraceuticals and no SARS-CoV-2 antivirals.
No progression to severe COVID stages:
Of the 734 patients with mild or moderate COVID-19 who received KOVIR, none progressed to severe disease. In comparison, the rate of progression to severe disease (identified by respiratory distress and requiring oxygen support) in patients without KOVIR in studies A66 and B1000 was 6.2% and 6.0%, respectively. .
Significant reduction in COVID symptoms:
KOVIR significantly reduces general COVID symptoms from day 3, such as fatigue and vital signs (heart rate, blood pressure, body temperature).
Symptoms that KOVIR dramatically reduces include: cough, shortness of breath, loss of taste and smell, stuffy nose, pain throughout body and joints, sore throat, runny nose, headache, fatigue, chest pain, sneezing , sweating, drowsiness.
Significantly reduce the duration of COVID treatment:
The time it took for clinical COVID symptoms to completely resolve in the KOVIR group was reduced by eight days compared to the control group (mean of 19 days).
Clinical symptoms included cough, shortness of breath, loss of taste and smell, stuffy nose, aches and pains throughout body and joints, sore throat, runny nose, headache, fatigue, chest pain, sneezing, sweating , drowsiness.
Significantly reduce the amount of drugs used for COVID treatment:
KOVIR significantly reduces the need for corticosteroids, anticoagulants, antipyretics, antitussives, expectorants, antihistamines and drugs to suppress gastric problems in the COVID treatment, compared to the control group.
The KOVIR dose of 3 tablets 3 times a day for 14 days is safe for patients with SARS-CoV-2. There were no adverse events and no safety concerns with KOVIR in either study.
The results of previous preclinical studies have shown that:
KOVIR showed no signs of acute toxicity at a dose of 37.5 capsules/kg.
KOVIR did not induce subchronic toxicity in mice at a dose of 1.08 capsules/kg/day (human dose equivalent of 9 capsules/day) and at a dose of 3.24 capsules/kg/day (equivalent of human dose of 27 capsules/day) within 30 days.
KOVIR showed immune system enhancing pharmacological activities at a dose of 1.44 capsules/kg/day (human dose equivalent of 6 capsules/day) and at a dose of 2.16 capsules/kg/day (equivalent to human dose of 9 capsules/day), for continuous oral administration for 7 days on the study model of acute immunodeficiency caused by Cyclophosphamide through the indices of:
+ General immune index: significantly recovers the weight of the spleen, improves the situation of damage to the spleen, thymus on the microscopic images, improves the recovery of the general white blood cells and reduces the amount of deficient white blood cells, compared to the model group and control group.
+ Cell-mediated immunity: significantly recovers the intradermal reaction caused by the Ovalbumin antigen.
+ Human dose of 9 capsules/day improves recovery of IL-2 concentration.
The results of reproductive toxicity studies of KOVIR at doses of 1.44 capsules/kg/day (6 capsules/day human dose equivalent) and 2.16 capsules/kg/day (9 capsules/day human dose equivalent) showed that KOVIR did not produce reproductive toxicity. in male and female mice throughout the reproductive cycle. KOVIR did not cause toxicity in female mice during gestation and lactation. No toxicity was found in newborn mice.
Proposals based on the studies:
KOVIR is recommended for patients with mild to moderate COVID-19 at home and in treatment centers to reduce the rate of progression to severe disease, quickly reduce symptoms, reduce the need for other medications, and shorten the duration of treatment , therefore to reduce the pressure on the health system. We recommended using KOVIR as soon as possible after diagnosis of COVID-19.
The results of the studies encourage Vietnamese traditional medicine to continue the fight against the pandemic. With a long history of using traditional medicine in the treatment of diseases, the Vietnam Traditional Medicine Association and its 70,000 members, including doctors at central and regional levels, conduct numerous studies to assess the results of clinical trials of traditional medicines on COVID -19 patients.
KOVIR contains 100% natural ingredients and is produced by Sunstar JSC – a science and technology company based in Vietnam with 21 years of experience in the field of herbal products. The company currently has more than 150 herbal medicinal products, dietary supplements and cosmetic products which are widely sold in Vietnam, America and Europe.
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