HANOI, Vietnam, Feb. 25, 2022 (GLOBE NEWSWIRE) -- Two studies on COVID-19 patients were conducted in Field Hospital No. 3 by Traditional Medicine Institute of Ho Chi Minh City. The studies were monitored independently by Big Leap. Data were analyzed by independent biostatistician. The studies were performed in accordance with international scientific and ethical principles of the Declaration of Helsinki and the International Conference on Harmonization - Good Clinical Practice guidelines (ICH-GCP). The studies were registered with ClinicalTrials.gov and have been under review in ISI/Scopus journals.
The first study (A66, registered no. CS/YDHDT/21/25) is double-blind randomized, placebo-controlled study with 66 patients (34 patients received KOVIR and 32 received Placebo), performed 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]), performed between August and December 2021.
Standard treatment according to Vietnamese Ministry of Health at the time of the studies included antipyretics, antibiotics, cough suppressants, expectorants, antihistamines, corticosteroids, anticoagulants, nutraceuticals, and no SARS-CoV-2 antiviral drugs.
No progression to severe COVID stages:
Among 734 patients with mild or moderate COVID-19 received KOVIR, none progressed to severe disease stage. In comparison, the rate of progression to severe disease stage (identified by respiratory distress and requiring oxygen support) among patients without KOVIR in study A66 and B1000 were 6.2% and 6.0% respectively.
Significant reduction of COVID symptoms:
KOVIR significantly reduces general COVID symptoms from day 3 onward such as fatigue and vital signs (heart rate, blood pressure, body temperature).
Symptoms that KOVIR significantly reduce includes: cough, short of breath, loss of taste and smell, stuffy nose, aches and pain throughout the body and joints, throat pain, runny nose, headache, fatigue, chest pain, sneezing, sweating, sleepiness.
Significantly reduce COVID treatment duration:
Time needed for COVID clinical symptoms to completely disappear in the KOVIR group was reduced by eight days in comparison to that in the control group (mean of 19 days).
The clinical symptoms included cough, short of breath, loss of taste and smell, stuffy nose, aches and pain throughout the body and joints, throat pain, runny nose, headache, fatigue, chest pain, sneezing, sweating, sleepiness.
Significantly reduce the amount of medication used for COVID treatment:
KOVIR significantly reduces the requirement of corticosteroids, anticoagulants, antipyretics, cough suppressants, expectorants, antihistamines, and drugs for suppressing gastric problems in COVID treatment, compared to the control group.
KOVIR dose of 3 tablets 3 times daily within 14 days is safe for patients with SARS-CoV-2. There were no adverse events and no concerns regarding the safety of the KOVIR in both studies.
The results of the previous pre-clinical studies showed that:
KOVIR did not show any signs of acute toxicity at 37.5 capsules/kg dose.
KOVIR did not cause any sub-chronic toxicity on mice at 1.08 capsules/kg/day dose (9 capsules/day human dose equivalent) and the dose of 3.24 capsules/kg/day (27 capsules/day human dose equivalent) within 30 days.
KOVIR showed the pharmacological activities of improving the immune system at the dose of 1.44 capsules/kg/day (6 capsules/day human dose equivalent) and the dose of 2.16 capsules/kg/day (9 capsules/day human dose equivalent), for oral use continuously within 7 days on the study model of acute immunodeficiency caused by Cyclophosphamide through the indexes of:
+ General immune index: significantly recover the weight of spleen, improve the damage situation of the spleen, thymus on microscopic images, improve recovery of general white blood cells and reduce the amount of deficient white blood cells, compared to model group and control group.
+ Cellular mediated immunity: significantly recover the intradermal reaction caused by Ovalbumin antigen.
+ The human dose of 9 capsules/day improved 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 in the entire reproductive cycle. KOVIR did not cause toxicity in female mice during pregnancy and lactation period. No toxicity was discovered in neonatal mice.
Proposals based on the studies:
KOVIR is recommended for patients with mild or moderate COVID-19 at home and treatment centers to reduce the rate of progression to severe disease, to reduce symptoms rapidly, to reduce the requirement of other medicines, and to shorten the duration of treatment, therefore to reduce pressure on the health system. We recommended to use KOVIR as soon as possible after the diagnosis of COVID-19.
The results of the studies encourage Vietnamese Traditional Medicine to pursue the fight against the pandemic. With a long history of using traditional medicine in treatment of diseases, the Association of Traditional Medicine of Vietnam and its 70.000 members, including physicians in central and regional levels, is carrying out numerous studies to evaluate the results from clinical trials of traditional medicines on COVID-19 patients.
KOVIR contains 100% natural ingredients and is produced by Sunstar JSC - a Vietnam-based science and technology company with 21 years of experience in the field of herbal products. The company currently has more than 150 herbal medicinal products, dietary supplement, and cosmetic products which are sold widely in Vietnam, America, and Europe.
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