Synthesized as of medicinal herbs whose names the scientist did not reveal, the medication remains under evaluation for its safety, stability and capability to inhibit the spread of the deadly virus, as well as A/H5N1 influenza.
“Vietnam has many drugs extracted from herbs, but this is the first to have passed preclinical research, to be approved by the Ethical Evaluation Committee in Biomedical Research of the Ministry of Health, and allowed to enter clinical trials to treat Covid-19,” said Chu Hoang Ha, vice president of VAST’s Institute of Biotechnology and head of the Institute of Biotechnology.
Nguyen Ngo Quang, deputy head of the ministry’s Administration of Science Technology and Training, said the ministry evaluated the product at the preclinical stage, before clinical evaluation.
“The ministry hopes the clinical research would be completed by the year’s end. It will take about two-three months for human trials to be completed, before a mid-term assessment summarizes the test results,” said Quang.
As the drug is derived from herbs, the ministry has accepted to deploy clinical trials from phase two, which means testing it on 60 people with mild Covid-19 symptoms to measure its safety and ability to reduce the viral load.
At the end of this stage, the Ministry of Health would decide on licensing the drug.
“It is expected that by the end of 2021, the drug could be licensed for sale if there are satisfactory test results,” Quang said, adding that currently, the number of Covid-19 patients with mild symptoms is high and that it is therefore easy to recruit subjects to participate in the trial.
Previously, the research team had tested the medicine on rabbits, having them take the drug sample continuously for 28 days with two doses of 0.378 tablet per kilo of rabbit per day, which corresponds to the maximum dose for humans at 6 tablets/person/day, and 1.133 tablets/kilo rabbit/day (three times higher than the maximum dose for humans).
As a result, the test sample did not affect the weight, body condition, and movement of rabbits.
Biochemical indicators evaluating liver and kidney function showed there were no abnormalities in the rabbit’s internal organs and no histopathological damage to their livers, kidneys and lungs.
Preclinical trial results have demonstrated that at a concentration of 50 ug/ml, Vipdervir has the ability to inhibit the growth of nCoV and has an immune-enhancing effect on tested animals.
If the research is successful, as it appears to be, the relevant studies will be carried out to master the manufacturing technology of Vipdervir and turn it into a new tool in the anti-Covid-19 treatment.
The VAST’s Institute of Biotechnology, the Vinh Gia Pharmaceutical JSC and the Vietnam Chemical Pharmaceutical JSC are participating in the research.