Vietnamese herbal Covid medicine approved for clinical trials

The medicine candidate, called Vipdervir, is used to prevent and heal diseases caused by the RNA virus, a virus which has RNA as its genetic material, especially the novel coronavirus (SARs-CoV-2).

"Vipdervir is made entirely from herbs, contains active ingredients capable of blocking target molecules involved in the invasion and replication of the coronavirus, and contains active ingredients that activate cells in the immune system to help strengthen the patient's resistance," said Associate Professor and Doctor Le Quang Huan, a high-level researcher at the Institute of Biotechnology under VAST.

Currently, Vipdervir products are prepared in the form of hard capsules.

Bottles of Vipdervir, a Vietnamese herbal Covid-19 medicine that has been approved for clinical trials. Photo courtesy of the Institute of Biotechnology.

"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 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.

After that, the process would move to phase three to have the drug tested on 200 patients, evaluating the drug’s effect between different patients.

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 candidate 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.

Associate Professor and Doctor Le Quang Huan (C) and his colleagues at the Institute of Biotechnology under the Vietnam Academy of Science and Technology. Photo courtesy of the institute.

Huan and his colleagues at the Institute of Biotechnology had started studying herbs to support Covid-19 treatment from the beginning of the pandemic.

Having experience in processing herbal products for cancer treatment and a number of other supportive drugs, he has taken advantage of previous studies in the process of finding drugs to treat Covid-19.

The research team has used many technologies to screen for the main active ingredients in herbs that are effective in preventing the invasion and proliferation of nCoV.

Then, the team used biotechnology to identify and create combinations of herbs containing active ingredients that bring the highest therapeutic effect. The herbal ingredients of the product include many different types such as green chiretta, fish mint, Baikal skullcap, cloves, ginger, licorice, among others.

Vipdervir has been evaluated for acute toxicity at the Central Institute for Drug Control and Hanoi Medical University, for its ability to inhibit the H5N1 virus at the Institute of Biotechnology, to inhibit coronavirus at the National Institute of Hygiene and Epidemiology and its ability to increase immunity at Hanoi Medical University.