The clinical trial for Favipiravir is being undertaken in India.
New Delhi: Scientists and health experts across the world are working day and night to find a cure for the Covid-19 pandemic. At last count, at least 140 clinical trials that are in phase II and phase III are being conducted by various countries. Out of these 140, 67 clinical trials have reached phase III.
Phase III in clinical trial is referred as the phase in which the drug is administered to a large number of people to expand the scope of its study for effectiveness and safety of the drug. The next step, if the trial is successful, is to apply for necessary permission from drug controllers and start the commercial production of the vaccine or the drug.
Out of these 67 advanced-level clinical trials, 23 of them are being carried out in the United States. Four such research have reached phase III in China. The other countries which are in the race to find a cure for Covid-19 and are at phase III include France, Canada, Spain, Russia, Germany, Italy, among some others.
The much talked about Remdesivir drug which was put under clinical trial by the Gilead Sciences company, United States of America, is in its last leg of human clinical trial and is expected to be put for FDA review by the end of this month. Gilead is conducting the phase III trial of the antiviral Remdesivir drug on more than 6,000 participants who are suffering from severe Covid-19. All the participants are believed to have responded positively to this drug, giving a sense of hope for treatment of the Covid-19 pandemic. These participants are spread across US, UK, Taiwan, Switzerland, Sweden, Spain, Singapore, Netherlands, South Korea, Japan, Italy, Hong Kong, Germany, France and China.
If the results of this trials are ‘positive’, the world is likely to have its first Covid 19 drug within one month.
Remdesivir is an antiviral drug that works by mimicking building blocks of the coronavirus’s genetic material, RNA. As the virus copies its RNA, Remdesivir takes the place of some building blocks, stopping or slowing viral replication. Another drug, Hydroxychloroquine—which is primarily an anti-malarial drug used in India—is being used in 25 phase III trials to find a cure for Covid-19
For example, in Brazil, 630 Covid-19 positive patients, who are admitted in hospital and are in a non-critical state, are being administered a combination of Hydroxychloroquine and Azithromycin as part of the clinical trial. This clinical trial which is in phase III stage is expected to be completed by August this year. The Massachusetts General Hospital, in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), among many other such institutes in the United States, is also carrying out a clinical trial to study the effectiveness of Hydroxychloroquine among adults hospitalised with Covid-19.
This trial, which is in its phase III stage, has administered the drug to 510 participants and is observing the patients for their response to the drug. This clinical trial is expected to be completed by July 2021. Using Hydroxychloroquine to treat Covid-19 is also being carried out by University of South Alabama on 58 participants. The trial which is in phase III is expected to give result by July 2020.
A phase II clinical trial in France is being carried out on 228 participants by using Tocilizumab drug, which is also known as Atlizumab, that is an immunosuppressive drug on Covid-19 patients. It is expected to get over by March 2021. Another phase III clincial trial is being carried out in France on 239 participants who are being administered Sarilumab, a human monoclonal antibody (a type of antibody made in the laboratory by combining a human antibody with a small part of a mouse or rat monoclonal antibody). It will get over by March next year.
Another combination of the antiviral drug called the Lopinavir and Ritonavir, which is often used as an antiretroviral medication to treat HIV/AIDS, has also being put under clinical trial by various countries to treat Covid-19 patients.
The University of Oxford is using a randomised trial to investigate whether treatment with either Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin or Tocilizumab, prevents death in patients with Covid-19. Over 12,000 patients have participated in this randomised clinical trial of the drug and this trial is likely to be completed by June 2021.
The Lopinavir/Ritonavir drug is also being put under clinical trial at the St. Michael’s Hospital in Toronto, Canada, where 1,220 Covid-19 patients are being administered this drug for a period of 14 days after the last exposure and their health parameters would be observed by the researchers to study the effectiveness or any side effects of the drug. This trial is likely to be completed only by March 2022. The Lopinavir/Ritonavir is also being put under clinical trial in countries like France, Saudi Arabia, Austria, United States, among many other countries.
Another drug that is being betted upon as a miracle drug in the treatment of coronavirus is the Favipiravir drug. The Favipiravir drug is also being used in at least 10 phase III clinical trials across the world. The clinical trial for this drug is also being undertaken in India.
The phase III clinical trial for Favipiravir, which is being conducted on 150 patients in India from hospitals like AIIMS Raipur, Dr Balabhai Nanavati Hospital in Mumbai, HCG Hospital in Gujarat, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute in Mumbai among others—where the patients will be administered oral dosage of the Favipiravir 200mg Tablets for the next 14 days—will begin from 20 May and will be completed within one year. The Favipiravir drug is an antiviral drug which is in use in countries like Japan for the treatment of influenza. The much talked about ChAdOx1 nCoV-19 developed by the Oxford University in UK is in the phase II stage of clinical trial. The study is being conducted to test the effectiveness of the vaccine against Covid-19 among healthy volunteers. Researchers at the Oxford University have selected 1,090 participants to take part in the clinical trial. Phase II of a research is described as trials during which preliminary data on whether a drug is working on people who have a certain condition/disease is gathered by giving drug samples to some and placebos to others.
ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to grow in humans.
The vaccination aims at making the body recognise and develop an immune response to the Spike protein that will help stop the SARS-CoV-2 virus from entering human cells and, therefore, prevent infection. The study on this vaccination is likely to be completed by May 2021. China is also working on developing a vaccine for Covid-19.
The Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China, is in phase II of clinical trial for developing a vaccine for Covid-19 called the vaccine for Covid-19 (Adenovirus Vector) or CTII-nCoV. This is going to be an Intramuscular injection. In this clinical trial, 500 randomised healthy participants have been selected where they have been administered this vaccine. This project is likely to be completed by January 2021.
The Russian Federation is also carrying out a clinical trial on vaccines. The BVRS-GamVac, intramuscular vaccine, which the Russians are studying, is an adenoviral-based vaccine against MERS and the aim of this study is to ascertain if this vaccine would also prove to be effective against SARS-nCOV2.
The study which is in Phase 2 of the clinical trial stage will be administered to 500 healthy participants and they will be observed for the next six months for effectiveness of the vaccine. This study is likely to be completed by January 2021.
Germany is also conducting clinical trial, which is at phase II stage for a vaccine (BNT162) against Covid-19 which is likely to be completed by August 2020. Around 200 healthy participants are being subjected to the BNT162 vaccine, which is an anti-viral RNA vaccine for active immunization against Covid-19.
In India, the Central Council for Research in Homoeopathy is also conducting clinical trials to study the effectiveness of Arsenicum Album 30C in prevention of Covid-19 in individuals residing in hotspots of red zones in Delhi. The test is being conducted on 10,000 individuals and has begun earlier this week. The researchers will observe if the patients in these red zones have had any effect of Arsenicum Album 30C helping them in preventing the virus.