India studies efficacy of antimalarial drug on Covid-19
India has begun a demonstration study in around a 1,000 health workers and close contacts of positive coronavirus (Covid-19) cases on the efficacy of the anti-malaria drug, hydroxychloroquine, as a prophylactic drug against Covid-19.
“It is a proof-of-concept study that is being done to see how successful is a particular medicine in preventing high-risk people from getting infected. What we are doing different from the studies done in other countries is that we are checking whether it can work as a prophylactic medicine, whereas everywhere else it was given to positive patients as a treatment option with somewhat positive results,” says Dr Raman R Gangakhedkar, chief, epidemiology division, Indian Council of Medical Research (ICMR).
The dosage given to people in India is 400mg, twice a day, for one day, and subsequently 400mg once a week. The course is recommended for seven weeks.
“In positive patients, the medicine has shown to reduce the viral load, and our aim is to see whether it will prevent infection or not,” said Dr Gangakhedkar.
Last week, the government approved the “restricted” use of the drug for prophylaxis of Sars-CoV-2, the virus that causes Covid-19. The drug is approved in India for two categories that are asymptomatic healthcare workers involved in the care of suspected or confirmed cases of Covid-19; and asymptomatic household contacts of laboratory confirmed cases that live in close proximity with the patients and run the risk of getting infected.
According to sources, around 1,000 people have been put on the medicine as part of the study.
‘Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial,’ a study published on March 17 in the International Journal of Antimicrobial Agents, showed there was viral load reduction in Covid-19 patients.
“Despite its small sample size, our survey shows that hydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in Covid-19 patients and its effect is reinforced by azithromycin,” the paper says.
Most of the research on therapeutics against Covid-19 is being done around repurposing of old drugs for use as antiviral treatment because lack of knowledge on safety profile, side effects, drug interactions etc.
“Repurposing drug molecules is quicker rather than looking at developing a new drug altogether that can take years,” said Dr Balram Bhargava, director general, ICMR, in a briefing.
The ICMR is supervising the study and is closely monitoring people who are on medication. “We are generating our own data; since it is a small number, it is easy to monitor,” says Gangakhedkar.
Findings from these studies and other new evidence will guide any change in the recommendation.
However, since people had begun buying the drug over-the-counter, the government on Friday put it under the category of schedule H1 drug, meaning one would need a prescription to buy it.
“It is not prescribed for everyone as this medicine has its side effects. It can’t be given to people above 60 years of age or children under 15 years of age. People should understand it is being currently prescribed for a select group on an experimental basis. It is not recommended for everyone as a preventive drug,” says Dr Gangakhedkar.