A study from France said that the anti-malarial hydroxychloroquine and antibiotic azithromycin combination helped 78 out of 80 patients analysed. So, does that say India has got it right?

NEW DELHI: Anti-malaria drug hydroxychloroquine seems to be emerging as medicine of choice for treating COVID-19 patients in the absence of a more targeted treatment yet, but there is little empirical evidence so far to conclude it really works in patients afflicted with the novel coronavirus.

The renewed focus on the drug comes after US President Donald Trump on Sunday in a telephonic conversation with PM Narendra Modi reportedly asked him to remove the export ban on hydroxychloroquine a day after India, its biggest manufacturer, declared it won't send the medicine outside.

In India, the drug along with antibiotic azithromycin was recently included in the clinical management guideline for COVID-19 patients - replacing anti-HIV drugs Lopinavir, Ritonavir - issued by the Union Health Ministry and the Indian Council of Medical Research with the rider that the two drugs should be given to only those needing ICU care.

"These drugs should be administered under close medical supervision, with monitoring for side effects including QT interval," the guidelines said as the drug, also used in the treatment of auto-immune diseases lupus and rheumatoid arthritis, may cause cardiotoxicity effects.

The government also said that these medications are presently not recommended for children less than 12 years, pregnant and lactating women.

"These guidelines are based on currently available information and would be reviewed from time to time as new evidence emerges," the ministry said while issuing the guideline.

Sources said that the revision had come as a study published in the New England Journal said that the anti-HIV drug combination did not work in 199 patients analysed, while another study from France said that the anti-malarial and antibiotic combination helped 78 out of 80 patients analysed.

There was another independent study from China to support hydroxychloroquine-Azithromycin combination.

Additionally, the government had said that hydroxycholoroquine should be taken by healthcare workers treating COVID-19 patients and close contacts of those who have tested positive in order to prevent the infection. No evidence, however, was cited for this endorsement.

In the daily briefing on the outbreak, the government clarified on Monday that since there was limited evidence on hydroxycholoroquine so far, it was not being recommended for public use yet. This statement came even as reports have emerged that many people, including doctors, were taking the drug prophylactically leading to its shortage in the market.

ICMR, as per available information, has not started any randomised clinical trials to assess the efficacy of the drug in the country.

Experts meanwhile said that the government guidelines related to the anti-malarial drug are "contradictory".

"The government, on one hand, asks the drug, along with Azithromycin to be used in severely ill patients and on other hand asks certain high-risk groups to use it prophylactically — this is a clear contradiction," said Dr Anupam Singh, an infectious disease expert with Santosh Institute of Medical Sciences in Ghaziabad.

He added that in most states, however, the drug is being used even in mild and moderately ill COVID-19 patients. "We have seen that its too late if the drug is used in very sick coronavirus patients," he added.