Remdesivir found ineffective; India to reassess coronavirus treatment protocol

In March, WHO and its partners started a large-scale trial — spanning over 400 hospitals in more than 30 countries and involving over 11,300 participants — to find an effective drug against the virus, that has so far killed 1,109,130 globally.

Four drugs, namely Remdesivir, Hydroxychloroquine, Lopinavir/Ritonavir, and Interferon (along with Rotinavir and Lopinavir) were administered.

Remdesivir, which was seen as promising, also failed.

2,743 patients were given Remdesivir. Of them, 301 died. Moreover, of the 2,708 under control group, 303 died within a span of 28 days.

"It (the trail) found that all 4 treatments evaluated (Remdesivir, Hydroxychloroquine, Lopinavir/ritonavir, and Interferon) had little or no effect on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalized patients," WHO's statement, published on the website, read.

Notably, WHO's findings miffed Gilead Sciences, an American biopharmaceutical firm, that developed and patented the promising drug.

"We are concerned that the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design," the firm said.

Chairperson of Biocon, Kiran Mazumdar Shaw, also described WHO's process as flawed.

Meanwhile, buoyed by the study's findings, India has decided to approach coronavirus treatment differently.

Dr. Balram Bhargava, Director-General of Indian Council of Medical Research (ICMR), told HT, "We will be revisiting the clinical management protocol in the light of new evidence before us."

Hydroxychloroquine's off-label use for moderately-ill coronavirus patients was approved by India's drug regulator, while Remdesivir was approved for "emergency use authorization."

Evidently, experts raised pertinent questions after WHO's findings.

Referring to the trial involving over 1,000 patients in US, Dr. Srinath Reddy, President of the Public Health Foundation of India, told IE, "The numbers were relatively small for a clinical trial — and it turned out that the Remdesivir group had better prognostic indicators than the control arm."

But he didn't dismiss the study, altogether.

Dr. Reddy said the main objective was to conclude the effectiveness of drugs. In this context, they found an answer.

"There are certain soft end points like if there are any particular subsets that benefit more; like Americans are saying that it cut shorts the recovery time etc., which we will get to know as the trial is ongoing," he told HT.