WHO's decision to resume HCQ clinical trial a step in right direction, say experts

Terming WHO's decision to resume testing of hydroxychloroquine as a potential treatment for COVID-19 in its global clinical trial "a step in the right direction", experts said any "positive outcome" of the exercise will be in the larger interest of the people globally.

The global heath body had earlier suspended the hydroxychloroquine (HCQ) arm of the clinical trials of experimental COVID-19 drugs over safety concerns. However on Wednesday, it recommended the trial to be continued following a review of safety data.

"On the basis of the available mortality data... the members of the Solidarity Data Safety Monitoring Committee unanimously agreed that there are no cogent reasons to recommend modifications of the protocol of the trail and advised that the trial should be continued as planned," the Executive Group of the Steering Committee of the Solidarity Trial wrote to all National Principal Investigators of the Solidarity Trial.

Welcoming WHO's decision, ICMR Director General Dr Balram Bhargava said, "ICMR and India have been firm on recommendations about the drug based on biological plausibility, in vitro data and case controlled studies.

"It is a time tested drug in use for decades. Any positive outcome from the clinical exercise will be in the larger interest of the people globally."

He had earlier said that no major side-effects of the anti-malarial drug hydroxychloroquine has been found in studies in India and its use can be continued as prophylaxis for COVID-19 under strict medical supervision.

AIIMS Director Dr Randeep Guleria said WHO's decision about resuming the HCQ arm of the clinical trial was "a step in the right direction towards larger public interest".

"Data from India both from AIIMS and ICMR shows a good safety profile. We did not find that this drug was causing significant cardiac toxicity and therefore it is good that WHO reviewed their data and reintroduced the drug in the trial.

"This is a drug which is less expensive, easily available and has been used widely for a long time with good safety data. It will be good if the medicine turns out be beneficial in some way in COVID-19 treatment," he said.

Dr Sheela Godbole, the National Coordinator of the WHO-India Solidarity Trial and Head of the Division of Epidemiology, ICMR-National AIDS Research Institute said the hydroxychloroquine arm of the Solidarity Trial alone was paused as the Solidarity Data Safety Monitoring Committee reviewed the data.

"Yesterday, the report of this committee was received and they advised that the trial should be continued as planned. Based on this, the Executive Group has restarted the hydroxychloroquine arm.

The world needs strong data from well-conducted randomised controlled clinical trials on the drug for treatment of COVID-19. We are glad that we can begin the hydroxychloroquine arm again," Dr Godbole said.

Besides hydroxychloroquine, three more treatment protocols -- remdesivir, comibnation of lopinavir and ritonavir, and lopinavir and ritonavir with Interferon beta-1a -- are being evaluated during the clinical trials at selected hospitals in the world.

The Indian Council of Medical Research (ICMR) in its revised advisory on May 22 recommended use of the drug as a preventive medication for COVID-19 for asymptomatic healthcare workers in non-COVID hospitals and frontline staff on surveillance duty in containment zones and paramilitary/police personnel involved in coronavirus infection related activities.

The drug is also recommended for all asymptomatic healthcare workers involved in containment and treatment of COVID-19 and household contacts of laboratory confirmed cases.

The Union health ministry on March 31 had also recommended use of hydroxychloroquine in combination with azithromycin on COVID-19 patients who are in severe condition requiring ICU management.

Follow our full coverage of the coronavirus pandemic here.