COVID-19: WHO Suspends Clinical Trial of Hydroxychloroquine, Cites Safety Concerns


Martins Ifijeh

The World Health Organisation (WHO) has suspended clinical trial of hydroxychloroquine following new data suggesting the drugs increase mortality among COVID-19 patients.

Announcing this Monday during a virtual meeting to mark Africa Day, the Director General, WHO, Dr. Tedros Ghebreyesus said the suspension was necessary in other to evaluate the safety data on the drugs as presented to the health body by the Data Safety Monitoring Board.

He said: “As part of our continued response to the pandemic globally, WHO continues to work aggressively on research and development.

“As you know, more than two months ago we initiated the Solidarity Trial to evaluate the safety and efficacy of four drugs and drug combinations against COVID-19.

“Over 400 hospitals in 35 countries are actively recruiting patients and nearly 3,500 patients have been enrolled from 17 countries. But on Friday, The Lancet published an observational study on hydroxycholoroquine and chloroquine and its effects on COVID-19 patients that have been hospitalised.”

The DG said the authors reported that among patients receiving the drug, when used alone or with a macrolide, they estimated a higher mortality rate.

He added: “The Executive Group of the Solidarity Trial, representing 10 of the participating countries, met on Saturday and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally.

“The review will consider data collected so far in the Solidarity Trial and in particular robust randomised available data, to adequately evaluate the potential benefits and harms from this drug.”

He explained that the executive group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the safety data was reviewed by the Data Safety Monitoring Board, stressing that the other arms of the trial were continuing.

Ghebreyesus said: “This concern relates to the use of hydroxychloroquine and chloroquine in COVID-19. I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria. WHO will provide further updates as we know more. And we will continue to work night and day for solutions, science,” he added.

Meanwhile, the DG commended the African continent for its push against the COVID-19 pandemic, adding that it has the least burden of the disease compared to other regions of the world.

He said: “So far, although around half of the countries in the region have community transmission, concentrated mainly in major cities, Africa is the least-affected region globally in terms of the number of cases and deaths reported to WHO.

“Africa has just 1.5 per cent of the world’s reported cases of COVID-19, and less than 0.1 per cent of the world’s deaths.

“Of course, these numbers don’t paint the full picture. Testing capacity in Africa is still being ramped up and there is a likelihood that some cases may be missed. But even so, Africa appears to have so far been spared the scale of outbreaks we have seen in other regions,” he said.