The World Health Organisation (WHO) will resume its trial of hydroxychloroquine for the treatment of coronavirus (COVID-19) patients, its Director-General, Dr Tedros Ghebreyesus, says.
Ghebreyesus, who stated this on the official twitter account of the UN health agency, said the hydroxychloroquine section of WHO’s Solidarity Trial can resume after being paused temporarily on May 25.
The trial’s Data Safety and Monitoring Committee had halted the study as a precaution in response to safety concerns raised by an observational study published in the Lancet.
Ghebreyesus said the Data Safety Monitoring Board’s review had been completed.
“Last week, the Executive Group of the Solidarity Trial decided to implement a temporary pause of the hydroxychloroquine arm of the trial, because of concerns raised about the safety of the drug.
“This decision was taken as a precaution while the safety data were reviewed. The Data Safety and Monitoring Committee of the Solidarity Trial has been reviewing the data.
“On the basis of available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol.
“The Executive Group received this recommendation and endorsed the continuation of all arms of the Solidarity Trial, including hydroxychloroquine.
“The Executive Group will communicate with the principal investigators in the trial about resuming the hydroxychloroquine arm,’’ he said.
The WHO director-general said the Data Safety and Monitoring Committee would continue to closely monitor the safety of all therapeutics being tested in the Solidarity Trial.
“So far, more than 3,500 patients have been recruited in 35 countries.
“WHO is committed to accelerating the development of effective therapeutics, vaccines and diagnostics as part of our commitment to serving the world with science, solutions and solidarity,’’ he said.
Meanwhile, Nigeria on May 27 declared that it would continue with hydroxychloroquine clinical trials on COVID-19 patients.
Prof. Mojisola Adeyeye, the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC), said the country would continue with the drug.
She said this would be in spite of the initial warning by WHO to discontinue using it.
“I do not know the data they’re looking at, whether it’s from the Caucasian population or from the African population.
“If the data they’re looking at, and the reason for suspending the trials, is from the Caucasian population, then it may be justified.
“But I don’t think we have data from the African population yet, because our genetic make-up is different.
“If medical doctors, research scientists, pharmacists and herbal experts work together, we should conclude the clinical trial in three to four months.
“The narrative may change afterwards. But for now, we believe in hydroxychloroquine,” she said.