https://www.statnews.com/2020/06/03/who-resuming-hydroxychloroquine-study-for-covid-19/
By ANDREW JOSEPH @DrewQJoseph
JUNE 3, 2020
Tedros Adhanom Ghebreyesus, WHO's director-general
FABRICE COFFRINI/AFP VIA GETTY IMAGES
The World Health Organization is resuming a clinical trial exploring whether the malaria drug hydroxychloroquine can effectively treat Covid-19, after pausing enrollment in the study to review safety concerns about the drug.
The hydroxychloroquine investigation is just one arm of the agency’s Solidarity Trial, which is testing different therapies to determine which are beneficial in the disease caused by the novel coronavirus. The WHO last week temporarily suspended the hydroxychloroquine arm after a separate study published in the Lancet raised warnings about the drug’s safety.
Like the Lancet study, other observational studies had not found any apparent benefit for the drug in Covid-19. But the Lancet study prompted additional concerns because it found the drug was also associated with higher mortality.
Outside experts, however, have since questioned the sources and analysis of the patient data included in the Lancet study, which were provided by a little-known company called Surgisphere. They cited inconsistencies in the data — some of which have since been corrected — and a lack of transparency about which countries and hospitals provided the information.
The Lancet study led the WHO to pause the hydroxychloroquine study so the trial’s data safety monitoring board could analyze the results generated so far and see if any safety concerns were apparent.
At a press briefing Wednesday, Tedros Adhanom Ghebreyesus, WHO’s director-general, said the board reviewed the available mortality data and found “no reasons to modify the trial.” He said the WHO was telling the investigators involved in the study to resume their work.
More than 400 hospitals in 35 countries are participating in the Solidarity Trial, which involves thousands of patients.
By ANDREW JOSEPH @DrewQJoseph
JUNE 3, 2020
Tedros Adhanom Ghebreyesus, WHO's director-general
FABRICE COFFRINI/AFP VIA GETTY IMAGES
The World Health Organization is resuming a clinical trial exploring whether the malaria drug hydroxychloroquine can effectively treat Covid-19, after pausing enrollment in the study to review safety concerns about the drug.
The hydroxychloroquine investigation is just one arm of the agency’s Solidarity Trial, which is testing different therapies to determine which are beneficial in the disease caused by the novel coronavirus. The WHO last week temporarily suspended the hydroxychloroquine arm after a separate study published in the Lancet raised warnings about the drug’s safety.
Like the Lancet study, other observational studies had not found any apparent benefit for the drug in Covid-19. But the Lancet study prompted additional concerns because it found the drug was also associated with higher mortality.
Outside experts, however, have since questioned the sources and analysis of the patient data included in the Lancet study, which were provided by a little-known company called Surgisphere. They cited inconsistencies in the data — some of which have since been corrected — and a lack of transparency about which countries and hospitals provided the information.
The Lancet study led the WHO to pause the hydroxychloroquine study so the trial’s data safety monitoring board could analyze the results generated so far and see if any safety concerns were apparent.
At a press briefing Wednesday, Tedros Adhanom Ghebreyesus, WHO’s director-general, said the board reviewed the available mortality data and found “no reasons to modify the trial.” He said the WHO was telling the investigators involved in the study to resume their work.
More than 400 hospitals in 35 countries are participating in the Solidarity Trial, which involves thousands of patients.
