WHO to resume hydroxychloroquine clinical study

The World Health Organization (WHO) will resume a clinical trial to study the effects of the anti-malaria drug touted by President Trump as a treatment for COVID-19 after pausing it due to safety concerns, the organization said Wednesday.

Enrollment in the hydroxychloroquine arm of the Solidarity Trial was temporarily paused last week after an article in The Lancet medical journal warned about the safety of the drug. 

The authors of the journal article tied hydroxychloroquine to higher mortality rates in hospitalized patients with COVID-19, as well as an increased risk of a dangerously abnormal heart rate. 

As a result, the WHO decided to pause the clinical study and allow the trial’s data safety monitoring board to analyze the results and determine if there were any safety concerns. 

However, experts have since raised concerns about the accuracy of the data used in The Lancet study, which was an observational analysis of a database, rather than a clinical trial. The data was supplied by a small company called Surgisphere.

The company has provided data for multiple studies on COVID-19 co-authored by its chief executive, including in the New England Journal of Medicine, but has so far failed to adequately explain its data or methodology. 

On Tuesday, the editors of The Lancet and the New England Journal of Medicine issued separate “expressions of concern” regarding the studies and said independent reviews of the data have been launched by the co-authors of both studies.

On Wednesday, WHO Director-General Tedros Adhanom Ghebreyesus said the safety committee reviewed mortality data and decided “there are no reasons to modify the trial protocol.” 

Tedros said the WHO will communicate with the principal investigators in the trial about resuming the hydroxychloroquine arm. 

So far, more than 3,500 patients have been recruited for the Solidarity Trial in 35 countries.

The trial is examining four separate options to help find an effective treatment for COVID-19. 

There is no clinical evidence to support the use of hydroxychloroquine for either treating or preventing COVID-19, but the WHO trial could help answer that question. 

In the U.S., a 2,000-person trial launched by the National Institute of Allergy and Infectious Diseases is also underway.

The Food and Drug Administration has warned that hydroxychloroquine should not be used outside of hospitalized patients or clinical trials for COVID-19, but the use of the drug has become a partisan flashpoint. 

Trump said last month that he has taken it as a prophylactic against the coronavirus.