The World Health Organization said it had “temporarily” suspended clinical trials of hydroxychloroquine as a potential treatment for COVID-19 being carried out across a range of countries as a precautionary measure.
The drug trial was suspended on grounds of safety concern. The decision came after the publication last week of a study in the Lancet indicating that using the drug on COVID-19 patients could increase their likelihood of dying, WHO chief Tedros Adhanom Ghebreyesus told a virtual press conference.
Tedros said that the executive group of the so-called Solidarity Trial, in which hundreds of hospitals across several countries have enrolled patients to test several possible treatments for the novel coronavirus, had as a precaution suspended trials using that drug.
Hydroxychloroquine is normally used to treat arthritis but pronouncement from public figures including US President Donald Trump — who announced last week he is taking the drug — has prompted governments to bulk buy the medicine.
Brazil’s health minister also recommended last week using hydroxychloroquine, as well as the anti-malarial chloroquine, to treat even mild COVID-19 cases.
The Lancet study found that both drugs can produce potentially serious side effects, particularly heart arrhythmia. And neither drug benefited patients hospitalised with COVID-19, according to a Lancet study, which looked at the records of 96,000 patients across hundreds of hospitals.
Tedros stressed Monday that the two drugs “are accepted as generally safe for use in patients with autoimmune diseases or malaria.”
WHO chief scientist Soumya Swaminathan meanwhile told Monday’s briefing that the WHO-backed Solidarity Trial had been looking only at the effects of hydroxychloroquine and not chloroquine.
The decision on suspending enrolment for trials using hydroxychloroquine was “a temporary measure”, she said.
“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.
On Friday, the Lancet published an observational study on hydroxycholoroquine and chloraquine and its effects on COVID-19 patients that have been hospitalised.
The authors reported that among patients receiving the drug, when used alone or with a macrolide, they estimated a higher mortality rate.
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.
The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the safety data is reviewed by the Data Safety Monitoring Board.
The other arms of the trial are continuing. This concern relates to the use of hydroxychloroquine and chloraquine 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 and solidarity.”
Over 400 hospitals in 35 countries are actively recruiting patients and nearly 3500 patients have been enrolled for trials in 17 countries. At the moment, five states in the country – Lagos, FCT, Ogun, Kaduna, Sokoto and Kano have signed up to participate in the WHO’s solidarity trial to help find an effective treatment for COVID-19.
