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A few weeks into solidarity trial of hydroxychloroquine for the treatment of COVID-19, the World Health Organisation (WHO) has suspended the process.
It hinged its decision to temporarily halt the test trial of the drug on safety concerns.
This is based on a report published by Lancet, which indicated that more people are dying from the use of the drug to combat the pandemic.
Announcing the decision in an online briefing on Monday, WHO’s Director-General Tedros Adhanom Ghebreyesus 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 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.”
Hydroxycholoroquine has been touted by United States President Donald Trump and others as a possible treatment for the disease caused by the novel coronavirus. The U.S. President has said he was taking the drug to help prevent infection.
Dr. Mike Ryan, head of the WHO emergencies programme, said the decision to suspend trials of hydroxychloroquine had been taken out of “an abundance of caution”.
Over 400 hospitals in 35 countries are actively recruiting patients and nearly 3,500 patients have been enrolled from 17 countries.
Five states – Lagos, Ogun, Kaduna, Sokoto, Kano and the Federal Capital Territory (FCT) – have signed up to participate in the WHO’s solidarity trial to help find an effective treatment for COVID-19.
The WHO also warned that countries where coronavirus infections are declining could still face an “immediate second peak” if they let up too soon on measures to halt the outbreak.
The world is still in the middle of the first wave of the coronavirus outbreak, WHO emergencies head Dr Mike Ryan told an online briefing, noting that while cases are declining in many countries, they are still increasing in Central and South America, South Asia and Africa.
Ryan said epidemics often come in waves, which means that outbreaks could come back later this year in places where the first wave has subsided. There was also a chance that infection rates could rise again more quickly, if measures to halt the first wave were lifted too soon.
“When we speak about a second wave classically what we often mean is there will be a first wave of the disease by itself, and then it recurs months later. And that may be a reality for many countries in a number of months’ time,” Ryan said.
“But we need also to be cognizant of the fact that the disease can jump up at any time. We cannot make assumptions that just because the disease is on the way down now it is going to keep going down and we are get a number of months to get ready for a second wave. We may get a second peak in this wave.”
He said countries in Europe and North America should “continue to put in place the public health and social measures, the surveillance measures, the testing measures and a comprehensive strategy to ensure that we continue on a downwards trajectory and we don’t have an immediate second peak.”
Many European countries and U.S. states have taken steps in recent weeks to lift lockdown measures that curbed the spread of the disease but caused severe harm to economies.
The WHO boss added: “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.”