A clinical trial of the antimalarial drug hydroxychloroquine in patients with coronavirus has been suspended due to safety concerns.
Hydroxychloroquine was introduced by President Donald Trump and even revealed that he had taken the drug for two weeks prophylactically.
But the World Health Organization (WHO) has expressed concern after a Lancet study released on Friday found higher death rates among COVID-19 patients who took the drug.
Therefore, the researchers said that they were suspending the use of hydroxychloroquine in Solidarity trial, which involves evaluating the safety and efficacy of four drugs and combinations of drugs against the virus.
“The executive group has set up a temporary break in the hydroxychloroquine arm as part of the Solidarity trial while the security data is being examined by the data security oversight committee,” the chief executive of the company said on Monday. ‘WHO, Tedros Adhanom Ghebreyesus.
However, other parts of the trial are continuing, including testing for an investigational drug, remdesivir, and combination therapy for HIV.
On Monday, the World Health Organization (WHO) announced that it was suspending the hydroxychloroquine arm from its trial due to safety concerns (file image)
WHO director-general Dr Tedros Adhanom Ghebreyesus (photo) said the decision came after a study found higher mortality rates among COVID-19 patients who took the drug on Friday
President Donald Trump said on Sunday that he had finished taking his two-week prescription for the antimalarial drug, which he had used as a prophylactic to ward off the virus.
“This concern relates to the use of hydroxychloroquine and chloraquine in COVID19,” said Dr. Tedros at the press conference.
“I would like to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria
“WHO will provide other updates, as we know more. And we will continue to work day and night for solutions, science and solidarity.
The organization previously recommended that hydroxychloroquine should not be used to treat or prevent coronavirus infections, except in clinical trials.
Dr. Mike Ryan, head of the WHO emergency program, said the decision to suspend testing for hydroxychloroquine was made “with great caution.”
Meanwhile, in the UK, the Principle trial examines hydroxychloroquine in patients aged 50 to 64 who have symptoms of COVID-19 and a chronic medical condition such as heart disease, asthma or cancer.
It is not known how many participants have registered, but testing is expected to continue in March next year
Last month, President Trump was among the first to speak in a lyrical way about the potential benefits of hydroxychloroquine for patients with coronavirus.
“It would be a gift from heaven, it would be a gift from God if it worked,” he said. “We are going to pray to God that it will work.”
He then repeated the claims on Twitter.
“HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance of being one of the greatest game changers in the history of medicine. FDA has moved mountains – Thank you! I hope they both do it (H works best with A, International Journal of Antimicrobial Agents), “he wrote on March 21.
The study Trump refers to comes from Marseille, France, where 30 patients were treated with hydroxychloroquine for 10 days in combination with azithromycin, an antibiotic.
Although very small, the study “showed a significant reduction in viral carriage” after six days and a “much shorter average transport time” than patients who received other treatments.
But weeks later, in a statement posted online, the International Society for Antimicrobial Chemotherapy (ISAC) addressed several new research concerns.
Officials say they discovered that the researchers excluded data from patients who were not responding well to treatment and did not specify what they meant when they said the patients were ” virologically healed ”.
Trump said last week that he has been taking the malaria drug for a week and a half to prevent the virus.
In an interview with Full Measure with Sharyl Attkisson aired on Sunday, Trump announced that he had finished taking his prescription.
“Finished, just finished,” said the commander-in-chief. “And by the way, I’m still here. To the best of my knowledge, here I am.
Trump has been criticized for repeatedly promoting the use of the coronavirus drug and urging people to try it.
A study published in The Lancet on Friday examined more than 96,000 people hospitalized with COVID-19, including those treated with hydroxychloroquine or its analog chloroquine.
The researchers found no benefit for patients with coronavirus taking the drugs.
In fact, patients were at a higher risk of death and heart rhythm problems than patients who had not received the drugs.
The authors suggested that hydroxychloroquine and chloroquine should not be used to treat COVID-19 outside of clinical trials until studies confirm their safety and effectiveness in these patients.
Hydroxychloroquine: what you need to know about the drug
Hydroxychloroquine was approved in the 1940s as a means of treating malaria. It is also prescribed to patients with arthritis and lupus.
Trump hailed “revolutionary” drugs and said, “It would be a gift from heaven, it would be a gift from God if it worked. “
However, the doctors insisted that the drug should not be used without further testing.
The US Food and Drug Administration (FDA) has also warned doctors about prescribing the drug to treat coronavirus outside of hospitals following reports of serious side effects, including irregular heart rhythms and death. in patients.
Preliminary results from a recent study of coronavirus patients in veteran hospitals in the United States have shown no benefit, casting more doubt on the drug’s effectiveness during the pandemic.
The Centers for Disease Control and Prevention (CDC) has removed guidelines from its website informing doctors about how to prescribe hydroxychloroquine.
Originally, the CDC web page read: “Although the optimal dosage and duration of hydroxychloroquine for the treatment of COVID-19 is unknown, some American clinicians have reported anecdotal reports. “
He now says, “There are no drugs or other therapies approved by the US FDA to prevent or treat COVID-19. “