Tuesday, June 16, 2020

WHO to resume clinical trial of hydroxychloroquine on COVID-19 patients

The controversial anti-malarial drug hydroxychloroquine (HCQ) is making headlines again. The World Health Organisation (WHO) on Wednesday said that it will resume the solidarity trial of HCQ for the potential treatment of coronavirus disease. A few days back, the Organisation had implemented a temporary pause of the WHO-backed HCQ trials after a large-scale study flagged that the drug could cause more fatalities among COVID-19 patients. The study was published in the Lancet medical journal on May 22.


More than two months back, the WHO had initiated the Solidarity Trial to evaluate the safety and efficacy of four drugs and drug combinations against COVID-19, which include HCQ. After the Lancet study warned against usage of HCQ for treatment of COVID-19 patients, the Executive Group of the Solidarity Trial agreed to review all evidence available globally to evaluate the potential benefits and harms from this drug. The Executive Group of the Solidarity Trial include members from 10 participating countries.


HCQ returns to the solidarity trial


At a press conference in the WHO headquarters in Geneva on Wednesday, Director General Tedros Adhanom Ghebreyesus announced that they will continue all arms of the solidarity trial, including hydroxychloroquine.


“On the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol. The Executive Group received this recommendation and endorsed continuation of all arms of the solidarity trial, including hydroxychloroquine,” IANS quoted the WHO chief as saying.


Ghebreyesus noted the decision to temporarily suspend the trail was taken as a precaution while the safety data was reviewed. He also said that the Data Safety and Monitoring Committee will be closely monitoring the safety of all therapeutics being tested in the solidarity trial.


For the solidarity trial, more than 3,500 patients have been recruited in 35 countries.


HCQ linked to increased mortality rate


Hydroxychloroquine has been highly touted as a potential treatment and prevention measure against COVID-19. US President Donald Trump also had strongly advocated the use of HCQ and called it a “game-changer”. He even revealed in a media briefing last month that he is taking the drug as a preventive measure against COVID-19 infection.


However, the Lancet study had revealed increased number of deaths in patients treated with hydroxychloroquine in hospitals around the world. Based on their finding, the scientists had warned that hydroxychloroquine and its older version, chloroquine, should no longer be given to COVID-19 patients except in proper research settings. They noted while these drugs are fairly safe for malaria treatment, COVID-19 is a very different disease.


As part of their study, the scientists evaluated data of more than 96,000 COVID-19 patients in 671 hospitals, taking one of the anti-malaria drugs, with or without an antibiotic such as azithromycin, between 20 December and 14 April.


The results suggested that death rate was higher among patients taking the drugs than those who were not given the medication. They found that one in six of those taking one of the drugs died and many patients treated with hydroxychloroquine also developed heart irregularities.