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Why WHO has suspended hydroxychloroquine clinical trial on COVID-19 patients

A study has found increased number of deaths in patients treated with hydroxychloroquine.

WHO has implemented a temporary pause on its hydroxychloroquine trials. This world body will conduct a review of available data to evaluate the potential benefits and harms from this malaria drug.

Written by Longjam Dineshwori |Updated : May 26, 2020 2:47 PM IST

Many countries, including India, has been using anti-malaria drug hydroxychloroquine (HCQ) as a preventive medication for COVID-19, despite scant evidence about its efficacy against the virus. But the World Health Organization (WHO) on Monday announced that it has temporarily suspended clinical trials of the drug for COVID-19. The decision came after a large-scale study flagged that hydroxychloroquine offers no benefit to patients affected by the novel coronavirus, and that it could even increase their mortality risk. The Lancet medical journal had published the study results on May 22.

WHO's Director-General Tedros Adhanom Ghebreyesus on Monday said that the organisation has implemented a temporary pause of the WHO-backed HCQ trials while the safety data of the anti-malaria drug is being reviewed.

The Solidarity Trial

More than two months ago, WHO had initiated the Solidarity Trial, a plan to evaluate the safety and efficacy of four drugs and drug combinations against COVID-19, which include HCQ.

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The Executive Group of the Solidarity Trial, representing 10 of the participating countries, has agreed to review a comprehensive analysis of all evidence available globally to evaluate the potential benefits and harms from this drug - IANS quoted Tedros as saying.

Tedros, however, noted that the safety concern over the drug is related only to the use of HCQ and chloroquine in COVID-19. These drugs are already accepted as generally safe for use in patients with autoimmune diseases or malaria, he added.

HCQ is ineffective and harmful: Study

Hydroxychloroquine was highly touted as a potential treatment and prevention measure against COVID-19. US President Donald Trump had called it a potential "game changer". He even revealed in a media briefing recently that he is taking the drug as a preventive measure against COVID-19 infection.

Meanwhile, the study published online in the Lancet medical journal has found increased number of deaths in patients treated with hydroxychloroquine in hospitals around the world.

The scientists have also warned that hydroxychloroquine and its older version, chloroquine, should no longer be given to COVID-19 patients except in proper research settings. They acknowledged that these drugs are fairly safe for malaria treatment, but it said COVID-19 is a very different disease.

For the findings, they evaluated data of more than 96,000 COVID-19 patients in 671 hospitals, taking one of the drugs, with or without an antibiotic such as azithromycin, between 20 December and 14 April.

The results showed that death rate was higher among patients taking the drugs than those who were not given the medication. As per their data, one in six of those taking one of the drugs died. Among patients not taking the drugs, the death rate was one in 11.

The team also found that many people treated with hydroxychloroquine in combination experienced heart irregularities.

ICMR issues new guidelines for prophylacticuse of HCQ

Amidst the debate about the safety of hydroxychloroquine, the Indian Council of Medical Research (ICMR) has expanded the use of this drug as a preventive treatment against COVID-19.

On Saturday, the ICMR issued revised guidelines for prophylactic use of HCQ for a group of asymptomatic people, especially those who are on the frontline war against COVID-19.

The new guidelines recommended use of hydroxychloroquine as a preventive medication for:

  • asymptomatic surveillance workers deployed in containment zones and paramilitary/police personnel involved in COVID-19 related activities
  • asymptomatic household contacts of laboratory confirmed cases
  • asymptomatic healthcare workers involved in containment and treatment of COVID-19 and working in non- COVID hospitals

The apex health research body stated that the drug had some beneficial effect as a prophylactic option. However, it noted that the drug should be given on the prescription of a registered medical practitioner with an informed consent. It also cautioned that hydroxychloroquine should not be given to children under 15 years of age and pregnant and lactating women.

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