WHO Halts Hydroxychloroquine, Lopinavir/ritonavir Trials For COVID-19 Treatment

WHO Halts Hydroxychloroquine, Lopinavir/ritonavir Trials For COVID-19 Treatment

The World Health Organization (WHO) on Saturday said it has accepted recommendations to discontinue the trials of hydroxychloroquine and lopinavir/ritonavir arms as potential COVID-19 treatment.

The recommendations were from Solidarity Trial’s International Steering Committee established by WHO to find an effective COVID-19 treatment for hospitalized patients.

The novel coronavirus (COVID-19), which broke out about six months ago, has infected over 11 million and killed about 553, 639.

The effectiveness of hydroxychloroquine as a treatment for the disease had generated controversy especially after U.S. President Donald Trump touted the drug as a miracle cure for the disease.

WHO is also stopping the trials on the HIV antiretroviral drugs, lopinavir/ritonavir, because it failed to reduce COVID-19 mortality.

Six months after the new coronavirus was first reported in China, there is yet no acceptable and official cure endorsed for the treatment or an approved vaccine for the prevention of the disease.

Scientists across the world in collaboration with WHO and research agencies have been working tirelessly to find a cure for the disease whose pattern of transmission is still not well known.

Trials Stopped

According to a statement released by WHO, the International Steering Committee formulated the recommendation in light of the evidence for hydroxychloroquine vs standard-of-care and for lopinavir/ritonavir vs standard-of-care from the Solidarity trial interim results, and from a review of the evidence from all trials presented at the July 1 to 2 WHO Summit on COVID-19 research and innovation.

The solidarity trial refers to large multi-country trials that the agency is leading.

The interim trial results from the study show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalised COVID-19 patients when compared to standard of care.

“Solidarity trial investigators will interrupt the trials with immediate effect.

“For each of the drugs, the interim results do not provide solid evidence of increased mortality,” it said.

The halt in hydroxychloroquine trial is at odds with a recent study by the Henry Ford Health System which found that coronavirus patients treated early with hydroxychloroquine were 50 per cent less likely to die.

WHO explained that while there was no ‘solid evidence’ of increased mortality for hospitalised patients given the drugs, there were ‘some associated safety signals in the clinical laboratory findings’ of an associated trial

“There were some associated safety signals in the clinical laboratory findings of the add-on Discovery trial, a participant in the Solidarity trial.

“These will also be reported in the peer-reviewed publication,” it stated.

WHO said the decision applies only to the conduct of the solidarity trial in hospitalised patients and does not affect the possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalised patients or as pre- or post-exposure prophylaxis for COVID-19.

The interim solidarity results are now being readied for peer-reviewed publication.

Vaccine not ready

WHO director-general Tedros Ghebreyesus told reporters on Friday during a virtual press conference that nearly 5,500 patients in 39 countries had been recruited so far into its clinical trials

He added that some 18 experimental COVID-19 vaccines are being tested on humans among nearly 150 treatments under development.

WHO’s Mike Ryan also said on Friday that it would be unwise to predict when a vaccine could be ready.