Solidarity trial: WHO suspends allocation of patients to HCQ arm for now
In the light of emerging evidence, the World Health Organization has temporarily suspended allocation of patients in the hydroxychloroquine arm of the Solidarity Trial. A call will be taken once the existing evidence has been reviewed. Patients who were randomised to the HCQ arm earlier will complete their treatment. The decision was taken in an extraordinary meeting of the executive group of the Solidarity Trial on Sunday.
The decision comes in the wake of a series of trials being reported which did not find any benefit of HCQ being used in Novel Coronavirus Disease (Covid-19) patients. India, however, continues to use the drug for prophylaxis among health and other frontline workers and family members of Covid positive patients. It, along with azithromycin, continues to be India’s drug of choice for treatment of severe cases.
The executive group of the Solidarity Trial reportedly decided to err towards a “conservative approach” and implement a temporary suspension of random allocation to the hydroxychloroquine arm within the Solidarity Trial while the review of evidence occurs. This was done without any associated judgement on whether or not there is evidence of harm, benefit or lack of benefit caused by hydroxychloroquine. The extensive review of the evidence will be conducted by mid-June.
Among the evidence considered while taking the decision is a study, published in The Lancet last week, that said that while no benefit was found for Covid, the known side-effect of HCQ of fluctuations in the heart rate was noted. “We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19,” the researchers reported in The Lancet. Another study earlier this month in The BMJ, too, said that while the drug did not seem to give significant positives in COVID patients, “Adverse events were higher in hydroxychloroquine recipients than in non-recipients.”
However, in a small study published in the International Journal of Antimicrobial Agents on March 17, French scientists reported: “Twenty cases were treated in this study and showed a significant reduction of the viral carriage at D6-post inclusion compared to controls, and much lower average carrying duration than reported of untreated patients in the literature. Azithromycin added to hydroxychloroquine was significantly more efficient for virus elimination.
Hydroxychloroquine is a drug used in the treatment of autoimmune diseases such as rheumatoid arthritis and lupus. It is also used for the prevention of malaria and its treatment; it is a derivative of the anti-malaria drug chloroquine. Lately, its role is being investigated in the treatment and prevention of Covid-19.
The Solidarity Trial is a multi-country trial anchored by WHO in which the efficacy of various therapeutic options such as remdesivir, Hydroxychloroquine, rionavit and lopinavir are being tested.