The RECOVERY trial, in the U.K., has found no clinical benefit from the use of hydroxychloroquine in hospitalized patients with COVID-19.
The RECOVERY trail which is the large randomized controlled trial in the U.K. began in the march. This trail has enrolled over 11,000 patients.
It is a dynamic trial assessing five candidate drugs and convalescent plasma therapy for treating COVID-19 in patients in U.K. hospitals.
The trial investigators found that there was no significant benefit in mortality reduction in the intervention group, which was the primary objective.
It then came to light that the drug did not have the desired beneficial effects.
“We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalized with COVID-19. We have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the RECOVERY Trial with immediate effect,” a June 5 press release says.
According to the release, a total of 1,542 patients were randomized to receive hydroxychloroquine for 10 days while 3,132 patients in the control arm received only standard care.
The researchers found that there was “no significant difference in the primary endpoint of 28-day mortality”. While mortality was 25.7% in the intervention group, 23.5% in the control group, which is not statistically significant.
There was no evidence of beneficial effects in-hospital stay duration and other endpoints, either.
The primary outcome was the reduction in all-cause mortality within 28 days of randomization.
The secondary outcomes measured were to assess any reduction in duration of hospital stay and need for and duration of ventilator or ECMO within 28 days and up to six months after randomization.
“These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalized with COVID-19,” the release says. The researchers will soon make the results available.
Peter Horby, Professor of Emerging Infectious Diseases and Global Health at the Nuffield Department of Medicine, the University of Oxford, and Chief Investigator for the trial says in the release that “Hydroxychloroquine and chloroquine have received a lot of attention and have been used very widely to treat COVID patients despite the absence of any good evidence. The RECOVERY trial has shown that hydroxychloroquine is not an effective treatment in patients hospitalized with COVID-19,”
Deputy Chief Investigator Martin Landray from the University of Oxford says: “There has been huge speculation and uncertainty about the role of hydroxychloroquine as a treatment for COVID-19, but an absence of reliable information from large randomized trials. The preliminary results from the RECOVERY trial are quite clear — hydroxychloroquine does not reduce the risk of death among hospitalized patients with this new disease.”
“The RECOVERY trial, in addition to the signals from other studies we have received so far, is enough to convince me to not offer hydroxychloroquine to hospitalized patients,” Nahid Bhadelia, a physician at Boston Medical Center, told Science. Prof. Landray added to this, saying: “If you, your spouse, your mother gets admitted to hospital and is offered hydroxychloroquine, don’t take it”.
Another trial found that hydroxychloroquine drug was not effective even as post-exposure prophylaxis in asymptomatic participants who have had high-risk exposure with a confirmed COVID-19 case. Nearly 88% (719 of 821 participants) had such high-risk exposure. The results of the trial published in The New England Journal of Medicine found that the incidence of COVID-19 illness was not statistically significant in the group that received the drug compared with the control group. While 49 of 414 (11.8%) participants who received the drug developed illness, 58 of 407 (14.3%) participants who got the placebo fell ill. Side-effects were more in the intervention group but no serious adverse events were reported.