Another blow for hydroxychloroquine, as Novartis stops COVID-19 study
Citing recruitment difficulties that render trial completion unfeasible, Novartis has discontinued its hydroxychloroquine study for COVID-19. The announcement is the latest in a series of setbacks for the malaria drug in the indication.
Novartis AG (NYSE:NVS; SIX:NOVN) announced on Friday that acute enrollment difficulties had made infeasible the completion of the randomized, controlled Phase III trial to treat hospitalized COVID-19 patients with hydroxychloroquine. The pharma, which started the study in May, said no safety issues have been reported and efficacy had not been determined yet.
Novartis said it will continue to supply the drug for investigator-initiated studies and to governments upon request.
The trial stop comes two days after the WHO stopped, for the second time, the hydroxychloroquine arm of its SOLIDARITY trial. The organization said on Wednesday that the malaria drug does not result in the reduction of mortality in hospitalized COVID-19 patients, based on data from its master protocol trial and the U.K.’s RECOVERY trial (see “WHO Let the HCQ Out”).
The University of Oxford’s June 4 hydroxychloroquine readout from RECOVERY, also a master protocol study, had found that the drug failed to benefit hospitalized COVID-19 patients (see “Fresh Doubt on Hydroxychloroquine”).
RECOVERY’s data had also been cited by FDA when it rescinded an Emergency Use Authorization for hydroxychloroquine and chloroquine on Monday (see “FDA Revokes Chloroquine authorizations”).
At least 50 trials are still evaluating hydroxychloroquine, according to BioCentury’s COVID-19 Resource Center.