One of the companies sponsoring a trial of a malaria drug once touted as a potential “game changer” in Covid-19 is stopping the study due to low recruitment.
Basel, Switzerland-based Novartis said Friday that it would discontinue its randomized, placebo-controlled Phase III trial of hydroxychloroquine – as a single agent and in combination with the antibiotic azithromycin – among patients with moderate to severe Covid-19.
The trial, which was designed to include 444 patients, had encountered “acute” enrollment changes that made it infeasible. The company said no safety issues had been reported, but the company said it was unlikely that the study would be able to collect meaningful data in a reasonable time frame to determine the drug’s efficacy. Nevertheless, Novartis said it would continue to supply the drug at the request of government agencies and also for investigator-initiated trials, provided that certain conditions are met and the drug is used with a nationally endorsed treatment protocol.
The drugmaker’s decision came the same week that the FDA revoked the emergency use authorization for hydroxychloroquine and the closely related chloroquine that it had granted in March. The EUA had allowed the drugs to be donated to the Strategic National Stockpile for use in certain hospitalized patients. However, the FDA said the revocation, made at the request of the Biomedical Advanced Research and Development Authority, was due to the view based on emerging data that the drugs were not likely to be effective.
Several studies have already shown the drug to not be effective in Covid-19. These include analyses of patients hospitalized in New York and, most recently, a randomized, placebo-controlled trial conducted by the University of Minnesota that tested whether hydroxychloroquine could prevent SARS-CoV-2 infection among people who had been exposed to the virus, known as post-exposure prophylaxis.
A search for clinical trials of Covid-19 in which hydroxychloroquine or chloroquine is being used turned up 254 hits worldwide. Of those, most are listed as recruiting or preparing to enroll participants, but 17 are listed as suspended, terminated or withdrawn.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Photo: Narinder Nanu, AFP, Getty Images
