Industry-led studies should answer hydroxychloroquine doubts

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It is President Trump’s drug of choice, at least when it comes to Covid-19, but there is little firm evidence around the effectiveness of hydroxychloroquine. Clinical studies of the the 65-year old antimalarial have proliferated, however: according to Evaluate Vantage research there are 102 active trials of chloroquine and the antibiotic azithromycin in Covid-19. The vast majority have academic sponsors, and the results to emerge so far are hard to interpret, owing to small sample sizes and lack of controls. This could change: yesterday Novartis pledged to start a phase III, double blind, randomised, placebo-controlled 440-patient study testing hydroxychloroquine as a monotherapy and in combination with azithromycin. This will be one of only five industry sponsored studies of the drug; Sanofi has listed three trials. It is remarkable that commercial companies should chose to throw money at an off-patent drug that they have effectively pledged to give away. However, given the hype and hope that is already driving widespread use of chloroquine and hydroxychloroquine, and the risk of serious side effects that can include arrhythmia and death, a more definitive answer about its role will provide much needed clarity.

Industry-sponsored clinical trials treating Covid with hydroxychloroquine
Sponsor/collaborators Status Trial design Phases Trial ID
Novartis Not known  Hydroxychloroquine v Hydroxychloroquine + azithromycin v placebo Phase III Not known 
Sanofi Recruiting Hydroxychloroquine SAR321068 v placebo Phase I NCT04333654
Sanofi/National Institute of Respiratory Diseases, Mexico Recruiting Hydroxychloroquine v placebo Phase III NCT04315896
Sanofi/National Institute of Respiratory Diseases, Mexico Recruiting Hydroxychloroquine v placebo Phase III NCT04318015
Bukwang Pharmaceutical Not yet recruiting Clevudine v hydroxychloroquine Phase II NCT04347915
Source: clinicaltrials.gov.

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