Pharmaceutical companies Novartis and Rising Pharmaceuticals are taking action to support the latest clinical trials exploring hydroxychloroquine as a treatment for the coronavirus disease 2019 (COVID-19).  

Novartis announced March 30 that it is donating 20,000 doses of hydroxychloroquine to the University of Washington for a COVID-19 PEP clinical trial, which is expected to provide approximately 2000 patients with a 14 post-exposure regimen.1

Earlier in March, Novartis committed to donating up to 130 million doses, or 200mg tablets, of generic hydroxychloroquine to support COVID-19 research. In previous studies, chloroquine (CQ) phosphate has demonstrated effective repression of the severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection, the cause of COVID-19 disease, in vitro. The drug has been described as an apparent “drug of choice” among several potential candidates for large-scale use due to its availability, proven safety record, and relatively low cost.1

Further, Rising Pharmaceuticals has announced a collaborative agreement with the Division of Infectious Disease and International Medicine at the University of Minnesota, Department of Infectious Disease on a clinical trial investigating hydroxychloroquine as a preventive treatment for COVID-19. The study will look at 1500 health care workers or household contacts exposed to COVID-19.2

Rising Pharmaceuticals manufactures hydroxychloroquine sulphate, USP tablets under an FDA approved drug application, in partnership with Laurus Labs.2

In previous studies, researchers have identified chloroquine and hydroxychloroquine as having activity against SARS-coronaviruses in nonhumans.2 David Boulware, MD, MPH, lead of the Rising Pharmaceuticals clinical trial, explained how clinical trials for new drugs like hydroxychloroquine are necessary for health care workers who are at risk of infection in an interview with Pharmacy Times®.

“We do not know if hydroxychloroquine has a clinical benefit for people with coronavirus, and that is why randomized clinical trials are needed to help inform policy,” Boulware said. “We are running 2 randomized clinical trials to test: first, if hydroxychloroquine can prevent infection in people who are exposed to someone with coronavirus infection. Second, if hydroxychloroquine can treat people with early infection with less than 4 days of symptoms.”

Hydroxychloroquine is indicated by the FDA for the prevention and treatment of certain types of malaria, as well as rheumatoid arthritis, and lupus.2 The drug was granted Emergency Use Authorization on March 28, 2020 for treatment of COVID-19.


REFERENCES
  1. Novartis donates 20,000 doses of hydroxychloroquine for COVID-19 PEP clinical trial [news release]. East Hanover, NJ; Sandoz: March 30, 2020. https://www.us.sandoz.com/news/media-releases/novartis-donates-20000-doses-hydroxychloroquine-covid-19-pep-clinical-trial. Accessed March 30, 2020.
  2. Rising Pharmaceuticals and Laurus Labs partner to support the University of Minnesota to explore the prophylaxis effect of hydroxychloroquine in essential health care workers [news release]. Hyderabad, India; March 27, 2020: Laurus Labs website. https://lauruslabs.com/Investors/PDF/PressReleases/LaurusLabsPressReleaseMarch272020.pdfAccessed April 2, 2020.