Novartis to sponsor large clinical trial of hydroxychloroquine in hospitalized COVID-19 patients
- Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial of hydroxychloroquine in hospitalized patients with COVID-19 disease
- Trial is designed and implemented quickly to address the need for science-based investigation following early preclinical and clinical evidence1,2,3?that hydroxychloroquine may help hospitalized patients with COVID-19 disease??
- Company will also make its hydroxychloroquine intellectual property available to support broad access if medicine is approved for COVID-19?
- Study complements Novartis commitment to donate up to 130 million doses of hydroxychloroquine globally to support the COVID-19 pandemic response
- Novartis has?a?broad COVID-19 research and development commitment, including multiple large sponsored and investigator initiated clinical trials of its medicines
- Gautret et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: Results of an open-label, non-randomized clinical trial. International Journal of Antimicrobial Agents. In press 17 March 2020. DOI: 10.1016/j.ijantimicag.2020.105949
- Wang, M. et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 30, 269?271 (2020).
- https://www.nature.com/articles/s41421-020-0156-0
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d22f0a8-170b-4c3e-8c2e-a5cf64b9958b
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Novartis Media Relations E-mail:?media.relations@novartis.com