Novartis discontinues hydroxychloroquine clinical trial based on slow enrollment, remains committed to pandemic research efforts

NovartisNovartis has made the decision to stop and discontinue its sponsored HCQ clinical trial for COVID-19 due to acute enrollment challenges that have made trial completion infeasible. The recruitment challenge facing our HCQ trial has made it unlikely that the clinical team will be able to collect meaningful data in a reasonable timeframe to determine the effectiveness of HCQ in treating patients with COVID-19. No safety issues have been reported, and there are no conclusions on efficacy from the study.

Novartis will continue to provide supply of HCQ for ongoing investigator-initiated trials (IITs) and upon government requests, as appropriate, where certain conditions are met and the medicine is used in accordance with a nationally endorsed treatment protocol. Researchers at Novartis continue to monitor ongoing guidance from health authorities on the further study of HCQ for COVID-19, as well as the decision by the US Food and Drug Administration to stop the emergency use authorization of HCQ for COVID-19 treatment. In addition, ongoing studies involving other Novartis treatments continue, as well as the newly announced support of a potential vaccine. Novartis also continues to collaborate to find answers for COVID-19 through various partnerships with multi-stakeholder external consortia.

Novartis wishes to thank all of the patients, their families, investigators and healthcare professionals who played a vital part in our HCQ clinical trial (CJWT629A12301, NCT04358081) for COVID-19.

More information about the Novartis response to COVID-19 is available on novartis.com/coronavirus.

About Novartis

Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world.

Most Popular Now

Johnson & Johnson announces European Commissio…

Johnson & Johnson (NYSE: JNJ) (the Company) announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Pur...

BioNTech and Pfizer initiate rolling submission to…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lea...

Vir Biotechnology and GSK announce global expansio…

Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Eff...

Johnson & Johnson initiates pivotal global Pha…

Johnson & Johnson (NYSE: JNJ) (the Company) announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, J...

COVID-19 Long-Acting AntiBody (LAAB) combination A…

AstraZeneca's long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,000 participants at sites in and outside th...

COVID-19 vaccine AZD1222 clinical trial resumed in…

The Phase I/II clinical trial for the COVID-19 vaccine AZD1222 has resumed in Japan after discussion with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). ...

Adequate levels of vitamin D reduces complications…

Hospitalized COVID-19 patients who were vitamin D sufficient, with a blood level of 25-hydroxyvitamin D of at least 30 ng/mL (a measure of vitamin D status), had a signif...

Gilead Sciences signs joint procurement agreement …

Gilead Sciences (Nasdaq: GILD) and the European Commission signed a joint procurement agreement (JPA) that will enable rapid and equitable access to Veklury® (remdesivir)...

Protective antibodies persist for months in surviv…

People who survive serious COVID-19 infections have long-lasting immune responses against the virus, according to a new study led by researchers at Massachusetts General ...

Potential COVID-19 vaccines not affected by domina…

Vaccines currently being developed for COVID-19 should not be affected by recent mutations in the virus, according to a new study involving a University of York virologis...

Regeneron's REGN-COV2 antibody cocktail reduced vi…

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cockta...

Popular COVID-19 conspiracies linked to vaccine 'h…

A new study of beliefs and attitudes toward COVID-19 in five different countries - UK, US, Ireland, Mexico and Spain - has identified how much traction some prominent con...