The National Institutes of Health (NIH) in the US has suspended a clinical trial being performed to assess the safety and effectiveness of hydroxychloroquine to treat adults with Covid-19.

This decision comes after a data and safety monitoring board (DSMB) found that the drug is not likely to be beneficial in this indication compared to placebo. NIH noted that the data indicated no harm with the drug.

After a fourth interim analysis, the DSMB recommended the National Heart, Lung, and Blood Institute (NHLBI) to halt the study.

The blinded, placebo-controlled randomised trial was designed to enrol more than 500 Covid-19 patients, with around 470 recruited at the time of the trial’s closure.

Participants were given hydroxychloroquine 400mg twice daily for two doses, followed by 200mg twice daily for the next eight doses, or a placebo twice daily for five days.

NIH said in a statement: “The data from this study indicate that this drug provided no additional benefit compared to placebo control for the treatment of Covid-19 in hospitalised patients.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Meanwhile, Swiss pharmaceutical company Novartis has also decided to suspend its hydroxychloroquine trial for Covid-19 over enrolment challenges, which made completion of the trial infeasible.

The company also noted that no safety issues have been reported and no conclusions have been made on efficacy from its trial.

A statement from Novartis read: “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.”

The company will continue to supply the drug for certain ongoing investigator-initiated trials (IITs) and upon government requests.

Earlier this month, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) suspended enrolment of participants for all Covid-19 clinical trials of hydroxychloroquine across the country.