View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
July 6, 2020updated 12 Jul 2022 11:44am

WHO stops hydroxychloroquine and lopinavir/ritonavir trial arms

The World Health Organization (WHO) has decided to discontinue hydroxychloroquine and lopinavir/ritonavir arms in its Solidarity Trial, which is being conducted to assess potential treatments for hospitalised Covid-19 patients.

The World Health Organization (WHO) has decided to discontinue hydroxychloroquine and lopinavir/ritonavir arms in its Solidarity Trial, which is being conducted to assess potential treatments for hospitalised Covid-19 patients.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

The decision is based on the trial’s International Steering Committee recommendation that comes after review of interim data from these treatment arms.

According to the committee, the data revealed that hydroxychloroquine and lopinavir/ritonavir demonstrated little or no decreased in the mortality of hospitalised patients with Covid-19, compared to standard of care.

WHO said in a statement: “The International Steering Committee formulated the recommendation in light of the evidence for hydroxychloroquine vs standard-of-care and for lopinavir/ritonavir vs standard-of-care from the Solidarity trial interim results, and from a review of the evidence from all trials presented at the 1-2 July WHO Summit on Covid-19 research and innovation.”

WHO noted that the trial investigators will discontinue the arms with immediate effect.

The organisation added that the interim data showed no ‘solid evidence’ that these drugs increased mortality. However, certain related safety signals were observed in the clinical laboratory findings of the add-on Discovery trial, a participant in Solidarity.

This decision to discontinue the arms is applicable only to the the Solidarity trial in hospitalised patients and not the potential assessment in other studies of these drugs in non-hospitalised patients or as pre- or post-exposure prophylaxis for Covid-19.

Last month, the National Institutes of Health (NIH) in the US and pharmaceutical company Novartis also suspended their respective trials of hydroxychloroquine in Covid-19 patients.

In addition, data from a RECOVERY clinical trial being conducted in the UK showed no benefit with lopinavir/ritonavir in patients hospitalised with Covid-19.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena