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April 29, 2020updated 12 Jul 2022 11:55am

Genentech’s arthritis drug tocilizumab shows promise in Covid-19 trial

Early data from a clinical trial in France has demonstrated encouraging profile of Roche unit Genentech's rheumatoid arthritis drug tocilizumab (Actemra) to treat seriously ill Covid-19 patients.

Early data from a clinical trial in France has demonstrated encouraging profile of Roche unit Genentech’s rheumatoid arthritis drug tocilizumab (Actemra) to treat seriously ill Covid-19 patients.

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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
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The study, which was conducted by the Paris university hospital trust (AP-HP), involved 129 hospitalised patients with moderate or severe viral pneumonia.

Tocilizumab is designed to mitigate the body’s natural immune response. It is thought to act by addressing cytokine storm, a hyper-immune response induced by the viral pneumonia.

During the trial, the drug was able to ‘significantly’ decrease the number of deaths or life support interventions when compared to a control group.

Around 50% of the trial participants received two tocilizumab injections and standard antibiotics therapy, while the control involved only standard treatment.

The study results, which are yet to be published, were said to indicate clear ‘clinical benefit’ with tocilizumab. However, additional research is required to validate the drug’s effectiveness and potential side effects.

Last month, Genentech received US Food and Drug Administration (FDA) approval to conduct a Phase III trial of the drug for the treatment of adults with severe Covid-19 pneumonia.

The Phase III trial, to be performed in partnership with the Biomedical Advanced Research and Development Authority (BARDA), will assess a combination of intravenous tocilizumab and standard of care in hospitalised patients.

In the US, Baylor College of Medicine has started assessing the drug in patients suffering from severe Covid-19 pneumonia.

Patients hospitalised at Baylor St. Luke’s Medical Center and Harris Health System ’s Ben Taub Hospital are being enrolled for the study, with an aim to recruit around 330 participants by the end of May.

The study will track clinical response to the drug, along with its safety and effectiveness. It will also monitor disease progression, duration of hospitalisation and need for critical care, among other supportive treatments.

In addition to Baylor College of Medicine , the trial is being performed at more than 50 sites across the US, Europe and Canada.

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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
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