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May 7, 2020updated 12 Jul 2022 11:48am

Keck Medicine to launch clinical trial for coronavirus treatment

Physicians from Keck Medicine of USC are set to launch a clinical trial to study the effects of an anti-inflammatory drug on treating patients with moderate to severe coronavirus (Covid-19).

Physicians from Keck Medicine of USC are set to launch a clinical trial to study the effects of an anti-inflammatory drug on treating patients with moderate to severe coronavirus (Covid-19).

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The medication baricitinib has been approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis.

Baricitinib is an oral JAK1/JAK2 inhibitor with approvals in more than 65 countries to treat adults with moderately to severely active rheumatoid arthritis.

The drug’s anti-inflammatory activity is expected to act on the inflammatory cascade associated with Covid-19.

Keck Medicine infectious disease specialist Michael Dube said: “We are learning that in some Covid-19 cases, inflammation might be driving the need for intubation and causing poor outcomes.”

Baricitinib has been shown to lower levels of a cytokine known as interleukin-6, which is a dangerous complication that can stem from Covid-19.

The drug is also said to lower levels of other cytokines.

The clinical trial is designed as a double-blind, randomised controlled study where half the participants will receive a baricitinib tablet as a daily regimen and the other half will receive a placebo.

A total of 144 patients from Keck Hospital of USC, USC Verdugo Hills Hospital and Los Angeles County + USC Medical Center are expected to be enrolled for the research.

Dube added: “Our premise is that by using baricitinib to reduce the inflammation, we may be able to slow down the progress of the disease, stop the need for a ventilator, and save lives.”

Last month, Eli Lilly announced plans to conduct a clinical trial of baricitinib (Olumiant) for the treatment of patients with Covid-19.

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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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