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May 1, 2020

Covid-19 Healthcare Daily Update: Recruitment difficulties for Covid-19 drug treatment trials – Kevzara preliminary results announced

By Paul Dennis

1 May

Gilead’s suspension of remdesivir Covid-19 trials in China should serve as a bellwether for studies in other countries
As the Covid-19 outbreak becomes controlled, developers will increasingly face difficulties in recruiting infected patients for trials. In fact, as Gilead experienced in China, companies may have plans in place to initiate a trial, but when it comes time to begin enrolment, there may be insufficient numbers of patients to power the study.

Results from Sanofi’s Kevzara trial allows a more targeted approach for its final stages
On 27 April, Regeneron and Sanofi announced the preliminary results from the Phase II portion of an ongoing Phase II/III clinical trial evaluating Kevzara (sarilumab), an antibody targeting the interleukin-6 (IL-6) receptor, in hospitalised patients with severe or critical respiratory illness caused by Covid-19.

Fujifilm’s Phase II US trial of Avigan recruits ten out of 50 hospitalised Covid-19 patient target
Fujifilm Toyama Chemical’s US-based Phase II trial investigating Avigan (favipiravir) in hospitalised Covid-19 patients has recruited ten out of its 50-patient target, a source familiar with the trial said. The aim is to close enrolment this month, he added. While recruitment is expected to complete on time, the source noted a potential logistical challenge is the trial’s (NCT04358549) follow-up period: patients are required to do on-site visits to allow for nasal swabs, but those who drop out due to this trial design element would affect outcomes.

NIH/FDA working on standardised language for Covid-19 severity and trial templates
The National Institutes of Health (NIH) along with the US Food and Drug Administration (FDA) and medical bioresearchers are in the process of developing standardised Covid-19 severity terminology, as well as clinical trial templates to address, among other issues, biomarkers used in current clinical trials, like IL-6 and oxygen levels, said the FDA’s Center for Drug Evaluation and Research (CDER) Director, Janet Woodcock.

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