LONDON – As the epicenter of the COVID-19 epidemic shifted to Europe and the number of deaths in Italy exceeded the toll in China, the EU stepped up efforts to mount a coordinated response, with a big boost for collaborative R&D funding and a call for clinical research to be pooled in multicenter, multi-arm randomized controlled trials.
As COVID-19 testing remains elusive in the U.S., much of the nation’s focus has started to shift to how to treat the presumed millions of patients who are already or soon to be infected with the novel coronavirus.
DUBLIN – The Genentech arm of Basel, Switzerland-based Roche Holding AG plans to move its interleukin-6 (IL-6) inhibitor, Actemra (tocilizumab), into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.
PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
The first attempt at using existing drugs to treat patients infected with SARS-CoV-2 has yielded disappointing results. In 200 hospitalized patients with severe COVID-19, a 14-day regimen of twice-daily treatment with Kaletra/Aluvia (lopinavir/ritonavir, Abbvie Inc.) did not hasten recovery when added to the standard of care.
The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April.
LONDON – In the rush to test drugs against COVID-19, clinical trials in other indications are starting to be interrupted by the strains on health care systems and the fact that many potential patients are those most at risk from the effects of the novel coronavirus.
With medical researchers across the globe adjusting to the far-reaching impacts of COVID-19, commercial and academic trialists are taking action to protect essential studies. Regulators, too, are now joining the effort in a more concerted way, with the FDA issuing new guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic.
As the world goes to war with COVID-19, the U.S. is ripping open the purse strings to fund mobilization against both the coronavirus and the economic devastation it’s causing.
Randomized trials of the broad-spectrum antiviral favipiravir, marketed as an anti-influenza treatment by Fujifilm Holdings Corp., have shown "obvious efficacy" against COVID-19, according to Zhang Xinmin, head of the China National Center for Biotechnology Development.
