- Two clinical trials testing potential treatments for the new coronavirus spreading from China are getting underway in Nebraska and Washington, marking a step forward in the U.S. efforts to find a therapy or vaccine for the pneumonia-like illness caused by the virus.
- In Nebraska, a placebo-controlled study run by a division of the National Institutes of Health has begun recruiting patients at the University of Nebraska Medical Center, where 14 Americans are being monitored and treated for coronavirus infections.
- The trial, which is designed to expand to include new centers and experimental drugs over time, will test first remdesivir, an antiviral originally developed by Gilead for use against the Ebola virus. Experts view the drug as among the more promising existing therapies for potential use against the new coronavirus, now called SARS-CoV-2.
Gilead's remdesivir was already high on the list of treatments researchers hope to show as effective against SARS-CoV-2.
While there's no human data that show's the drug's activity against this new coronavirus, previous animal testing by Gilead found the drug to be active against both the SARS and MERS viruses, which are genetically similar to SARS-CoV-2.
"There's only one drug right now that we think may have real efficacy. And that's remdesivir." said Bruce Aylward, a senior advisor and international leader of the World Health Organization's joint mission to China for COVID-19, at a Monday press conference.
Two studies of remdesivir are already underway in China, although Aylward noted that recruiting patients has proved difficult, due in part to the surge in studies of other potential treatments. The studies' enrollment criteria are another obstacle, as participants are not allowed to have received any other experimental drug for treating COVID-19 within the 30 days preceding screening.
Gilead expects results will be available from the two studies by April, a company spokesperson confirmed to BioPharma Dive.
The China trials will now will be joined by this recently launched study in Nebraska, which is set up to enroll nearly 400 patients.
Only 53 Americans have been diagnosed with coronavirus infections, per government numbers from Feb. 24, but U.S. officials are concerned the virus could quickly spread, as it has in South Korea, Italy and Iran.
The first participant in the NIH trial was an American who was repatriated from Japan after being quarantined on the Diamond Princess cruise ship, according to a Tuesday statement from the NIH.
The study is designed to be adaptive, a term used to indicate trials that can be modified over time. Researchers will test a series of 2-arm comparisons between an experimental drug and placebo. Should a treatment prove effective, that drug would then become the control arm in new comparisons.
As many as 50 sites globally are being contemplated, although the trial may not expand that widely.
An experimental vaccine developed by Moderna, meanwhile, will be evaluated in a NIH-led Phase 1 study at the Kaiser Permanente Washington Health Research Institute. According to trial details posted Tuesday, 45 healthy volunteers will be enrolled to receive one of three doses of Moderna's vaccine, and then followed through one year post second vaccination.
On Monday, Moderna shipped the first vials of its vaccine, which relies on messenger RNA, to the NIH, only one month after the biotech first announced plans to develop it. That's significantly faster than researchers have previously accomplished in response to viral outbreaks like SARS, although proving the vaccine's safety and efficacy in humans could potentially take several years.
In addition to Moderna and Gilead, a large group of biotechs, pharmaceutical companies and universities are attempting to develop therapeutics or vaccines against SARS-CoV-2. Almost all, however, lack the scale and manufacturing capacity to produce the large quantities which would be needed of any treatment that proves effective.
Johnson & Johnson and Sanofi are the only large pharmas actively developing vaccines, although GlaxoSmithKline is making some of its technology available to others.