Researchers at the University of Rochester Medical Center expected to enroll their first patient Thursday in a clinical trial for a potential COVID-19 treatment.
Testing of a possible vaccine could begin as early as June.
Both offer hope — but not immediate relief —at a time when the intensifying outbreak has seen rising and increasingly acute hospitalizations, with numbers more than doublingsince Monday.
"Itis very difficult, because we are trying to make treatment decisions essentially with no information," said Dr. Ann Falsey, who practices at Rochester General, is on the URMC faculty and is co-leading the clinical trial locally with Dr. Angela Branche of the URMC Vaccine Trials and Evaluation Unit..
"We've only been at this two weeks," Falsey said. "It seems like another lifetime ago, (but) we have not had active cases very long. ... We are just learning the full spectrum of the disease."
And Rochester figures to play a pivotal role.
Years ago, the National Institutes of Health set up a pandemic response pipeline, establishing five "centers for excellence" in influenza research. The New York center isled by David Topham at URMC, and has investigators not just in Rochester but also across the nation and as far away as Melbourne, Australia.
Rochester, Tophamsaid, is specifically geared toward human immune response with a depth of experience in bacterial and viral respiratory pathogens.
"We have quite a bit of activity ongoing surrounding this virus," Topham said."It’s a bigshifting of gears to adapt to this new pathogen. ... (But) itis going to take weeks to months before we have answers to these questions.
"Believe me, we are moving as fast as we possibly can."
'So much to learn'
The NIH-sponsored clinical trial involves the antiviral drugremdesivir.Testing is ramping up at 37 sites across the United States, in Japan, South Korea and Singapore. The double-blind, placebo-controlled trial will involve adult patients at Strong Memorial Hospital who will undergo intravenous treatment over a 10-day period.
Strong is one of three test sites in New York, and the only one upstate .
This is not the malaria drug or drug combination touted by President Trump and others.
Rather, remdesivir was developed as potential treatment for the Ebola virus and reportedly has shown promise in animals for treatingMiddle East respiratory syndrome and severe acute respiratory syndrome, both of which are caused by other coronaviruses.The drug is thought to block an enzyme required for the virus to replicate.
The NIH is moving quickly, with the goal of enrolling 400 people over a 30- to 50-day period. Patients will be evaluated on Day 15. If their condition improves and they are discharged, Falsey said, researchers will continue to track them for a month.
Investigators are hoping for an early read on effectiveness, she said, but the study is designed to be expanded over time to include additional treatments.
The vaccine trial, when launched, would involve young, healthy people and work much like a flu vaccine, injecting a key protein or part of the virus, stimulating the person's immune system to produce antibodies.
Topham's team, meanwhile, is shifting an existing influenza study to focus instead on the novel coronavirus. That work— which aims to enroll 100 outpatientsover 180 days — will require regular blood samples as well as nasal samples from the time of their first positive test, looking at immune responses and virus mutations.
Another study through the New York Influenza Center of Excellence will use existing stores of blood and serum to assess whether people of different age groups have pre-existing immunity to the virus.
"People do not have neutralizing antibodies or immunity that would prevent you from being infected," Topham said. "But they likely have T-cell immunity," which can determine whether the infection is mild or severe.
When the H1N1 virus emerged in 2009,the assumption was that the elderly would be at risk. They were not. Because, while the virus was unlike any virus of the previous 10 to 20 years, which left the younger population vulnerable, those who were older had been exposed to similar viruses early on in life.
While reports coming out New York City hospitals are raising alarms, Falsey said the pace locally has been manageable. People are stressed, and there is tension, because it is a new disease with so much unknown. Doctors are finding patients presenting with a variety of symptoms, she said, not just cough and fever. There are gastrointestinal effects, or weakness and falling.
"It's a learning process. I can't say it's evolving," Falsey said."We have have so much to learn."
Contact reporter Brian Sharp at bdsharp@gannett.comor at 585-258-2275. Follow him onTwitter @sharproc.This coverage is only possible with support from our readers. Sign up today for a digital subscription.
