Since COVID-19 hit Rochester in March of 2020, a team of University of Rochester Medical Center clinicians and researchers has mobilized to bring the most promising clinical trials - that address the broadest swath of patients’ needs - to the Medical Center. URMC has joined three clinical trials that provide extra treatment options for some of the sickest COVID-19 patients.
When the first COVID-19 cases hit the University of Rochester Medical Center’s ICU back in March of 2020, there were no proven treatments available, but experimental therapies were cropping up around the world. Quickly, a team of URMC clinicians and researchers mobilized to bring the most promising clinical trials - that address the broadest swath of patients’ needs - to URMC. Since then, URMC has joined three clinical trials that provide extra treatment options for some of the sickest COVID-19 patients.
COVID-19 causes a wide range of outcomes: some infected people never show a single symptom, while many battle the disease for weeks in the ICU. The difference between those outcomes seems to lie in a careful balance of the immune response. In the beginning of the disease, the immune system helps fight off the virus. But for those who land in the hospital, this early, helpful immune response gives way to uncontrolled over-activation of the immune system, causing system-wide inflammation and severe complications.
The three COVID-19 inpatient clinical trials currently running at URMC attack the disease at both ends of this balance.
“Our goal has always been to promote effective therapies through clinical trials,” said Martin Zand, M.D., Ph.D., senior associate dean for Clinical Research and co-director of the Clinical & Translational Science Institute. “Our team is working hard to make sure that the trials we bring to URMC have the greatest chance of benefiting our own patients, and significantly advancing the science of COVID-19 to benefit patients around the world.”
Remdesivir: Adding a One, Two Punch
In March, URMC joined a national clinical trial, which recently showed that the antiviral drug remdesivir sped recovery for COVID-19 patients – especially those with moderate disease. The National Institutes of Allergy and Infectious Diseases, which led that trial, is now testing remdesivir alongside baricitinib, an anti-inflammatory drug that is approved by the FDA to treat rheumatoid arthritis.
While remdesivir acts early in COVID-19 progression by preventing the SARS-CoV-2 virus from multiplying, baricitinib acts late in the disease by tamping down the over-activation of the immune system. Together, the hope is that remdesivir and baricitinib provide a one, two punch that can knock COVID-19 out cold.
The new study, which was run through the Medical Center’s Vaccine and Treatment Evaluation Unit (one of only nine such sites in the US), closed last week. Trial results are being analyzed and are not expected to be released for several weeks, according to local study leads, Ann Falsey, M.D., and Angela Branche, M.D., A third phase of the study is in planning stages.
Quieting Inflammation at All Ages
While researchers have high hopes that baricitinib can quell the over-exuberant immune activity of COVID-19, that trial is only open to patients who are 18 years old and up. Another trial, sponsored by Incyte Corp, is testing a very similar drug, called ruxolitinib, in patients as young as 12 who have very severe COVID-19 disease and need to be on a ventilator.
When the immune system runs amok in the late stages of COVID-19, the lining of the lungs can become leaky, allowing fluid to build up in the lungs’ air sacs. This phenomenon, called acute respiratory distress syndrome, starves the body of oxygen and mechanical ventilation can even fail to rescue these patients.
The URMC team, led by Christopher Palma, M.D. and Steve Georas, M.D., expects to enroll up to 20 severely ill COVID-19 patients in the trial to see if ruxolitinib can keep them alive and get them off ventilators and out of the ICU sooner.
A More Tailored Attack
Most recently, URMC joined a clinical trial sponsored by Regeneron Pharmaceuticals to test whether a pair of monoclonal antibodies, collectively referred to as REGN-CoV2, can reduce viral shedding and speed recovery of hospitalized COVID-19 patients. The antibodies, developed in mice with genetically humanized immune systems, bind to the Spike protein on the surface of SARS-CoV-2 and block it from infecting cells.
This trial, also led locally by Palma and Ummara Shah, M.D., will enroll 20 COVID-19 patients hospitalized at URMC with moderate to severe disease.
Learn more about coronavirus research at URMC and register to participate in future COVID-19 or other clinical studies.