University Hospitals Leads the Way in COVID-19 Clinical Trials

Scientific discovery critical to emerging from the pandemic

UH Innovations COVID-19 Special Issue | Summer 2020

Over the past several months of the COVID-19 pandemic, University Hospitals has quickly mobilized and positioned itself to secure and execute some of the first COVID-19 clinical trials in the world.

Grace McComsey, MD

“Our institution was one of the first in the U.S. to successfully expedite study start-up activities for two Phase 3 COVID-19 remdesivir trials, submitting the study to the our Institutional Review Board in less than two days and securing full board approval one day later,” says Grace McComsey, MD, FIDSA, Vice President of Research and Associate Chief Scientific Officer of University Hospitals Director of the Clinical Research Center, Division Chief, Pediatric Infectious Diseases, UH Rainbow Babies & Children's Hospital; and Professor of Pediatrics, Case Western Reserve University School of Medicine.

For comparison, a study start-up process takes two to six months nationally. Within the first 12 hours of study activation, the first UH patient was enrolled, and 100 participants enrolled in the next few weeks.

The UH Clinical Research Center is also championing COVID-19 research efforts by opening the UH COVID-19 Centralized Biorepository, under Dr. McComsey’s leadership. This protocol will allow investigators access to a variety of biological samples and de-identified data to help further COVID-19 research while ensuring privacy of COVID-positive patients.

Beyond these projects, UH’s Robert Salata, MD, Chairman of the Department of Medicine at UH Cleveland Medical Center, Program Director of the UH Roe Green Center for Travel Medicine & Global Health and Professor of Medicine, Epidemiology and International Health at the School of Medicine, is leading the ARMS-1 clinical research study that will enroll approximately 4,300 participants across UH and two other regional health systems. The trial is designed to assess whether the investigational oral spray ARMS-1 helps prevent airborne transmission of coronavirus and whether it reduces the symptoms of healthcare providers who have tested positive for the virus.

“Our healthcare workers risk exposure to the coronavirus every day and it’s important to find strategies that might help them, beyond providing personal protective equipment,” says Dr. Salata. “A previous study suggested this drug might be effective as a throat spray in reducing infection. The goal of this trial is to rapidly determine whether ARMS-I is effective in providing protection against COVID-19 for frontline health workers. We will be measuring whether there is a decrease in the rate of COVID-19 infection, and also whether there is a decrease in the frequency, duration, and severity of acute upper respiratory infection in caregivers who may contract the virus.”

UH Cleveland Medical Center is also the first clinical site for the MACOVIA (MultiStem Administration for COVID-19 Induced Acute Respiratory Distress Syndrome) trial. – an important randomized, double-blind, placebo-controlled study. Frank Jacono, MD, a Pulmonary and Critical Care Medicine specialist at UH Cleveland Medical Center and Associate Professor of Medicine Case Western Reserve University School of Medicine, is serving as principal investigator. Acute respiratory distress syndrome (ARDS) is the leading cause of death among COVID-19 patients, The MACOVIA trial aims to confirm the safety and efficacy of MultiStem therapy as a treatment for patients with moderate to severe ARDS due to COVID-19.

Other investigators at UH are conducting COVID-19 trials with immune modulators, including tocilizumab, tofacitinib, a new fusion molecule CD24Fc, and two studies of convalescent plasma. Some other specific projects of note:

• Arash Rashidi, MD, Director of the Nephro-Oncology program, is leading STOP-COVID: Study of the Treatment and Outcomes in Critically-Ill Patients with COVID-19. This multi-center observational study will look at the clinical features and outcomes of critically ill patients with COVID-19 who are admitted to intensive care units across the U.S. Dr. Rashidi and his team would like to determine independent risk factors for hospital mortality and acute organ injury and identify treatment strategies associated with improved survival.
• Colin McCloskey, MD, Emergency Medicine specialist, is serving as principal investigator for the ECMOCard study -- ExtraCorporeal Membrane Oxygenation for 2019 Novel Coronavirus Acute Respiratory Disease. The goal of this study is to describe clinical features, including the severity of pulmonary dysfunction, ECMO technical characteristics, duration of ECMO complications, and survival of patients with COVID-19. “Given the volume of COVID patients requiring ICU care, there is a large data acquisition burden,” Dr. McCloskey says. “Nicely, the EMR has all necessary data elements, so most of the work can be performed remotely from patient care areas.” Dr. McCloskey’s study includes more than 230 centers internationally.
• Olivia Giddings, MD, PhD, from Pediatric Pulmonology at UH Rainbow Babies & Children’s Hospital, is principal investigator on two studies using different drugs to modulate the inflammatory response in patients with COVID-19, one with CD24Fc and the second with gimsilumab in subjects with lung injury or Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19. “The immune response seems to be over-reactive in some patients with COVID-19 and can lead to severe lung disease such as ARDS as well as kidney failure and damage to other organs,” Dr. Giddings says.
• Afshin Dowlati, MD, Lucile and Robert H Gries Endowed Director of the Center for Cancer Drug Development and Director of the Thoracic Oncology Program at UH Seidman Cancer Center, is expanding an existing clinical trial with the experimental agent TAK-981 to patients with advanced cancer who are also positive for COVID-19. The current Phase I findings with this agent have shown substantial pharmacodynamics effects on the anti-viral response mechanism. Furthermore, pre-clinical evidence demonstrates anti-viral activity. UH is one of just six sites in the world with access to TAK-981.

With these and other COVID-19 research projects – some 75 in all – Dr. McComsey says she’s impressed with how UH researchers have matched the moment.

“I have immense gratitude for PIs and study teams who selflessly lead and support our clinical research and trials,” Dr. McComsey says. “The empathy they have for their patients and incomparable desire to contribute to better health outcomes is unmatched as it exemplifies UH’s mission: To Heal. To Teach. To Discover.”

To speak with Dr. Grace McComsey or be connected with one of our UH researchers, call 216-930-5603.