UH Clinical Research Center COVID-19 Response

UH Research & Education Update | April 2020

The significance of being a distinguished academic medical center has never been more evident than in recent weeks when we have been able to combine our dedicated clinical research staff and extensive resources to successfully expedite study start-up activities to expand COVID-19 clinical trial opportunities and access to our patients.

Grace McComsey, MD: Vice President, Research & Associate Chief Scientific Officer

The UH Clinical Research Center (CRC) is continually pioneering new and innovative research processes.

• 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. Our staff was able to submit the study to the IRB in less than two days and secure full-board IRB approval a day later; a study start-up process which often takes 2-6 months nationally, took three full days (and nights) of work. Within the first 12-hours of study activation, the first UH patient enrolled, first of a total of 46 to date.
• The UH CRC also led efforts to expand clinical trial opportunities into our community sites by successfully on-boarding and opening the trials at nine of our satellite sites. This effort should lead to more system-wide study enrollment in other COVID and non-COVID studies.
• With excellent collaboration with our vigilent IRB led by Beth Hagesfeld,Manager, IRB, and the Research Support Core lead by Heather Tribout, Manager, Clinical Research, we quickly developed and implemented alternative consent processes for the COVID-19 participants and LARs to reduce the risk of exposure and infection for our patients, family, and staff.

The UH CRC is also leading COVID-19 research efforts by opening the “UH COVID-19 and Coronavirus Biorepository” under the leadership of Grace McComsey, MD, Principal Investigator. This protocol will allow investigators access to de-identified data and biological samples to help further COVID-19 research while ensuring the privacy of COVID+ patients. The CRC will provide more information and guidance through SOP and CRC email updates.

Our institution is involved in leading the ARMS-1 clinical research study. The ARMS-1 is expected to open very soon and will enroll approximately 4,300 participants across UH, MetroHealth, and Summa Health. This innovative research study aims to prevent spreading the COVID-19 infection to our caregivers through the administration of an investigational drug in the form of an oral spray. Previous studies have proven this oral spray to be effective in reducing viral infections from influenza and other seasonal viruses.

In addition to these COVID trials mentioned above, the CRC Cores and research staff are working to expedite other COVID studies, including several immune modulators, including Tocilizumab, Gimsilumab, CD24Fc, and Tofacitinib, and expanded access to Convalescent Plasma.

Several of our departments are also using their research staff to plan and implement other COVID studies, including convalescent plasma studies for patients with high troponin levels, stem cell therapies, hydroxychloroquine/azithromycin, and S-Nitrosylation.

University Hospitals has a proud history of leading the way through innovation and research. As we face the unknown with COVID-19, it is inspiring to see UH assembling a variety of novel and innovative ideas to learn more about how to prevent, treat, and cure COVID-19.