New clinical trial to test possible therapeutics for COVID-19 in hospitalized patients

The Clinical Trials Network of Tennessee (CTN2) at the University of Tennessee Health Science Center has contracted a new clinical trial to test possible therapeutics for COVID-19 in hospitalized patients. This new trial brings the total generated by CTN2 contracts for the university to nearly $7 million.

Since its launch in 2018, CTN2 has brought more than 200 clinical trial opportunities to the university and the citizens of Tennessee. Steven R. Goodman, PhD, vice chancellor for Research at UTHSC, who led the creation of CTN2, lauded "the tremendous success" of the nonprofit that enables clinical research faculty across all the UTHSC campuses, who are affiliated with hospitals, to effectively respond to opportunities for clinical trials with pharmaceutical, biotech, and medical device industry partners.

CTN2 was created to increase the number of important clinical trials that can be conducted by our faculty, while providing credit to UTHSC for these trials and improving its national ranking as a Research Academic Health Center. The growth of CTN2 into a statewide network of 13 hospital and practice plan partners over a two-year period has been remarkable. Most importantly, these CTN2-contracted clinical trials will improve the health care of the citizens of Tennessee."

Steven R. Goodman, PhD, Vice Chancellor, Research, University of Tennessee Health Science Center

This new trial, the third for CTN2 that involves COVID-19-related research, will evaluate the effectiveness and safety of already available drugs to treat immune system inflammation in COVID-19 patients. Immune system inflammation associated with COVID-19 has emerged as a key factor affecting the survival rate of at-risk groups.

"People with severe COVID-19 experience an inadequate immune response," said Ivan Romero-Legro, MD, assistant professor of Pulmonary, Critical Care and Sleep Medicine at UTHSC and principal investigator of the trial. "Inflammation, the body's reaction to an infection, is the body's normal response to infection.

If not controlled, it will lead to damaging effects on the body. We believe controlling inflammation can decrease the severity of the disease and mortality. The medications we'll be testing have been approved for psoriatic arthritis, plaque psoriasis, rheumatoid arthritis, atopic dermatitis, and ulcerative colitis due to anti-inflammatory properties. The importance of this trial is to find a new medication to fight COVID-19 and decrease the severity of the disease in our community."

Phil Cestaro, associate vice chancellor for Research and Business Development in the Office of Research at UTHSC, pointed out that conducting clinical trials for COVID-19 highlights the need for innovative collaborations in the health care marketplace to fight the pandemic.

"Instead of individual companies running separate trials simultaneously, COVID protocols have combined various drugs under a single study. This allows for the comparison of drugs from multiple companies with the ability to include additional drugs as necessary," Cestaro said.

Julio Lanfranco Molina, MD, associate professor of Pulmonary, Critical Care and Sleep Medicine at UTHSC, is the sub-investigator on the double-blind trial, which will be conducted at Regional One Health with patients who have been evaluated in the hospital and determined to be good candidates.