The Department takes on a major role in COVID-19 Clinical Trials

UMMC is starting eight clinical trials in the next days and weeks related to COVID-19. Currently two trials are active.

Dr. Gailen Marshall, (right) Division Chair of Allergy and Immunology and Executive Director of the Mississippi Clinical Research and Trials Center, is serving as principal investigator (PI) for two clinical trials involving critically ill COVID patients. The first trial, which is currently active, will study safety and efficacy of a monoclonal antibody directed against granulocyte-macrophage colony stimulating factor, a central component of the cytokine storm that is active in SARS-CoV2 infection.

The second involves treating COVID patients with antibodies contained in plasma from those who have recovered from COVID in order to neutralize the virus and perhaps modulate various immune mechanisms. Dr. Marshall feels these studies will help UMMC and other institutions prepare for a nearly inevitable return of coronavirus in future months and years by identifying when in the course of the COVID illness these treatments may be most effective and determine which patients may be most likely to respond to a specific intervention.

Dr. Jason Parham, (left) Infectious Diseases Division Director and Executive Vice Chair for the Department of Medicine, is serving as the PI for a study that opens access to remdesivir treatment for some of our affected patients; Drs. Navalkele, Lucar and Brock are also co-investigators. Its objectives are to provide expanded access to remdesivir for the treatment of SARS-CoV2 infection and to further evaluate the drug’s safety through evaluating incidence of treatment-emergent adverse events.

Dr. Parham, along with Dr. Navalkele (ID), and Drs. Spurzem, Wilhelm and Brewer (Pulmonary), are co-investigators on ORCHID (Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease) under Dr. Alan Jones who serves as PI at UMMC for this NIH-funded multi-center study. The study will enroll hospitalized patients or patients in the Emergency Department who are to be admitted to the hospital with known or suspected COVID-19 virus. Patients will be randomized to receive either hydroxychloroquine or placebo. The study will look to see if hydroxychloroquine improves outcomes for patients with COVID-19.

“Remdesivir and hydroxychloroquine are two of the most looked to treatment drugs for this patient population; we look forward to playing a small part in determining whether they are indeed safe and effective” says Dr. Parham.

Dr. Parham, who is part of the institutions’s COVID Command Center, states “we are doing our best to quickly adapt to shifting patient volumes, supply chain constraints, testing issues and new scientific knowledge, in order to ensure the safety of our providers so they may continue to fulfill UMMC’s mission of caring for all Mississippians through the duration of this pandemic.”

With UMMC’s clinical laboratory racing to bring in-house PCR testing online for SARS-CoV2, Infectious Diseases faculty have assisted in the effort by providing scores of samples from known positive patients. These samples have helped the lab validate multiple types of swabs, transport media, collection sites and platforms for testing. “Our clinical lab, under leadership from the Department of Pathology, has done a fantastic job of responding to the pandemic. Getting multiple options evaluated and ready for testing our patients has helped UMMC stay a step ahead of the supply chain issues that have made testing capacity and turnaround times so problematic across the state, country and world” says Parham.

Drs. Jason Parham (left), Jose Lucar (center), and Bhagy Navalkele (right) collecting samples while in personal protective equipment in the intensive care unit at UMMC.

More information about clinical trials related to COVID from UMMC News can be found here.

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