Wayne State University Investigators Gets Very Busy in War Against COVID-19 with Multiple Regional Studies

Apr 25, 2020 | Anti-Infective Research Laboratory, Coronavirus, COVID-19, Detroit, Hydroxychloroquine, Leading Sites, Michigan, Site Success, Site Watch, Wayne State University

Wayne State University Investigators Gets Very Busy in War Against COVID-19 with Multiple Regional Studies

Wayne State University attacks the COVID-19 pandemic on a couple of different fronts. The Detroit, Michigan-based university’s pharmacy and health sciences faculty, students, and alumni mobilize in head-to-head battle against SARS-CoV-2 (the virus behind the COVID-19 pandemic) on the front-lines in hospitals, clinics, and health centers in the Detroit area while researchers in the labs and clinics work relentlessly to find effective and safe weapons that can support the fight and help patients struggling with COVID-19.

When it comes to clinical trials targeting COVID-19, Michael Rybak helps lead the charge for Wayne State. A Professor of Pharmacy, Professor Rybak, is working long hours in the lab these days—and nights. He is a member of the Society of Infectious Disease Pharmacists and he has participated in the development of national guidelines on MRSA and other infectious diseases. Rybak takes on COVID-19 on two fronts, including 1) representing Wayne State University (along with others) and four metro-Detroit hospital systems to bring large-scale COVID-19 clinical trials to Southeast Michigan, and 2) spearheads the Anti-Infective Research Laboratory (ARL) ready to commence two key clinical trials, pending the necessary Institutional Review Board (IRB) approval. TrialSite News reviews these two programs.

Southeast Michigan Clinical Research Efforts

Wayne State University has teamed with local hospital systems to determine what dose of hydroxychloroquine is most efficacious and safe in the context of SARS-CoV-2 infections. This important Detroit metropolitan area-based initiative involves physicians/investigators from the Henry Ford health System, Ascension Michigan, Beaumont, Detroit Medical Center, and of course Professor Rybak’s Wayne State University. The prominent collaborators have joined forces to form this important study group. The combination of these five providers collectively treat millions of patients each year. Hence the opportunity for a large-scale study exploring potentially life-saving treatment options.

Their first study deals with the controversial hydroxychloroquine—at what dose is this anti-malarial drug most safe and efficacious concerning the treatment of patients with COVID-19. Professor Rabak commented for Wayne State University School of Medicine News that “While hydroxychloroquine is currently being used to treat patients with COVID-19, the exact amount to use and for how long is not known.” The pharmacy professor continued, “We are basing all of our current treatment on how it is used in treating malaria, rheumatoid arthritis or lupus.” Hence these fine Michigan-based providers now seek how to explore the answer.

Anti-Infective Research Laboratory (ARL)

The ARL is preparing to commence two key studies once IRB approval is in hand. 

A PK/PD study of Hydroxychloroquine

In the first study, the ARL will conduct a dose-response PK/PD study (pharmacokinetic is what the body does to a drug, pharmacodynamic is what a drug does to the body) by drawing blood levels of hydroxychloroquine on patients who are being treated for COVID-19.

This important study will be conducted at the Detroit Medical Center and Henry Ford Hospital in conjunction with the division of infectious diseases at both provider institutions. Getting involved with the research, the Mayo Clinic will analyze hydroxychloroquine blood levels for the study while Wayne State University mobilizes a team of investigators skilled at PK/PD modeling to analyze the data—including the modeling of various scenarios in a quest to optimize the dose of hydroxychloroquine.

A Major Retrospective Evaluation of COVID-19 therapy

In the second study, ARL will participate in a multicenter, multistate retrospective evaluation of COVID-19 therapy, with at least 10 academic center participants. Pharmacy professor Rybak reports that this second larger multicenter study “will allow us to understand how COVID-19 is being treated across the country.” Rybak, as a member of the Society of Infectious Diseases Pharmacists, has a keen interest in understanding how they should update national treatment guidelines.

Gratitude

Professor Rybak steps back and considers, despite the absolutely devastating situation faced across America—and the world—that there is a need for gratitude as well. The way that people have come together across a multi-faceted array of healthcare disciplines has been formidable: Rybak declares “I am grateful to my research fellows, assistants and collaborating colleagues who have come together so quickly to work on these two important studies to make a difference. There are so many clinician/researchers who are working together to find the best appropriate therapy for COVID-19 patients.” And because of the severity of the impact; the magnitude of this problem Rybak stated “This is a challenging but inspiring time for clinicians and researchers to assist with this crisis.”

About Wayne State University

Wayne State University (WSU) (the “Warriors”) is a public research university in Detroit, Michigan. Representing the State of Michigan’s third-largest university, it was founded in 1868 and today consists of 13 schools and colleges offering more than 350 programs to nearly 27,000 graduate and undergraduate students. WSU, along with the University of Michigan and Michigan State University, comprise the University Research Corridor of MichiganThe School of Medicine was founded in 1868. With programs in 14 areas of basic science and public health to nearly 400 students annually, they cover a broad range of research topics.

The medical school’s legacy spans back to the Civil War when five physicians who witnessed the crude medical treatment on the battlefields committed themselves to advancing health education and care in Detroit—this very first organization was called the Detroit Medical College, which has since transformed into the School of Medicine. Now an internationally renowned school that has contributed to landmark medical achievements such as the world’s first successful open-heart surgery and the discovery of AZT for the treatment of AIDS.

Lead Research/Investigator Profiled

Professor Michael Rybak, PharmD, MPH, PhD

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