An urgent search for solutions: Michael Rybak leading COVID-19 clinical trials

Dr. Michael RybakWhile scores of Wayne State pharmacy and health sciences faculty, students and alumni are engaged in head-to-head battle with COVID-19 on the front lines, college researchers are relentlessly searching for effective and safe weapons that can be used in that fight.

Professor of Pharmacy Practice Michael Rybak is among those keeping late hours in the lab. In addition to being part of the collaborative effort between Wayne State University and four metro Detroit hospital systems to bring large-scale COVID-19 drug trials to Southeast Michigan that was announced on March 27, Rybak's Anti-Infective Research Laboratory (ARL) is poised to begin two key studies, pending Institutional Review Board approval.

The first is a study to determine what dose of hydroxychloroquine is most efficacious and safe. "While hydroxychloroquine is currently being used to treat patients with COVID-19, the exact amount to use and for how long is not known," said Rybak. "We are basing all of our current treatment on how it is used in treating malaria, rheumatoid arthritis or lupus."

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. The study will be conducted at the Detroit Medical Center and Henry Ford Hospital in conjunction with the division of infectious diseases at both institutions. The Mayo Clinic will be running the hydroxychloroquine blood levels for the study and WSU will analyze the data with a group of investigators who are skilled at PK/PD modeling to optimize the dose of hydroxychloroquine.

"For the first time, we will be able to determine the most appropriate dose that will improve efficacy and reduce unwarranted side effects," Rybak said.

The second study is a multicenter, multistate retrospective evaluation of COVID-19 therapy, with at least 10 academic center participants. "This will allow us to understand how COVID-19 is being treated across the country," said Rybak, who is one of the founding members of the Society of Infectious Diseases Pharmacists and has helped develop national guidelines on MRSA and other infectious diseases.

"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," said Rybak. "This is a challenging but inspiring time for clinicians and researchers to assist with this crisis."

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