MidMichigan Health Centers in Midland and Gratiot are the only two Michigan hospitals to date to participate in a global clinical study designed to test the ability of various drugs to improve the health outcomes of people with COVID-19. The ACTIV-1 study is testing promising immune modulator compounds, a class of drugs that help minimize the negative effects of an overactive immune response to the virus.
The Phase 3 clinical trial will evaluate the safety and efficacy of three different drugs that inhibit different parts of the immune system: infliximab (REMICADE®), developed by Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson; abatacept, (Orencia®), developed by Bristol Myers Squibb; and cenicriviroc, an investigational drug developed by AbbVie.
“Patients who meet criteria and consent to this clinical study are randomly assigned like roll of the dice, to one of three immune modulators or placebo,” said John Blamoun, M. D., F.C.C.P., local principal investigator and director of critical care medicine at MidMichigan Medical Center – Midland. “There is a three in four chance that patients receive one of the three active immune modulator medications. All patients are followed for 60 days to report recovery, as well as additional health outcomes.”
To participate in the study, patients must have moderate to severe COVID-19 symptoms and be admitted to the hospital for treatment. “Our clinical research nurses screen patients for full eligibility and coordinate with the treating provider and Dr. Blamoun and myself for enrollment,” said Brittany Harrington, D.O., local co-investigator and hospitalist at MidMichigan Medical Center – Gratiot. “To date, we have enrolled 11 patients between our two hospitals.”
At least 60 sites in the U.S. and 30 sites in Latin America, are expected to participate to help enroll the 2,160 patients needed for the study.
According to the National Institutes of Health (NIH), the ACTIV public-private partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates.
“The ACTIV-1 study will help determine if these immune modulators will tame the immune response, shorten hospital days and reduce the need for a ventilator,” added Dr. Blamoun.
Those who would like additional information on the ACTIV-1 study may visit www.activ-1.org. Additional information about clinical trials can be found at www.midmichigan.org/clinicaltrials.