By Jackie Kruszewski

As COVID-19 cases in the U.S. surge, Virginia Commonwealth University researchers continue to look for safe and effective treatments for those affected by the virus.

A new clinical trial called ACTIV-1 will enroll VCU Health volunteers to test three “immune modulator” drugs on people hospitalized with COVID-19. The drugs target the dangerous inflammation doctors have seen in COVID-19 patients called the “cytokine storm” — a situation in which the body begins to attack its own cells and tissues, rather than the virus.

“The hope is that these drugs might restore balance to the immune system,” said trial lead Arun Sanyal, M.D., a professor in the Department of Internal Medicine in the VCU School of Medicine. “The cytokine storm can lead to respiratory distress, organ failure and other life-threatening complications, so a drug that counteracts these symptoms could reduce fatalities, shorten hospital stays and lessen the need for ventilators.”

All participants in the trial will receive remdesivir, which was the first FDA approved treatment for COVID-19. Sanyal brought the remdesivir trial to VCU in March, leveraging the university’s research infrastructure to bring early, experimental treatment to VCU patients and contributing to national data collection.

The new trial will test whether adding another medication — one of three study drugs — to remdesivir is safe and effective for the treatment of COVID-19. The three drugs being studied are infliximab, abatacept and cenicriviroc. One in four randomized participants will receive a placebo, rather than one of the three active study drugs.

Two of the drugs, infliximab and abatacept, have been approved by the FDA to treat other inflammatory medical conditions such as arthritis, bowel diseases and severe skin conditions. The study team will compare the effects of remdesivir with and without one of the three study drugs.

“Nine months ago, we knew next to nothing about COVID-19,” said Sanyal, the education core director at VCU’s C. Kenneth and Dianne Wright Center for Clinical and Translational Research. “But we’re learning a little more every day. Joining this trial is the result of tireless work and careful study here at VCU of the emerging data.”

The National Institutes of Health (NIH) launched the trial in October, part of a federal initiative to accelerate COVID-19 treatments and vaccines. The NIH’s National Center for Advancing Translational Sciences will coordinate and oversee the trial, which expects to enroll approximately 2,000 hospitalized adults with moderate-to-severe COVID-19 in the United States and Latin America — with a focus on those from communities disproportionately affected by COVID-19.

“Our physicians and researchers, in partnership with colleagues at the NIH and across the country, are building on an extraordinary foundation of knowledge and research capacity in order to combat COVID-19,” said Arthur Kellermann, M.D., senior vice president for health sciences at VCU and CEO of VCU Health System. “Trials like this one will pave the way for scientifically meaningful data that improves care for patients at VCU Health and beyond.”  

VCU quickly and safely initiated multiple COVID-19 clinical trials this summer, some ongoing and some now complete. These include:

• New clinical trial seeks to prevent transmission of COVID-19 between household members
• VCU Health one of world’s first sites to test canakinumab against COVID-19
• Clinical trials underway on arthritis drug to treat COVID-19-related pneumonia

The VCU COVID-19 Clinical Trials Oversight Committee, led by Wright Center Director F. Gerard Moeller, continues to evaluate and prioritize trials and studies that will help the medical community learn more about the coronavirus.

To learn more about our COVID-19 research, please visit our COVID-19 news site.