MADISON, Wis. – The University of Wisconsin School of Medicine and Public Health and UW Health will conduct three clinical trials to test a new treatment and preventative for COVID-19, in collaboration with Regeneron Pharmaceuticals.
The school will use its companion health system UW Health as a trial site to evaluate an “antibody cocktail,” dubbed REGN-COV2, created by the Tarrytown, New York-based pharmaceutical company.
To create REGN-COV2, the company’s scientists selected virus-neutralizing antibodies produced from mice that have been genetically modified to simulate a human immune system, as well as antibodies identified from humans who have recovered from COVID-19, according to Regeneron.
The experimental antibodies interact with the receptor binding domain of the COVID-19 virus’s spike protein and block viral interaction with human angiotensin-converting enzyme 2, or ACE2, which is the protein the virus docks with during infection.
The three trials include:
- An adaptive Phase 1, 2 and 3 randomized, double-blinded, placebo-controlled study to evaluate the safety and efficacy in hospitalized patients with COVID-19.
- An adaptive Phase 1, 2 and 3 randomized, double-blinded, placebo-controlled study to evaluate the safety and efficacy in non-hospitalized patients with COVID-19.
- A Phase 3 randomized, double-blinded, placebo-controlled study to evaluate the ability of REGN-COV2 to prevent an infection of the virus that causes COVID-19 in people who have been exposed to someone in their household with the disease.
UW Health is one of approximately 100 sites in the United States. Recruitment will begin immediately with a goal of enrolling 30 to 50 people per trial at the site. The trials will be led by Dr. William Hartman, assistant professor of anesthesiology at the UW School of Medicine and Public Health.
UW is an ideal fit for these trials given the skill of researchers and clinical trials personnel in working with industry, their capability to initiate trials thoroughly yet quickly and previous work with COVID-19 research, according to Betsy Nugent, director of clinical trials development and accreditation/chief clinical research officer at SMPH.
“We are excited to be part of these antibody clinical trials,” she said. “We must be cautious with our expectations, but we are aware of the importance of developing a potentially life-saving treatment and possibly preventative measure against this pandemic.”