First Illinois Site to Begin Enrollment in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-5) Trial
Cook County Health is one of several major U.S. medical centers and the first site in Illinois to begin enrollment in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-5) – also known as the Big Effect Trial (BET-B). The study will evaluate potential antibody therapy drugs to help prevent the progression of COVID-19 in hospitalized, COVID-19 positive, non-pregnant adult patients requiring supplemental oxygen.
The adaptive, randomized, double-blind, placebo-controlled study will compare two combination therapies to a common control arm, with the goal of determining which experimental treatments show the greatest effect. Infectious disease researchers at Cook County Health will examine the efficacy, safety and tolerability of adding an anti-inflammatory monoclonal antibody therapy to the standard treatment of care for COVID-19 patients, which includes steroids and antiviral drugs.
“In response to the ongoing COVID-19 pandemic, there is an urgency to develop safe, effective methods to treat this virus, even as we continue to vaccinate people for COVID-19,” said Dr. Audrey French, an infectious disease physician and principal investigator at Cook County Health. “Our goal is to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies.”
The two different monoclonal antibody drugs being studied are lenzilumab and risankizumab. Lenzilumab is a monoclonal antibody developed to prevent inflammation associated with certain kinds of cancer immunotherapy. It targets granulocyte-macrophage colony stimulating factor (GM-CSF). Risankizumab is approved for the treatment of plaque psoriasis and targets interleukin-23 (IL-23), an inflammatory protein. High levels of both IL-23 and GM-CSF have been seen in complications affecting people with COVID-19.
“The hope is that by blocking these substances with targeted antibodies, we can prevent this damaging syndrome that can cause damage to the lungs and other organs in COVID-19 patients,” Dr. French added.
Study participants will get one of the anti-inflammatory monoclonal antibody therapeutic medications or a placebo in addition to receiving remdesivir and dexamethasone, the standard of care for COVID-19 patients. Up to two clinic visits will be required, and other visits will be conducted while participants are still hospitalized or over the telephone after discharge. Though the study, medication is given for only one day, the study follows participants for 60 days to document their recovery from COVID-19 and the safety of the drug.
The study is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. For more information about the study, visit clinicaltrials.gov.
Caitlin Polochak, Communications Manager