UIC enrolls people into phase 3 monoclonal antibody clinical trial
Reviewed by Emily Henderson, B.Sc.Oct 30 2020
Researchers at the University of Illinois Chicago are now enrolling people into a phase 3 clinical trial that will test if a monoclonal antibody treatment — administered as a series of four shots — will help protect uninfected individuals from acquiring or getting sick from COVID-19 after someone in the household tests positive for COVID-19.
Antibodies are immune system molecules in the body that can attach to viruses and bacteria and stop them from spreading or causing illness. Antibodies typically develop only in reaction to being exposed to a specific pathogen, and this process in the body can sometimes take a few weeks.
Monoclonal antibodies are molecules made in a lab that act like antibodies made naturally by the immune system. And, like natural antibodies, monoclonal antibodies attach to a pathogen in the same way a key fits a lock. When the antibodies are attached, they diminish the ability of the pathogen to cause damage. Compared with natural antibodies, lab-made antibodies can be produced more quickly and can be engineered to be more potent.
The UIC clinical trial will test a specific combination of two monoclonal antibodies. This means that each of the two antibodies attaches to one specific location on the virus; each antibody is cloned so that many copies are present.
The monoclonal antibody combination — often referred to as a "cocktail" –was developed by Regeneron Pharmaceuticals, a biotechnology company based in Tarrytown, New York, and is called REGN-COV2. It is being studied at trial sites throughout the U.S.
We want to see if treating healthy people — those who do not currently have symptoms — who have been exposed to the virus through a household contact with a recent diagnosis of COVID-19 will be protected against the virus with this antibody cocktail. Compared to a vaccine, which is given to most people in a community, we are studying the antibody cocktail as a preventive treatment in cases of known close exposures.
Ideally, we want multiple levels of protection and treatment for the virus — even if a vaccine becomes available, it is still important that we have good medicines for providing added protection against the virus in cases of known exposures and treatments for people who may still get sick," Herrick said. "If found to be effective and safe, a monoclonal antibody treatment would, in essence, be like a specialized turbocharge to a person's immune system against COVID-19."
Dr. Jesica Herrick, associate professor of infectious diseases and principal investigator for the UIC study
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To enroll in the study, participants must be asymptomatic and must have close contact with someone who has tested positive for COVID-19, typically residing in the same household. Additionally, they must enroll in the study within four days of their housemate's positive COVID test. Participants must be 18 years or older and be otherwise in good or stable health.
UIC hopes to enroll 25 or more individuals into the phase 3 study, which is a randomized, double-blind, placebo-controlled trial. This means that half of the participants will get the antibody treatment and half will get a placebo, which is a multivitamin infusion designed to look similar to the antibody treatment. Neither the researchers nor the participants will know who gets the treatment and who gets the placebo.
Herrick and the UIC research team will follow the individuals with periodic visits for eight months.
Participants will have an initial in-person appointment, during which medical history and vitals will be taken, and the antibody shots will be administered. Participants will then have weekly appointments for a month with a clinical research team member followed by monthly appointments so that their health and symptoms can be monitored. Most of these appointments could be done in the participant's home if that is preferred.
"We still don't know enough about COVID-19, but clinical trials such as this one are the best way to understand how to effectively prevent and treat the virus," said UIC's Dr. Richard Novak, professor and head of infectious diseases and senior investigator of the UIC study. "We encourage anyone who has a close contact with a COVID-positive individual to consider participating in this clinical trial, or another like it. A treatment like this could be an important way to keep essential workers and their close contacts healthy in the face of this virus."