Workforce assessing if dual-antibody injection prevents COVID-19 sickness

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Mild COVID-19 cases can produce strong T cell response

Colored scanning electron microscope image of a cell (blue) that is heavily infected with SARS-CoV-2 virus particles (red) and isolated from a patient sample. Image taken at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Image Credit: NIAID

Combined antibody treatment for preventing COVID-19 disease in people who have been exposed to prolonged exposure to someone with the virus is being studied by researchers at the University of Texas Health Science Center at Houston (UTHealth). The clinical trial includes patients at Harris Health System's Lyndon B. Johnson Hospital.

The Phase III randomized, double-blind, placebo-controlled study will help researchers determine whether the laboratory-made double antibody treatment REGN-COV2 can prevent SARS-CoV-2 infection in people sharing a home with someone with a confirmed infection .

"If this study shows this treatment is effective, it can be used in a variety of settings where there is an increased risk of exposure, such as healthcare, airlines, meat packing factories, nursing homes, and first responders," said Dr. Roberto C. Arduino, the study's lead researcher and professor of infectious diseases at McGovern Medical School at UTHealth. "It is critical that we discover treatment options that can not only prevent serious illnesses but also stop the spread of COVID-19 in our communities."

The study team is attempting to enroll asymptomatic individuals who have been exposed for at least 48 hours to someone with a confirmed SARS-CoV-2 infection, known as an index case. Participants must be randomized within 96 hours of the index case being diagnosed. Study participants must live in the same household as the index case patient for 29 days during the study.

REGN-COV2 is a combination of two monoclonal (laboratory-made) antibodies that target two different sites on the spike protein that is on the surface of SARS-CoV-2, the virus that causes COVID-19. Antibodies are proteins that are made by the immune system to fight a pathogen or infection. The targeted surface spike protein gives the virus a crown-like appearance and enables it to attach to and invade cells.

The REGN-COV2 antibody cocktail is a combination of antibodies originally isolated from patients who have recovered from COVID-19 and produced by mice that have been genetically modified to have a human immune system.

The study period is 32 weeks. On the first day of admission, patients receive four subcutaneous injections of either the investigational agent or a placebo. This treatment strategy is known as "passive immunization" and is the current strategy for tetanus, rabies, hepatitis B and herpes zoster exposures. Participants will be tested for COVID-19 weekly for the first month of their enrollment.

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University of Texas Health Science Center at Houston

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Team Evaluates If Injection Of Two Antibodies Will Prevent COVID-19 Disease (2020, Sep 25)
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