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What You Need to Know About Treating COVID-19 With Monoclonal Antibodies

In November 2020, the United States Food and Drug Administration (FDA) issued emergency use authorization for monoclonal antibody infusion to treat COVID-19. The agency first authorized Eli Lilly’s bamlanivimab on November 9, followed by Regeneron Pharmaceuticals’ dual treatment of casirivimab and imdevimab on November 21.

But before you get too excited about the potential of these COVID-19 treatments, you need to understand that research into their effectiveness and safety is ongoing. They’re also not authorized for everybody. This means you can’t stop practicing mitigation strategies like wearing a mask, social distancing and hand-washing.

We know there’s a lot of information out there about monoclonal antibody infusion that can be hard to understand. So, we dug into the FDA’s website and talked with OhioHealth’s system director of Infection Diseases Joseph Gastaldo, MD, to bring clarity in answering your top questions.

What are monoclonal antibodies?

Monoclonal antibodies are laboratory-made proteins that imitate an immune response, improving the body’s ability to fight off viruses. Bamlanivimab, casirivimab and imdevimab (try saying that three times fast!) are all monoclonal antibodies. These tongue twisters were created to target the COVID-19 virus’ SARS-CoV-2 spike protein, which helps the virus infect people.

The FDA approved emergency use authorization for two COVID-19 infusion therapies using monoclonal antibodies: one that only uses bamlanivimab, and another that combines casirivimab and imdevimab.

You can’t stop practicing mitigation strategies like wearing a mask, social distancing and hand-washing.


Bamlanivimab infusion

Bamlanivimab is a single-dose, intravenously (IV)-administered COVID-19 treatment.

What does the research show?

Bamlanivimab went through two phases of clinical trials. The second phase was randomized and double-blind, meaning neither the participant nor those running the study were aware of who received bamlanivimab or the placebo. There was a total of 465 participants, all with mild to moderate COVID-19 symptoms. When given within three days of symptom onset, this study suggested that bamlanivimab not only lowers the amount of virus present, or viral load, but also may help slow progression of COVID-19.

Who is included in the bamlanivimab emergency use authorization?

The emergency use authorization covers anyone who is 12 years or older, weighing at least 88 pounds, who received a positive SARS-CoV-2 test result and is at high risk for developing severe symptoms. This includes people 65 and older and those with preexisting, chronic medical conditions.

The treatment is not authorized for patients who have been hospitalized or require oxygen therapy due to COVID-19.


Casirivimab and imdevimab infusion

Casirivimab and imdevimab are simultaneously administered by IV in a single dose to treat COVID-19.

What does the research show?

Treatment with the combination of casirivimab and imdevimab was studied in one randomized, double-blind clinical trial. The study had 799 participants, all with mild to moderate COVID-19 symptoms. The results were similar to the bamlanivimab trials. Only 3% of the participants treated with casirivimab and imdevimab had to be hospitalized, compared to 9% of placebo-treated participants. The viral load in participants treated with casirivimab and imdevimab significantly decreased by the seventh day of the study. 

Who is included in the casirivimab and imdevimab emergency use authorization?

The emergency use authorization covers anyone who is 12 years or older, weighing at least 88 pounds, who received a positive SARS-CoV-2 test result and is at high risk for developing severe symptoms. This includes people 65 and older and those with preexisting, chronic medical conditions.

The combination treatment is not authorized for patients who have been hospitalized or require oxygen therapy due to COVID-19.

If you think you may have come into contact with someone who has COVID-19, call your primary care doctor or the Ohio Department of Health call center. The call center is now open seven days a week from 9 a.m. to 8 p.m. to answer your COVID-19 questions, and can be reached at 1 (833) 4-ASK-ODH (1 (833) 427-5634).

Want to learn more about monoclonal antibody infusion at OhioHealth? Check out our website or call (614) 544.4000, our phone line is open Monday-Friday 8am-4pm.

The information in this article was updated January 4, 2020. For the latest information about COVID-19, visit the Centers for Disease Control and Prevention’s (CDC)’s website.

 

 

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