News Releases

Monoclonal antibodies used under FDA Emergency Use Authorization for non-hospitalized patients at risk for developing severe COVID-19 symptoms

GRAND RAPIDS, Mich., Feb. 2, 2021 – Spectrum Health West Michigan will open an infusion clinic at Spectrum Health Blodgett Hospital on Feb. 10 that uses monoclonal antibodies for the treatment of COVID-19 under a U.S. Food and Drug Administration Emergency Use Authorization.  

 The infusion treatment features Eli Lilly’s Bamlanivimab and Regeneron’s Casirivimab and Imdevimab combination. Bamlanivimab also is being used at Spectrum Health Lakeland to treat COVID-19 patients as part of their COVID-19 Medication Therapies program.  

 The infusion clinic at Blodgett Hospital replaces a smaller clinic that has been operating since December at the Spectrum Health medical center in downtown Grand Rapids. Developed with expertise and input from the Spectrum Health infectious disease team, the new clinic will provide more space and scheduling opportunities for treatment. 

 “At a time when a treatment for COVID-19 is at the forefront of everyone’s minds, Spectrum Health is excited to provide monoclonal antibodies to treat patients,” said Gordana Simeunovic, MD, Spectrum Health infectious disease expert. “The possibilities presented by these new treatments are encouraging. They are affordable, easy to administer and have been shown to have few side effects.” 

 Under the EUA, these treatments are designated for non-hospitalized patients in the early stage of COVID-19 with mild to moderate symptoms, and who are at risk for developing severe COVID-19 disease. 

 The infusion process in total is approximately three hours. Monoclonal antibody (MAB) treatment is given one time through a vein (intravenous or IV) for at least one hour. 

 Anyone who meets criteria can contact the COVID-19 Infusion Clinic for possible treatment at 616.391.0351 or covid19research@spectrumhealth.org  

 To be considered for this treatment option, patients must be 12 years of age or older and meet the following initial criteria: 

• Positive COVID-19 test  

AND 

• COVID-19 related symptoms have been present for less than 10 days 

AND 

• Patient is not hospitalized 

AND 

• One or more of the following risk factors for disease progression:  
  • Significant immunosuppression 
  • Morbid obesity 
  • Uncontrolled diabetes  
  • Chronic kidney disease 
  • Heart disease 
  • Lung disease 
  • Age 65 and older 

 Dr. Gordana notes for those who have questions about prioritizing between monoclonal antibodies and the COVID–19 vaccine that they are used for different purposes. “Monoclonal antibodies are given as treatment to already ill patients, while the vaccine is given to healthy people to prevent infection,” she said. “Treatment with MAB does not prevent you from getting a COVID-19 vaccine. The CDC simply recommends waiting 90 days after you receive MAB to get the COVID-19 vaccine.”  

 Click here and here for fact sheets offered to patients, parents and caregivers as well as an FAQ from the U.S. Food & Drug Administration.* 

 *Statements required by the U.S. Food and Drug Administration 

•  Bamlanivimab has not been approved, but has been authorized for emergency use by FDA, to treat mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
• Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• Casirivimab and imdevimab treatment has not been approved but has been authorized for emergency use by FDA under an EUA, to treat mild to moderate COVID19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. 
• The emergency use of casirivimab and imdevimab is only authorized for the
  duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner. 

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Media Relations
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Email: timothy.hawkins@corewellhealth.org