COVID-19, Research & Technology
Spectrum Health Offers COVID-19 Treatments to Promote Recovery
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 email@example.com
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
- COVID-19 related symptoms have been present for less than 10 days
- Patient is not hospitalized
- 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.”
*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.
Spectrum Health System, a not-for-profit, integrated health system, is committed to improving the health and wellness of our communities. We live our mission every day with 31,000 compassionate professionals, 4,600 medical staff experts, 3,300 committed volunteers and a health plan with more than 1 million members. Our talented physicians and caregivers are privileged to offer a full continuum of care and wellness services to our communities through 14 hospitals, including Helen DeVos Children’s Hospital, 150 ambulatory sites and telehealth offerings. We pursue health care solutions for today and tomorrow that diversify our offerings. Locally-governed and based in Grand Rapids, Michigan, our health system provided $550 million in community benefit in calendar year 2019. Thanks to the generosity of our communities, we received $37 million in philanthropy to support research, academics, innovation and clinical care. Spectrum Health has been recognized as one of the nation’s 15 Top Health Systems by Truven Health Analytics®, part of IBM Watson HealthTM.