The Food and Drug Administration (FDA) has updated its recommendations for monoclonal antibody therapy for the treatment of COVID-19 in patients at risk for severe disease. Adams Memorial Hospital had been offering bamlanivimab (BAM) antibody therapy and now will administer combination antibody therapy. This combination therapy, REGEN-COV (casirivimab-imdevimab), is used under Emergency Use Authorization. The single drug therapy was previously administered under a similar authorization. The hospital will only give monoclonal antibody therapy in combination therapy now. The hospital has administered monoclonal antibody therapy for months, originally on the medical/surgical floor and now through the Emergency Department.
REGEN-COV (casirivimab-imdevimab) are manmade human monoclonal antibodies directed against the spike protein of SARS-CoV-2 (the virus that causes COVID-19). They are designed to bind to the spiked protein on the virus, blocking its ability to enter human cells, thus neutralizing the virus. The body naturally produces antibodies to fight infection. Since SARS-CoV-2 is a novel (new) virus, people do not already have antibodies designed to deal with the infection (natural immunity). Antibody medications like REGEN-COV are manmade antibodies given through an infusion to help the body fight the infection faster than the body could do on its own. This kind of immunity is called passive immunity.
Clinical trials have shown that monoclonal antibody therapy in specific patient populations decreases the likelihood of developing serious complications of COVID-19 and may decrease the need for emergency care and hospitalization. The treatment is indicated for patients with mild-to-moderate disease who have a high risk for progressing to severe COVID-19 or needing hospitalization. The infusion must be given within 10 days of the patient’s first day of symptoms and works best the sooner it is given in the disease process. The treatment does not help patients who already have severe disease (patients who are hospitalized, have a new need for oxygen or are on chronic oxygen with increased needs). Patients who would qualify for therapy must meet the following criteria:
- Have a lab test that is positive for SARS-CoV-2 (COVID-19)
- Be 12 years of age or older with a weight over 88 pounds
- Have symptoms that started less than 10 days ago
- Have a high risk for developing complications:
- Age 65 or older (even without any chronic health problems)
- Adults of any age with any of the following conditions:
- Obesity (body mass index of 35 or more)
- Chronic kidney disease
- Chronic immunosuppression (from disease or treatment)
- Ages 55 or older WITH hypertension, cardiovascular disease or chronic lung disease
- Ages 12-17 WITH obesity or other specific chronic health conditions
Under the requirements of the Emergency Use Authorization, patients need to:
- Review the FDA fact sheet for patients, parents and caregivers, available at:
- Printed copy at the Primary Care office, Stat Care or Emergency Department
- FDA Fact Sheet link under the COVID-19 Treatment tab on hospital website
- Clicking the following links on any web browser
- Understand that there are alternatives to receiving monoclonal antibody therapy (supportive care)
- Understand that monoclonal antibody therapy with REGEN-COV is authorized for use under an Emergency Use Authorization
Frequently Asked Questions
A: The patient should eat a light meal before coming to the hospital as they will not be allowed to eat or drink while receiving treatment.
A: Yes, the patient will need a driver to drop them off and pick them up afterward. On arrival, the patient will remain in the car at the ambulance entrance to the hospital (there is a sign underneath the overhang showing where to park) and call the hospital (260-724-2145 ext. 11250). Please do not block the double doors leading to the ambulance entrance with your vehicle.
A: The staff will escort the patient to the infusion clinic location within the Emergency Department, and we will ask the driver to park the vehicle in the parking lot. All staff will be wearing appropriate personal protective equipment (PPE), and we require all patients receiving monoclonal antibody therapy to wear a KN95 mask while in the hospital (mask will be provided upon arrival). After arrival, the patient and hospital will review paperwork again.
A: The medication is infused over approximately 30 minutes, and then the patient is observed for an additional hour. Once everything is complete, the nurse will call the patient’s driver and escort the patient back to the ambulance entrance for pickup. The total time is variable, but plan on the whole process taking at least two hours.
A: Patients should continue to self-isolate and use infection control measures according to CDC guidelines. Patients should stay in contact with their primary health care provider to monitor progress and watch for complications.