COVID-19 treatments

Last updated July 27, 2021.

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Overview

COVID-19 monoclonal antibodies are neutralizing antibody treatments authorized by the FDA for emergency use. The treatments are available to people who have tested positive for COVID-19, exhibit mild to moderate symptoms of the disease, and who are at high risk of developing severe COVID-19.

Scientific studies show that high-risk COVID-19 patients treated with monoclonal antibodies were significantly less likely to progress to severe disease and/or hospitalization compared to patients who did not receive monoclonal antibodies.

Monoclonal antibody treatments involve the administration of one or a combination of monoclonal antibody products. The currently authorized treatments are REGEN-COV (casirivimab in combination with imdevimab) and Sotrovimab. Bamlanivimab alone is no longer used, and the distribution of bamlanivimab/etesevimab has been paused due to increased resistance in circulating coronavirus variants.

Monoclonal antibody treatments have been used for those individuals with an onset of symptoms within 10 days, who are not hospitalized, but are at high risk of developing severe COVID-19. 
The following medical conditions or other factors may place adults and pediatric patients (age 12-17 years and weighing at least 40 kg) at higher risk for progression to severe COVID-19:

  • Older age (≥65 years of age).
  • Obesity or being overweight (adults with BMI >25 kg/m, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts).
  • Pregnancy.
  • Chronic kidney disease.
  • Diabetes.
  • Immunosuppressive disease or immunosuppressive treatment.
  • Cardiovascular disease (including congenital heart disease) or hypertension.
  • Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension).
  • Sickle cell disease.
  • Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies).
  • Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation not related to COVID-19).

Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of monoclonal antibody treatment under the EUA is not limited to the medical conditions or factors listed above. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC’s website. Healthcare providers should consider the benefit-risk ratio for an individual patient. 

Monoclonal antibody treatments are not indicated for use on those who are hospitalized, on oxygen for COVID-19 treatment, or require an increase in baseline oxygen flow rate due to COVID-19.

If you have tested positive for COVID-19 and you are an individual at high risk of developing severe COVID-19 due to your age or medical condition, contact your provider to see if you are eligible for monoclonal antibody treatment. These outpatient treatments are administered intravenously (IV) or subcutaneously (SQ) at hospitals, outpatient infusion centers and doctors' offices. IV administration requires a single infusion, administered over an hour or less. SQ administration involves 4 injections. Both types of administration are followed by one hour of monitoring.

REGEN-COV is free. Sotrovimab is paid for through Medicaid, Medicare, and many health insurance plans. The administration fees for both treatments are also paid for through Medicaid, Medicare, and many health insurance plans.

Resources for further information on monoclonal antibody treatments:

FAQ

Extending access to COVID-19 monoclonal antibody treatment to all Coloradans is a goal and priority. Therefore, we have reached out to hospitals, infusion centers, and clinics statewide to identify their interest and capacity to administer these treatments. 

Check to see if you are eligible for COVID-19 monoclonal antibody treatment based on your COVID-19 test, your onset of symptoms, and your medical condition. If you are eligible, contact your health care provider.

Your health care provider can assess your symptoms, discuss the benefits and risks of monoclonal antibody treatment, and determine your eligibility to receive it.  If you agree to receive the treatment, your health care provider will write a prescription for you. Your health care provider (physician, advance practice nurse with prescriptive authority, or physician assistant) may then enter the prescription into the Department's COVID-19 Monoclonal Antibody Connector tool and you will be contacted by the hospital, infusion site, or clinic to schedule the treatment. 

Alternatively, your health care provider may provide you with a prescription for REGEN-COV or Sotrovimab,  and you will select and contact a site for administration of the treatment.

If you do not have a provider, the virtual health center at UC Health can confirm your eligibility for monoclonal antibody treatment, write you a prescription for the treatment, and help you locate a site to receive it.

All infusion sites seeking a supply of REGEN-COV and/or Sotrovimab must order the products directly from AmerisourceBergen Corporation (ABC), the sole distributor of these products.

Download information on how to order from ABC.

REGEN-COV is free of charge to requesting sites.

Step 1

Determine that your patient meets the eligibility criteria to receive the product. Eligible patients are those who are:

  1. Symptomatic with less than 10 days since symptom onset AND 
  2. At high risk.
    • The following medical conditions or other factors may place adults and pediatric patients (age 12-17 years and weighing at least 40 kg) at higher risk for progression to severe COVID-19:
      • Older age (≥65 years).
      • Obesity or being overweight (for example, adults with BMI >25 kg/m, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts).
      • Pregnancy.
      • Chronic kidney disease.
      • Diabetes.
      • Immunosuppressive disease or immunosuppressive treatment.
      • Cardiovascular disease (including congenital heart disease) or hypertension.
      • Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension).
      • Sickle cell disease.
      • Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies).
      • Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation not related to COVID-19).
    • Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19. Authorization of monoclonal antibody treatment under the EUA is not limited to the medical conditions or factors listed above. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC’s website. Healthcare providers should consider the benefit-risk for an individual patient.
  3. Have a positive Sars-CoV-2 PCR OR any antigen test that detects specific proteins from the virus.

This treatment is not authorized for use in patients 

  • who are hospitalized due to COVID-19, OR
  • require oxygen therapy due to COVID-19, OR
  • require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
Step 2

Decide which process you would like to follow in order for your patient to receive treatment. There are two processes available.

  • Complete the COVID-19 Monoclonal Antibody Connector tool 
    • The final page of the monoclonal antibody connector tool includes a list and map of current infusion sites registered with the state. You and your patient can select the patient’s closest or preferred location to receive treatment. The infusion site will be notified of the selection and will contact the patient to schedule treatment.
    • If the site selected is unable to accommodate your patient, you will be notified by the infusion site to select another location. When you have done so, you must notify the original infusion site in order for the patient’s record to be transferred to the new treatment location.
  • Provide your patient with a prescription for either REGEN-COV or Sotrovimab and discuss with the patient the potential administration sites the patient may contact to receive treatment.

Eligibility Determination

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