COVID-19 treatments

Last updated September 9, 2021.

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Overview

COVID-19 monoclonal antibodies can help prevent severe illness for some people who get infected with COVID-19. The FDA has authorized these neutralizing antibody treatments for emergency use. The treatments are available to people who have tested positive for COVID-19, have mild to moderate symptoms, and who are at high risk of developing severe illness.

Monoclonal antibodies are also available as post-exposure prophylaxis (prevention) for COVID-19 for people who are not fully vaccinated (or who may not be fully protected after vaccination,  such as people with immunocompromising conditions) and have been exposed to someone with COVID-19 and are at high risk of developing severe illness. They may also be used as a preventive treatment for people who are at high risk of exposure to COVID-19, such as an unvaccinated resident of a nursing home at which there is a new COVID-19 outbreak.

If you have tested positive for COVID-19 or are not fully vaccinated and have been exposed to COVID-19, and you are at high risk of developing severe COVID-19 due to your age or medical condition, contact your health care provider to find out if you are eligible for monoclonal antibody treatment.

Monoclonal antibody treatment is not a substitute for vaccination against COVID-19. Getting vaccinated is the best way to keep from getting sick with COVID-19.

Scientific studies show that high-risk COVID-19 patients treated with monoclonal antibodies were significantly less likely to get very sick and/or need to be hospitalized compared to patients who did not receive the treatments. Studies have also shown that being treated with monoclonal antibodies reduces the risk of getting COVID-19 if you have been exposed to a person testing positive for COVID and you are unvaccinated or partially vaccinated.

Monoclonal antibody treatments involve the administration of one or a combination of monoclonal antibody products. The currently authorized treatments are bamlanivimab/etesevimab, REGEN-COV (casirivimab in combination with imdevimab) and sotrovimab. REGEN-COV is the only treatment authorized to be used for prophylaxis in people exposed to COVID-19. Bamlanivimab/etesevimab was recently made available again in Colorado. It will remain available as long as variants resistant to it (B.1.351/Beta, P.1/Gamma, AY.1, AY.2, and B.1.621) comprise less than 5% of circulating variants. Find Colorado variant data on the COVID-19 data dashboard.

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

Resources for further information on monoclonal antibody treatments:

Monoclonal antibody treatments for people infected with COVID-19

Monoclonal antibody treatments are available for people who test positive for COVID-19 with an onset of symptoms within ten days, who are not hospitalized, but who 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 severe COVID-19. Authorization of monoclonal antibody treatment under the EUA is not limited to the medical conditions or factors listed above. For more information on medical conditions and factors associated with increased risk, see the CDC’s website. Health care 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.

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 four injections. Currently, only REGEN-COV is available for SQ administration. Both types of administration are followed by one hour of monitoring.

Monoclonal antibody treatments for those exposed to COVID-19 or who are at high risk of exposure to COVID-19

REGEN-COV is approved for use to prevent COVID-19 after exposure in adults and pediatric patients (age 12-17 years and weighing at least 40 kg) who:

  • Are at high risk of developing severe illness; AND

  • Are not fully vaccinated OR are not expected to adequately respond to a COVID-19 vaccination (for example, people with immunocompromising conditions and those taking immunosuppressive medications); AND

  • Have been exposed to an individual infected with COVID-19 consistent with close contact criteria per the CDC (someone who has been within six feet of an infected person for a total of 15 minutes or more over a 24-hour period) OR are at high risk of exposure to an individual infected with COVID-19 because of occurrence of COVID-19 infection in other individuals in the same institutional setting.

If you are not fully vaccinated for COVID-19 (or are concerned you may not respond adequately to a vaccine) and have been exposed to COVID-19, contact your health care provider to find out if you are eligible for monoclonal antibody treatment.

FAQ

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

Contact your doctor or health care provider for more information about COVID-19 monoclonal antibody treatment. You may be eligible for treatment based on your COVID-19 test, onset of symptoms, and medical condition, or based on your exposure risk and vaccination history.

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. 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 bamlanivimab/etesevimab, REGEN-COV, or sotrovimab. You may then choose a site to receive treatment.

  • Information on infusion sites, hospitals, and clinics that administer monoclonal antibody treatment and are registered with the state can be found on this Google map:
  • Information on sites that administer monoclonal antibodies but are not registered with the state can be located through The National Infusion Center Association or the HHS Protect Locator.
  • Information on administration sites in your county not registered with the state may be available through your local public health department.
  • Information on monoclonal antibody treatments and access to administration for all Coloradans can be found through the University of Colorado.

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

All infusion sites seeking a supply of bamlanivimab/etesevimab or REGEN-COV must order the product directly from AmerisourceBergen Corporation (ABC), the sole distributor.

Download information on how to order from ABC.

Bamlanivimab/etesevimab and REGEN-COV are free of charge to requesting sites. All sites ordering bamlanivimab/etesevimab and REGEN-COV are required to have an HHSProtect account and actively participate in current utilization reporting. For questions regarding ordering and distribution procedures, please contact COVID19therapeutics@hhs.gov. For assistance establishing an HHSProtect account, please contact  hhs-protect@teletracking.com.

Infusion sites seeking a supply of sotrovimab may order the treatment via the GlaxoSmithKline website.

STEP ONE

Determine that your patient meets the eligibility criteria to receive the product.

Eligible patients for monoclonal antibody treatments for people infected with COVID-19 are:

  1.  Adults and pediatric patients (age 12-17 years and weighing at least 40 kg)
  2. Symptomatic with less than 10 days since symptom onset AND 
  3. 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/m2 https://www.cdc.gov/growthcharts/clinical_charts.htm, 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.
  4. 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

Eligible patients for monoclonal antibody treatments for people exposed to COVID-19 or at high risk of exposure to COVID-19:

1. Are adults and pediatric patients (age 12-17 years and weighing at least 40 kg).

2. Are at high risk.

3. Are unvaccinated or not fully vaccinated (received last dose less than two weeks after a two-dose series or less than two weeks after a single-dose vaccine) OR are not expected to adequately respond to a COVID-19 vaccination (for example, people with immunocompromising conditions and those taking immunosuppressive medications); AND

4. Have been exposed to an individual infected with COVID-19 consistent with close contact as defined by the CDC (someone who has been within 6 feet of an infected person for a total of 15 minutes or more over a 24-hour period) OR are at high risk of exposure to an individual infected with COVID-19 because of COVID-19 infection in other individuals in the same institutional setting.
 

STEP TWO

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 preferred location to receive treatment. The 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 site in order for the patient’s record to be transferred to the new treatment location.
  • Provide your patient with a prescription for bamlanivimab/etesevimab, 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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