“Mabs” for COVID-19: Patient Assessment and Referral

(Updated June 10, 2021)

Monoclonal antibodies “mabs” are authorized in certain patients with a high-risk condition and mild to moderate COVID-19. Use of a “mab” infusion may prevent progression to severe COVID-19 and/or hospitalization when given early in the infection. Use this algorithm to help identify appropriate patients for potential use.

Initial assessment:2,3,5

  1. Does the patient have a documented positive VIRAL test for COVID-19?
    • If YES, continue to the next question.
    • □ If no, the patient does not qualify for a COVID-19 monoclonal antibody.
  2. Is the patient at least 12 years old?
    • If YES, continue to the next question.
    • □ If no, the patient does not qualify for a COVID-19 monoclonal antibody.
  3. Does the patient weigh at least 88 pounds (40 kg)?
    • If YES, continue to the next question.
    • □ If no, the patient does not qualify for a COVID-19 monoclonal antibody.
  4. Does the patient have mild or moderate COVID-19 symptoms that started no more than 10 days ago?
    • If YES, continue to the next question.
    • □ If no, the patient does not qualify for a COVID-19 monoclonal antibody.
  5. Does the patient require supplemental oxygen for COVID-19 (or more than baseline due to COVID-19 symptoms)?
    • If NO, continue to the next question.
    • □ If yes, the patient does not qualify for a COVID-19 monoclonal antibody.
  6. Does the patient require hospitalization, based on severity of COVID-19 symptoms?
    • If NO, continue to the next section to see if the patient has a qualifying high-risk condition?
    • □ If yes, the patient does not qualify for a COVID-19 monoclonal antibody.

Does the patient have at least ONE of the following high-risk conditions?2,3,5 (If YES, patient qualifies.)

  • For all patients who qualify based on the initial assessment above:
    • □ older age (e.g., ≥65 years old)
    • □ obesity or being overweight defined as body mass index (BMI):
      • ≥25 kg/m2 (adults)
      • ≥85th percentile for age and gender based on CDC growth chart (adolescents)
    • □ cardiovascular disease (including congenital heart disease)
    • □ chronic kidney disease (CKD)
    • □ chronic lung disease (e.g., COPD, moderate-to-severe asthma, cystic fibrosis, interstitial lung disease, pulmonary hypertension)
    • diabetes (type 1 or type 2)
    • □hypertension
    • □immunosuppressive disease or immunosuppressive treatment
    • □medical-related technologic dependence (e.g., tracheostomy, gastrostomy, positive pressure ventilation [not related to COVID-19])
    • □conditions involving metabolic complexity (e.g., genetic or metabolic syndromes and severe congenital abnormalities)
    • □ neurodevelopment disorders (e.g., cerebral palsy)
    • □ pregnancy
    • □ sickle cell disease
    • □ other conditions/factors making the patient high risk for severe COVID-19 (e.g., race, ethnicity)

Help patients make an informed decision about receiving “mab” treatment.

  • Explain the possible benefit (reducing the risk of progression to a severe COVID-19 infection) and risks associated with monoclonal antibody treatment.
    • □ Allergic reactions (e.g., fever, chills, shortness of breath, wheezing) are rare.1 However, explain to patients that they will need to be observed for about one hour after completing the monoclonal antibody infusion (which can take up to one hour) to monitor for a possible reaction.2-5
  • Make sure patients understand that treatment with a monoclonal antibody does not cure COVID-19.1
    • □ Advise patients they will need to continue to use infection control measures and isolate according to current health department guidance.1-3,5
  • There are not enough data available to assess possible risks associated with use of monoclonal antibodies in pregnant or lactating mothers. Discuss with patients individually. Only use monoclonal antibodies when the potential benefit (reduced disease severity) outweighs the risks (unknown).1-3,5

What monoclonal antibody dose should be used to treat mild or moderate COVID-19?

Where can patients receive monoclonal antibody infusions for COVID-19?

References

  1. American Pharmacists Association. Pharmacists’ referrals for monoclonal antibody treatment: assessing patients for potential COVID-19 treatment with monoclonal antibodies. February 25, 2021. https://aphanet.pharmacist.com/sites/default/files/audience/APhACOVID-19MAB0221_web.pdf. (Accessed May 27, 2021).
  2. FDA. Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Revised May 14, 2021. https://www.fda.gov/media/145802/download. (Accessed May 27, 2021).
  3. FDA. Fact sheet for health care providers: emergency use authorization (EUA) of REGEN-COV (casirivimab and imdevimab).  June 2021. https://www.fda.gov/media/145611/download. (Accessed June 9, 2021).
  4. HHS ASPR TRACIE. Planning considerations for monoclonal antibody administration. Updated February 10, 2021. https://files.asprtracie.hhs.gov/documents/aspr-tracie-covid-19-monoclonal-antibody-therapy-tip-sheet.pdf. (Accessed May 27, 2021).
  5. FDA. Fact sheet for healthcare providers emergency use authorization (EUA) of sotrovimab. May 2021. https://www.fda.gov/media/149534/download. (Accessed May 27, 2021).

Cite this document as follows: Clinical Resource,“Mabs” for COVID-19: Patient Assessment and Referral. Pharmacist’s Letter/Prescriber’s Letter. April 2021. [370402]

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