Referring Pediatric Patients for COVID-19 Monoclonal Antibody Therapy

When is monoclonal antibody therapy used for COVID-19?

The FDA granted emergency use authorization (EUA) for bamlanivimab/etesevimab, casirivimab/imdevimab, bebtelovimab and sotrovimab for the treatment of mild to moderate COVID-19 in patients at high risk of severe disease. These products are not approved by the FDA for the treatment of COVID-19 and are still considered investigational drugs. Patients must meet specific criteria specified by the EUA to be considered for treatment with these investigational drugs. 

Clinical guidance

Review our guidance for the use of COVID-19 monoclonal antibody therapy for treatment or prophylaxis.

Get the guidance

Due to widespread transmission of the Omicron variant and subvariants and concerns for viral resistance, bamlanivimab/etesevimab, casirivimab/imdevimab and sotrovimab are not currently recommended for treatment or post-exposure prophylaxis. 

Bebtelovimab is currently only authorized for patients who are 12 years of age and older AND who weigh 40 kg (88 lbs) or more. Currently, we are not offering monoclonal antibody therapy for children younger than 12 years old or weighing less than 40 kg (88 lbs). Distribution and use will be prioritized and reserved for children at the highest risk for progression to severe disease or hospitalization. 

Please note: There is no available data for the efficacy of this experimental treatment in pediatric patients. We suggest reserving this therapy for the patients who are at highest risk of progression to severe disease or hospitalization. For more information about alternative treatment options, risk factors and whether your patient qualifies for monoclonal antibody therapy, please see our Acute COVID pathway and Use of COVID-19 Monoclonal Antibody Therapy for Treatment or Prophylaxis guidance document.  

Eligible patients who are over the age of 18 and currently receive care at Children’s Colorado for a chronic illness are also eligible able to receive monoclonal therapy through our Infusion Center. We are unable to provide monoclonal antibodies to adults who are not actively followed by one of our specialty clinics. 

A list of pharmacies and current stock is available on the CDPHE website. Monoclonal antibody therapy should generally be reserved as an alternative treatment option for outpatients who meet EUA criteria AND meet at least one of the following criteria: 

• Have an absolute contraindication to taking ritonavir-boosted nirmatrelvir due to a specific drug-drug interaction
• On a medication that has a serious drug-drug interaction with ritonavir-boosted nirmatrelvir and modification or monitoring of therapy is not possible 
• Known or suspected severe renal impairment (eGFR <30 ml/min)
• Known or suspected severe hepatic impairment (Child-Pugh class C)
• History of significant hypersensitivity reaction to the active ingredients or component of ritonavir-boosted nirmatrelvir 
• Unable to take pills or oral medication (crushing of ritonavir-boosted nirmatrelvir tablets is not recommended)  

Monoclonal antibody therapy for COVID-19 treatment

Currently, the authorized use of mAbs is limited to the treatment of mild to moderate COVID-19 for children ages 12 years or older who are at highest risk for progression to severe disease or hospitalization and who are within 7 days of symptom onset. 

Treatment may also be considered on a case-by-case basis for ages 12 years or older with mild to moderate COVID-19 who are at moderate risk for progression to severe disease or hospitalization and who are within 7 days of symptom onset. 

Mild to moderate COVID-19 is defined as having symptoms consistent with COVID-19 (such as runny nose, cough, congestion, fevers, etc.) but not requiring hospitalization or new oxygen support or an increase in baseline oxygen support due to COVID-19. 

Monoclonal antibody therapy for post-exposure prophylaxis

The only monoclonal antibody products that are currently authorized for post-exposure prophylaxis (bamlanivimab/etesevimab and casirivimab/imdevimab) are not likely to be active against the Omicron variant or subvariants and are therefore not recommend for use. Sotrovimab, bebtelovimab, and tixagevimab/cilgavimab are not authorized for post-exposure prophylaxis. 

Monoclonal antibody therapy for pre-exposure prophylaxis

Two monoclonal antibodies in combination, tixagevimab and cilgavimab (Evusheld), are available for pre-exposure prophylaxis for children who meet the eligibility criteria discussed below. This decision should be made in conjunction with the patient’s primary specialist. 

COVID-19 mAb therapy service at Children’s Colorado

Children’s Colorado offers monoclonal antibody therapy to eligible patients at our Infusion Center at the Anschutz Medical Campus. Limited appointments are available Monday through Friday.

Children’s Colorado providers and primary care physicians in the community can refer patients who test positive for COVID-19 and who meet the EUA criteria for monoclonal antibody therapy by filling out our REDCap survey. Please note, that while a patient may meet EUA eligibility criteria, only patients deemed to be at the highest risk based on local guidance will be prioritized for treatment. This is due to a limited supply of medication.

After completing the survey, providers will be notified of patient eligibility.

Next, if appointments are available, we’ll contact the patient family to gather more information and verify that they meet the EUA criteria for mAb therapy and answer any questions the family has about the treatment.

If we find that your patient meets criteria and there is appointment availability, we will schedule them for therapy. No further action is needed after you have filled out the survey.

How are monoclonal antibodies administered?

Bebtelovimab is only available as an IV injection given over 30 seconds. This therapy can only be administered at designated hospitals and infusion centers. 

Tixagevimab/cilgavimab (Evusheld) is administered as two separate intramuscular injections and can be administered in subspecialty clinics at Children’s Hospital Colorado. 

What are the EUA criteria for mAb treatment for COVID-19?

Patients must meet all of the following criteria based on existing EUAs:

• Age 12 years or older AND weigh 40 kg or more 
• Have mild to moderate symptomatic COVID-19 (i.e., not requiring hospitalization due to COVID-19 or no new or increased oxygen or respiratory support requirement due to COVID-19) 
• Are within 7 days of COVID-19 symptom onset 
• Have a positive result from direct SARS-CoV-2 testing (i.e., PCR or antigen) 
• Have at least one risk factor for progression to severe COVID-19 

What are the EUA criteria for mAb pre-exposure prophylaxis?

Patients must meet all of the following criteria based on existing EUAs: 

• Age 12 years and older AND weigh 40 kg or more 
• Are not currently infected with SARS-CoV-2 and have not had a known recent exposure to an individual infected with SARS-CoV-2 
• Have moderate to severe immunocompromise due to a medical condition or receipt of immunosuppressive therapy AND may not mount an adequate immune response to COVID-19 vaccination, OR are not able to receive an age-appropriate authorized or approved COVID-19 vaccine due to a history of a severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s) 

Please see the mAb guidance document for examples of severe and moderate immunocompromising conditions.

Additional resources for providers

• CDPHE website on COVID-19 treatments
• American Academy of Pediatrics FAQ on Outpatient Monoclonal Antibody Therapy
• ECHO Colorado A Provider’s Guide to Monoclonal Antibodies mAb Resources
• NIH Treatment guidelines
• NIH Guidance on Monoclonal Antibodies
• EUA Fact Sheets
  • Casirivimab/imdevimab
  • Bamlanivimab/etesevimab
  • Sotrovimab
  • Bebtelovimab
  • Ritnoavir-boosted nirmatrelvir (Paxlovid)
• NIH Statement on Prioritization of Monoclonal Antibodies When There Are Logistical Constraints
• Information for patients and families about mAb treatment at Children’s Colorado
• FDA Paxlovid eligibility screening checklist