ACEP ID:

COVID-19 mAb Tool

Left Arrow Right Arrow Down Arrow Up Arrow Left Arrow Right Arrow Down Arrow Up Arrow
 
Section IconOverview
COVID-19 neutralizing monoclonal antibody (mAb) is used for treating COVID-19 positive patients who are non-hospitalized due to COVID-19 and/or at high-risk for progressing to severe COVID-19.
Administer neutralizing mAb treatment as soon as possible is recommended if your patient:
  • Has a positive viral test for SARS-CoV-2
  • Is within 10 days of COVID-19 symptom onset
  • Adult or pediatric patient (≥ 12 years of age weighing ≥ 40kg)
  • At high-risk for progressing to severe COVID-19 and/or hospitalization (See High Risk Criteria section below)
  • Mild to moderate symptoms, not oxygen requiring
  • Not hospitalized
More Information about the use of neutralizing mAbs for COVID-19, click here.
Mechanism of action
  • Click here to learn more about how neutralizing mAbs prevent SARS-CoV-2 viral entry.
Neutralizing mab treatments under EUA
  • Click here to learn more about the neutralizing mAb options available under EUA.
See the latest NIH recommendations on neutralizing mAbs for COVID-19 here. .
Section IconHigh Risk Criteria
Adults: Patients ≥ 18 years of age who meet at least one of the following criteria
Have a body mass index (BMI) ≥ 35
Have chronic kidney disease
Have diabetes
Have immunosuppressive disease
Are currently receiving immunosuppressive treatment
Are ≥ 65 years of age
Are ≥ 55 years of age AND have
  • Cardiovascular disease, OR
  • Hypertension, OR
  • Chronic respiratory disease.
Pediatrics: Patients 12–17 years old (weighing ≥ 40kg) who meet at least one of the following criteria
Have chronic kidney disease
Have diabetes
Have immunosuppressive disease
Are currently receiving immunosuppressive treatment
BMI ≥ 85th percentile for their age and gender based on CDC growth charts
Sickle cell disease, OR
Congenital or acquired heart disease
Neurodevelopmental disorders, for example, cerebral palsy
A medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.
Section IconMild to Moderate Symptoms
Mild signs and symptoms
Fever
Cough
Sore throat
Malaise
Headache
Muscle pain
Nausea
Vomiting
Diarrhea
Loss of taste and smell
They do not have shortness of breath, dyspnea on exertion, or abnormal imaging.
Moderate COVID-19 illness
Evidence of lower respiratory disease during clinical assessment or imaging, AND
Have a saturation of oxygen (SpO2) ≥ 94% on room air at sea level
Additional Info …
Information about the COVID-19 clinical spectrum, click here.
MDCalc’s covid triage calculator
Section IconFAQs
Why use neutralizing mAbs in high-risk patients with COVID-19?
Neutralizing mAbs have the potential to reduce hospitalizations compared to placebo in multiple ongoing studies. Click below to read more about the current published clinical efficacy and safety results for neutralizing mAbs. Learn More.
What are the risks of neutralizing mAb infusions that I should discuss with my patients?
Hypersensitivity and infusion-related reactions have occurred. Serious and unexpected adverse events may occur that have not been previously reported.
Click here to learn more in the section titled: “Can antibody treatment make me sick?”
How long will it take for my patients to receive the neutralizing mAb infusion?
Depending on the neutralizing mAb treatment they receive, the whole process could take up to 2 to 3 hours.
Click here to learn more in the section titled: “What can I expect from treatment (infusion)?”
Where can I send my patients to get a neutralizing mAb infusion?
Click here to learn more.
Will my patients have to pay for this infusion?
Many eligible patients pay no out-of-pocket costs for antibody treatment, although health care institutions may charge a fee for administration of the treatment. learn more.
If my patient is vaccinated and tests positive for COVID-19, can they still receive neutralizing mAb treatment?
Yes. Click here to learn more in the section titled: “Vaccinated people who subsequently develop COVID-19”.
Can COVID-19 vaccine be given to patients who have received neutralizing mAbs for treatment of COVID-19?
Section IconEmergency Use Authorization (EUA)
Important Information …
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an EUA is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases when there are no adequate, approved, and available alternatives.
Products authorized for emergency use under an EUA are not considered approved and are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner.
For more information about EUAs, click here to learn more from the FDA.
Click here for FDA Bamlanivimab and Etesevimab EUA
Click here for FDA Sotrovimab EUA.
Updated EUA with FDA authorization of REGEN-COV (casirivimab and imdevimab, administered together) lower dose (1,200 mg) – half the originally authorized dose – which can be administered as an IV infusion or notably, via subcutaneous injection, when IV infusion is not feasible and would lead to a delay in treatment. Click here for Update EUA
  Back To Top

Acknowledgments

CONTRIBUTORS
Sandra Schneider, MD, FACEP Sam Shahid, MBBS, MPH

 

ACEP Staff
Liz Muth

 

FEEDBACK
Questions, Contact us today!

 

Supported by a contribution from Lilly.

 

Publisher’s Notice

The American College of Emergency Physicians (ACEP) makes every effort to ensure that contributors and editors of its resources are knowledgeable subject matter experts and that they used their best efforts to ensure accuracy of the content. However, it is the responsibility of each user to personally evaluate the content and judge its suitability for use in his or her medical practice in the care of a particular patient. Users are advised that the statements and opinions expressed in this resource are provided as recommendations of the contributors and editors at the time of publication and should not be construed as official College policy. ACEP acknowledges that, as new medical knowledge emerges, best practice recommendations can change faster than published content can be updated. ACEP recognizes the complexity of emergency medicine and makes no representation that this resource serves as an authoritative resource for the prevention, diagnosis, treatment, or intervention for any medical condition, nor should it be used as the basis for the definition of or the standard of care that should be practiced by all health care providers at any particular time or place. To the fullest extent permitted by law, and without limitation, ACEP expressly disclaims all liability for errors or omissions contained within this resource, and for damages of any kind or nature, arising out of use, reference to, reliance on, or performance of such information.

Copyright 2021, American College of Emergency Physicians, Dallas, Texas. All rights reserved. Produced in the United States of America. Except as permitted under the United States Copyright Act of 1976, no part of this resource may be reproduced or distributed in any form or by any means or stored in a database or retrieval system without prior written permission of the publisher.

Requests for permission should be sent here.

LIVE CHAT
[ Feedback → ]