Antibody Resource Guide

COVID-19 Antibody Treatment Resource Guide

The National Infusion Center Association has developed the resources described below in our antibody treatment resource guide to support prescribers, infusion providers, and patients in the safe and efficient use of COVID-19 antibody treatments.  These resources can be found in the COVID-19 Antibody Treatment Resource Center.

Locating Sites of Care

NICA COVID-19 Locator 

Use NICA’s COVID-19 Therapy Locator Tool to identify sites of care administering COVID-19 antibody therapies.

Prescribers & Patients: 

  • Simply enter your city and state or your zip code and click “search” 
  • Click on a location to view site details including phone number, hours of operation, website,  amenities, and more.  
  • If results do not populate for the area searched, try widening the search radius. If there are still no  results to display, contact your local/regional health authorities as your state may not have opted into our antibody therapy locator program yet. 

Infusion Providers: 

  • Be sure patients can find your infusion site by “claiming” your location and adding pertinent details  to the profile like phone number, hours of operation, amenities, and more.  
  • Consider using the URL field to direct prescribers and patients to pertinent information on your  center’s website, such as patient arrival instructions, required forms, etc.  
  • If you need assistance claiming your center or building out your profile, email [email protected].

This national map is maintained by the Department of Health and Human Services and displays locations that have received shipments of COVID-19 antibody therapies.  

  • If results do not populate for the area searched, try widening the search radius. If there are still no  results to display, contact your local/regional health authorities as your state may not have opted to have their antibody therapy locations displayed. 
  • It is important to note that locations are displayed based on the address where medication was  shipped (e.g., centralized pharmacy, warehouse) and may not reflect the location/address where  patient care is provided. 

COVID-19 Antibody Treatment Indication Checklist

This checklist is intended to help prescribers determine if treatment with COVID-19 antibodies is  authorized for use in accordance with the Emergency Use Authorization (EUA) requirements.  • If COVID-19 antibody treatment is not indicated, the checklist can be included in the medical  record to document the clinical decision-making process.  

  • If COVID-19 antibody treatment is indicated, the checklist can accompany the medication order to  document eligibility criteria and support medical necessity. Individual infusion site documentation requirements may vary

COVID-19 Antibody Treatment Order Set

An order set is developed for each approved COVID-19 antibody therapy and serves as the prescription  for treatment. 

  • Facilitates proper prescribing by capturing the necessary elements of a valid, complete COVID-19 antibody treatment infusion order 
  • Captures criteria for authorized use mandatory reporting requirements per EUA.  • Guides infusion clinician in safe administration by prompting best practices and adherence to  administration requirements.
  • Supports continuity of care by prompting the infusion provider to send records of completed  treatment to the prescriber. 

Coding Guide

List of common diagnosis codes that may apply to eligible patients.‡ 

  • Provides prescriber with easy access to codes needed to complete order set and indications  checklist 
  • ICD-10 data helps public health officials understand which patient populations are receiving  COVID-19 therapeutics to support efforts aimed at equitable allocation and distribution of  COVID-19 therapeutics. 

Referral Checklist

Many HCPs prescribing COVID-19 antibody treatments may be unfamiliar with the infusion referral  process. As COVID-19 antibody treatments are thought to be most effective when given as early as  possible in the disease course, it is critical to streamline the referral process to reduce unnecessary delays  to expedite access to treatment and optimize outcomes. This checklist provides a template overview of  necessary steps to refer a patient for COVID-19 antibody treatment. 

  • Infusion sites of care are encouraged to download and modify this checklist to create a custom  checklist including any unique, site-specific requirements. 

Patient Education: Preparing for a COVID-19 Antibody Infusion

Prescribers can provide and review this handout with patients to help them understand and prepare for  their infusion to promote treatment acceptance and adherence.  

  • Includes a field for prescriber to indicate facility name and phone number where referral/order  was sent, with instruction for patients to call if they have not received an appointment promptly.  This is intended to reduce treatment delays or patients “timing out” of treatment eligibility due to  communication challenges. 

Casirivimab + Imdevimab Flowsheet / Bamlanivimab Flowsheet

The flowsheet, sometimes called a treatment note, is used to document all care associated with  administration of COVID-19 antibody therapies.  

  • Guides the clinician to follow industry standards and best practices as well as adhere to  administration and documentation requirements under the EUA. This is not an all-inclusive list of diagnoses meeting EUA criteria for high risk for progressing to severe  COVID-19 and/or hospitalization.
  • Provides a detailed record to fax to the referring prescriber for inclusion in the patient’s medical  record.
  • Especially helpful for temporary sites of care or other infusion providers using paper  documentation. 

Drip Rate Tables

In sites of care administering infusions by gravity (as opposed to with an infusion pump or other rate control device), HCPs will be required to calculate the appropriate drip rate using the volume to be infused  and drop factor of the administration set used (infusion tubing). As many HCPs may be unfamiliar with the  calculations required, these tables provide the appropriate drip rates for administration of both products  using administration sets with any drop factor.

Casirivimab + Imdevimab Medication Safety Alert

Casirivimab and Imdevimab are supplied in multiple packaging configurations and have unique preparation  requirements that may increase risk for medication errors. 

  • Provides considerations and strategies to reinforce use of proper quantities/combinations of  product to prepare a single dose. 

Patient Education: COVID-19 Antibody Treatment Discharge Instructions

This patient handout explains signs and symptoms to watch for and report following a COVID-19 antibody  infusion.  

  • Provides home care instructions for discomfort at the IV site 
  • Reinforces the need to continue isolation to prevent disease transmission
  • Lists emergency warning signs that necessitate seeking medical attention

NICA Standards for In-Office Infusion

View NICA’s minimum standards for the administration of intravenous and injectable medication in an  outpatient setting. 

Eli Lilly Bamlanivimab Playbook

NICA collaborated with Eli Lilly to develop this playbook with in-depth information about preparation and  administration of bamlanivimab as well as other considerations for operationalizing an infusion site. 

Regeneron Casirivimab + Imdevimab Emergency Use Authorization (EUA) Guidebook

NICA collaborated with Regeneron to develop this playbook with in-depth information about preparation  and administration of casirivimab + imdevimab as well as other considerations for operationalizing an  infusion site. 

Report an Adverse Event to MedWatch

Healthcare providers must submit a report on all medication errors and all serious adverse events  potentially related to COVID-19 antibody therapy. 

Multilingual COVID-19 Resources

The CDC has developed the COVID-19 Communication Toolkit: For Migrants, Refugees, and Other  Limited-English-Proficient Populations in various languages. Resources are available in Spanish, Simplified  Chinese, Korean, Tagalog, Hmoob (Hmong), Af Soomaali (Somali), and Vietnamese.

Menu

Updates in the Treatment and Prevention of COVID-19​

Bebtelovimab Is the Only Monoclonal Antibody That Retains Activity Against Omicron Subvariants

The Omicron subvariants BA.2 and BA.2.12.1 now account for 99% of all COVID-19 cases in the United States. Studies assessing the neutralizing activity of monoclonal antibodies for the treatment of COVID-19 have found that only bebtelovimab retains activity against BA.2 and BA.2.12.1. Other monoclonal antibodies, including sotrovimab, bamlanivimab, etesevimab, casirivimab, and imdevimab, are not effective against these new subvariants and are not currently authorized by the US Food and Drug Administration (FDA) to treat COVID-19 due to the high incidence of Omicron BA.2.

Bebtelovimab is authorized for emergency use by the FDA for the treatment of mild-to-moderate COVID-19 in patients 12 years and older weighing at least 40 kg with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death. Bebtelovimab should be administered as soon as possible after positive SARS-CoV-2 results and within 7 days of symptom onset.

FDA Approves Baricitinib for Hospitalized COVID-19 Patients

Baricitinib, an oral Janus kinase (JAK) inhibitor, is now FDA-approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). It is also authorized for emergency use by the FDA for hospitalized pediatric patients between 2 and 18 years of age who require oxygen support. The approval of baricitinib is based on efficacy and safety data from the ACTT-2 and COV-BARRIER clinical trials. In ACTT-2, baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time, particularly in patients receiving high-flow oxygen or noninvasive ventilation (10 days vs 18 days; rate ratio for recovery, 1.51; 95% confidence interval (CI), 1.10 to 2.08). The 28-day mortality was 5.1% with baricitinib plus remdesivir and 7.8% with remdesivir alone (hazard ratio [HR] for death, 0.65; 95% CI, 0.39 to 1.09). The COV-BARRIER trial found that baricitinib, in addition to standard of care (SoC), was associated with reduced 28-day mortality in hospitalized adults with COVID-19 compared with SoC alone (8% vs 13%; HR, 0.57; 95% CI, 0.41 to 0.78; P= .0018). The 60-day all-cause mortality was 10% with baricitinib plus SoC versus 15% with SoC (P= .005).

References:
Baricitinib fact sheet for healthcare providers. May 2022. (https://www.fda.gov/media/143823/download).  Accessed 5.24.2022.

Baricitinib (Olumiant®) PI 2022 (https://pi.lilly.com/us/olumiant-uspi.pdf). Accessed 5.24.2022.

Bebtelovimab fact sheet for healthcare providers. May 2022. (https://www.fda.gov/media/156152/download).  Accessed 5.24.2022.

Centers for Disease Control and Prevention (CDC). COVID data tracker. May 23, 2022. (https://covid.cdc.gov/covid-data-tracker/#variant-proportions). Accessed 5.24.2022.

Iketani S, et al. Antibody evasion properties of SARS-CoV-2 Omicron sublineages. Nature. 2022;604:553-556.

Kalil AC, et al. Baricitinib plus remdesivir for hospitalized adults with COVID-19. N Engl J Med. 2021;384:795-807.

Marconi VC, et al. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. Lancet Resp Med. 2021;9:1407-1418.