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You may call FirstCall Medical Center at 443-459-1095 (Monday – Friday from 8 a.m. to 5 p.m.) or the Maryland Department of Health-supported monoclonal antibody call center at 410-649-6122 (Monday – Friday from 8 a.m. to 5 p.m.).

When should you ask for monoclonal antibody treatment?

MAb treatment must be given within 7 days of a person’s first symptoms of COVID-19 or having been exposed to someone who has tested positive for COVID-19. The sooner a person receives mAb treatment, the better.

How do you get the monoclonal antibodies treatment?

To receive a mAb you should be referred for treatment by your healthcare professional and directed to available infusion locations. If you do not have a healthcare provider, call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585 to find out who to talk with about your symptoms and treatment.

Is monoclonal infusion still available?

Alternative monoclonal antibody therapies remain available under EUA. The FDA indicates that alternative monoclonal antibody therapies remain appropriate to treat COVID-19 patients, and health care providers may continue using these authorized therapies: Bebtelovimab.

Does monoclonal antibodies require a prescription?

Overview of Monoclonal Treatments – All treatments are neutralizing IgG1 monoclonal antibodies that bind to the receptor binding domain of the spike protein of SARS-CoV-2.They are investigational drugs and not currently approved for any indication. The data supporting the EUA for casirivimab/imdevimab was based on an interim analysis from a phase two randomized, double-blind, placebo-controlled clinical trial in non-hospitalized adults with mild to moderate COVID-19 symptoms.

The EUAs for sotrovimab and the combined treatment with bamlanivimab/etesevimab were based on phase III clinical trial data showing a reduction in hospitalizations in patients with mild to moderate COVID-19 symptoms. All treatments have been authorized for use by clinicians in an outpatient setting to treat mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization (e.g.

body mass index (BMI) ≥35, chronic kidney disease, diabetes, immunosuppressed, over 65 years of age). The antibody treatments will need to be mixed and transfused at health care facilities with this capability. The treatments are most effective early in the course of infection so they will need to be prescribed and dispensed within 10 days of symptom onset.

NOTE: bamlanivimab alone is not effective against the newer variants of SARS-CoV-2. The FDA has revoked its emergency use authorization for bamlanivimab alone. Read more, The combined treatment options of bamlanivimab/etesevimab and casirvimab/imdevimab are still available and authorized for use. Sotrovimab is another option that is available commercially under the conditions of the EUA.

The NIH treatment guidelines recommend use of bamlanivimab plus etesevimab, casirivimab plus imdevimab, or sotrovimab, for the treatment of outpatients with mild to moderate COVID-19 who are at high risk of clinical progression as defined by the EUA criteria.

1. New information: the FDA has authorized changes in the doses for casirivimab plus imdevimab from 2400 mg to 1200 mg (600 mg casirivimab and 600 mg imdevimab).
2. None of the treatments are authorized for use in patients who are hospitalized or experience anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.

Additional resources from HHS and ASPR include an allocation dashboard, distribution playbook, and information for clinicians. The treatment will be available with no out-of-pocket costs for patients. CPT codes will be issued for reimbursement of clinicians administering the infusion.

Do monoclonal antibodies work against Omicron?

Out of 102 monoclonal antibodies tested, only Cv2.1169 and Cv2.3194 cross-neutralized all variants of concern, including Omicron BA.1 and BA.2 subvariants. Monoclonal antibodies were once considered the gold standard of COVID-19 treatment. However, the emergence of the highly infectious Omicron variant rendered them largely ineffective.

The US Food and Drug Administration (FDA) even paused distribution of many monoclonal antibodies after Omicron became the dominant variant. One large-scale study of monoclonal antibodies, published in the Journal of Experimental Medicine, sought to determine if any were effective against COVID-19 variants of concern, including Omicron.

The research was led by the Institut Pasteur, Université Paris Cité, and the Institut national de la santé et de la recherche médicale (INSERM). “The broadly neutralizing antibodies we described were more efficient in vitro than many anti–SARS-CoV-2 monoclonals previously approved by the FDA for treatment or prevention,” said Hugo Mouquet, the head of the Laboratory of Humoral Immunology at the Institut Pasteur and a lead investigator of the study.

“Therefore, we are pretty confident that they represent premium candidates for pre-exposure prophylaxis in immunocompromised patients.” Long-term protection against severe COVID-19 is generated by memory B-cell and antibody responses to the virus’s spike protein. The investigators conducted a detailed characterization of 102 SARS-CoV-2 spike monoclonal antibodies, cloned from the memory B-cells of 10 COVID-19 convalescents.

Among all the monoclonal antibodies tested, only Cv2.1169 and Cv2.3194 cross-neutralized all variants of concern, including Omicron BA.1 and BA.2 subvariants. These were the most potent RBD-targeting antibodies. “One aspect of our work highlights the role of IgA antibodies for a broad SARS-CoV-2 neutralization,” Mouquet said.

When studying immune responses against pathogens affecting mucosal tissues, we thus consider that IgA-mediated antibody response should be systematically investigated, including in the quest of isolating broadly neutralizing monoclonal antibodies.” Cv2.1169 was isolated from a mucosa-derived, immunoglobin A, memory B cell, demonstrating potency boost as IgA dimers and therapeutic efficacy as IgG antibodies in animals.

Cv2.1169 is a type of antibody produced by B cells in the body’s mucosal tissues, including the respiratory tract, and may be crucial in ensuring early response to respiratory pathogens. These monoclonal antibodies may be especially beneficial in immunocompromised persons.

When do you start monoclonal antibodies for Covid?

Additional Considerations –

• For information on medical conditions and other factors that are associated with an increased risk of progression to severe COVID-19, see the CDC webpage, The decision to use anti-SARS-CoV-2 mAbs for a patient should be based on an individualized assessment of the risks and benefits.6 Not all of the conditions and factors considered to be high risk were well-represented in the clinical trials that provide support for the mAb EUAs.
  • Some rare medical conditions that are not listed on the CDC webpage and other factors (e.g., race, ethnicity) may be associated with a high risk of progressing to severe COVID-19. It is important to note that the likelihood of developing severe COVID-19 increases when a person has multiple high-risk conditions or comorbidities.7-10
  • Previously published clinical trials that evaluated the use of anti-SARS-CoV-2 mAbs for the treatment of COVID-19 largely enrolled an unvaccinated participant population. The risk of progression to severe COVID-19 in high-risk patients is substantially greater for those who are not vaccinated against COVID-19 and those who are vaccinated but do not mount an adequate immune response to the vaccine due to an underlying immunocompromising condition.
• If indicated, treatment with anti-SARS-CoV-2 mAbs should be started as soon as possible after SARS-CoV-2 infection is confirmed by an antigen test or a nucleic acid amplification test and within 7 days of symptom onset.
• Anti-SARS-CoV-2 mAbs should be administered in a setting where severe hypersensitivity reactions, such as anaphylaxis, can be managed. Patients should be monitored for at least 1 hour after the injection.
• See for the Panel’s recommendations in situations where therapies for the treatment of mild to moderate COVID-19, including anti-SARS-CoV-2 mAbs, cannot be offered to all eligible patients.
• Data are limited on the combined use of antiviral agents and anti-SARS-CoV-2 mAbs for the treatment of nonhospitalized patients with COVID-19. Clinical trials are needed to determine whether this combination therapy has a role in the treatment of COVID-19.
• Patients who are severely immunocompromised may have prolonged SARS-CoV-2 replication, leading to more rapid viral evolution. There is a concern that using a single anti-SARS-CoV-2 mAb in these patients may result in the emergence of resistant virus. Additional studies are needed to assess this risk.11,12

Can monoclonal antibodies be given at home?

Resources for PHYSICIANS. Home infusion pharmacists and nurses are specially trained in providing a wide range of IV treatments in the home setting, including monoclonal antibodies.

Is monoclonal free?

Are treatments available for COVID-19? – Yes! For people with certain underlying medical conditions, treatment with monoclonal antibodies is safe and effective at preventing hospitalization. This treatment is free through NYC Health + Hospitals, even if you do not have insurance.

1. New Yorkers may now present proof of a positive test — including at-home test results and test results from any external testing provider — at all mobile Test to Treat units to be evaluated for and prescribed COVID treatments on site.
2. Learn more,
3. If you are moderately or severely immunocompromised or unable to get vaccinated because you are allergic to the vaccine, talk to your doctor about Evusheld — an injectable drug that increases your protection against COVID-19.

Read more about Evusheld

Irving S. Martin