Therefore, you may not administersotrovimabto treat COVID-19 under the EUA until further notice. But Regeneron Pharmaceuticals, maker of the only authorized, free monoclonal . Serious and unexpected side effects may happen. Prevention and early treatment for eligible patients can help improve patient outcomes, reduce stress on healthcare facilities, and even save lives. People who had severe illness with COVID-19 might experience organ damage affecting the heart, kidneys, skin and brain. Learn more about treatment guidelines and recommendations for using monoclonal antibody therapies. For more information about billing and payment for VEKLURY in the outpatient setting: Monoclonal Antibodies for Pre-Exposure Prophylaxis of COVID-19. Brobst B, Borger J. Molecular engineering has enabled the fine-tuning of monoclonal antibody (mAb) function to enhance their effects and to minimize immunogenicity and side effects. The antibodies range in effectiveness depending on type, but some have been shown in to reduce COVID-related hospitalization or death by up to 85%. Monoclonal antibodies are proteins developed in a lab in order to fight off infections that our bodies aren't familiar with, like COVID-19. bleeding or infection at the injection site. Beginning on May 6, 2021, Medicare established separate coding and payment for administering COVID-19 monoclonal antibody products through infusion in a patients home or residence. Healthcare providers should also be aware of the resistance of certain variants of the SARS-CoV-2 virus. [22] The EUA for sotrovimab is for a single dose of 500 mg IV.[12]. These monoclonal antibodies are usually given as an intravenous (IV) infusion at . A monoclonal antibody (mAb) is a type of immune protein produced in a lab that binds to a specific protein on a cell called an antigen . The antibodies . On April 5, 2022, the FDA announced that, Under the terms of the FDA approval and EUA, health care providers may only administer ACTEMRA (tocilizumab) to hospitalized patients with severe COVID-19 illness. We geographically adjust the rate based on where you furnish the service. Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial. Review the Antiviral Resistance information in the Fact Sheet for each monoclonal antibody therapy authorized under anemergency use authorization (EUA)for details regarding specific variants and resistance. On December 23, 2022, the. COVID-19 therapeutics can be used to prevent or treat eligible non-hospitalized patients who have tested positive for COVID-19 and have mild to moderate symptoms. Clinical development methodology for infusion-related reactions with monoclonal antibodies. Sotrovimab targets a highly conserved epitope of the RBD that is present across the entire family of SARS-like coronaviruses. Mitj O, Corbacho-Monn M, Ubals M, Alemany A, Suer C, Teb C, Tobias A, Peafiel J, Ballana E, Prez CA, Admella P, Riera-Mart N, Laporte P, Mitj J, Clua M, Bertran L, Sarquella M, Gaviln S, Ara J, Argimon JM, Cuatrecasas G, Caadas P, Elizalde-Torrent A, Fabregat R, Farr M, Forcada A, Flores-Mateo G, Lpez C, Muntada E, Nadal N, Narejos S, Nieto A, Prat N, Puig J, Quiones C, Ramrez-Viaplana F, Reyes-Uruea J, Riveira-Muoz E, Ruiz L, Sanz S, Sents A, Sierra A, Velasco C, Vivanco-Hidalgo RM, Zamora J, Casabona J, Vall-Mayans M, Gonzlez-Beiras C, Clotet B., BCN-PEP-CoV2 Research Group. Ju B, Zhang Q, Ge J, Wang R, Sun J, Ge X, Yu J, Shan S, Zhou B, Song S, Tang X, Yu J, Lan J, Yuan J, Wang H, Zhao J, Zhang S, Wang Y, Shi X, Liu L, Zhao J, Wang X, Zhang Z, Zhang L. Human neutralizing antibodies elicited by SARS-CoV-2 infection. [17], Like other RNA viruses, there is a high potential for mutation, and several variants of SARS-CoV-2 have been identified. Monoclonal Antibodies to Treat Mild-to-Moderate COVID-19. [27], Analysis by Stokes et al. If you administer these COVID-19 monoclonal antibody products in Medicare patients in traditional health care locations (for example, a hospital outpatient infusion clinic or freestanding infusion clinic), continue to bill HCPCS code M0220, as applicable. There are specific conditions people need to meet in order to receive the medication. Sotrovimab contains a mutation in its fragment crystallizable(Fc) region that gains an extended half-life and enhances distribution to the lungs. Official websites use .govA The authorized dose for REGEN-COV for. For most Medicare Advantage hospice patients, submit claims to Original Medicare. ) bruising of the skin. Monoclonal antibodies, . Medicare Part B will provide payment for the drug and its administration under the applicable Medicare Part B payment policy when you provide it in the outpatient setting, according to the FDA approval. The cause wasdemonstrated to be anovel coronavirus, called the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The highly contagious nature of the virus and its high potential for morbidity and mortality has overwhelmed hospital systems worldwide with hospitalizations and deaths. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. Patients of older age with comorbidities such as cardiovascular disease, obesity, diabetes, chronic kidney disease, and chronic lung disease are at much higher risk of developing severe symptoms and requiring hospitalizations than younger healthy individuals. [5][6], Monoclonal antibodies have been identified as a potential therapy to prevent disease progression in patients at risk for severe disease. Although the Food and Drug Administration gave these treatments like Regeneron emergency use authorization in 2020, the criteria for who is eligible to receive them has expanded. Choi JC, Kim WY. http://creativecommons.org/licenses/by-nc-nd/4.0/. Shepard HM, Phillips GL, D Thanos C, Feldmann M. Developments in therapy with monoclonal antibodies and related proteins. Therefore, youmay not administerREGEN-COVfor treatment or post-exposure prevention of COVID-19 under the EUA until further notice. A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19. Former President Donald . After binding the ACE2 receptor, the virus can gain entry to the cell, and viral replication can occur. Monoclonal antibody therapy reduces deaths and hospitalizations in non-hospitalized patients with risk factors for severe disease progression. On January 24, 2022, the FDA announced that, REGEN-COV (casirivimab and imdevimab, administered together) (EUA issued November 21, 2020, latest update January 24, 2022). Providers and suppliers who administer REGEN-COV for PEP should use M0243 or M0244 for administering the first dose and M0240 or M0241 for administering subsequent repeat doses. [25][26]One percentof the patients who received sotrovimab had infusion-related reactions. At high risk of dying from the virus, Barron remains a virtual prisoner in her . N.Y.C.'s Mandate: New York City will end its aggressive but contentious vaccine mandate for municipal workers, Mayor Eric Adams announced, signaling a key moment in the city's long battle . [6] On April 5, 2022, the FDA announced that, due to the high frequency of the Omicron BA.2 sub-variant, sotrovimab isnt currently authorized in any U.S. region. Most infusion-related reactions are self-limited and treated by stopping the infusion and symptomatic treatment. Sotrovimab is not authorized for subcutaneous administration. Monoclonal antibody therapy is not indicated in severe cases requiring hospitalization. Monoclonal antibodies prevent progression to severe disease, are not equally effective across variants, and are associated with minimal and self-limited reactions. Management and preparedness for infusion and hypersensitivity reactions. The FDA authorized the use of these monoclonal antibody therapies to treat mild-to-moderate COVID-19 in adults and pediatric patients when both of these apply: The patient has a positive COVID-19 test result The patient is at high risk for progressing to severe COVID-19, hospitalization, or both This requires equipment and medications used for the immediate treatment of allergic reactions including, antihistamines, antiemetics, epinephrine, blood pressure monitoring, and stethoscopes. Infusion-related reactions typically present after 30to 60 minutes after initiating the infusion. You can treat symptoms with over-the-counter medicines, such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil), to help you feel better. We geographically adjust the rate based on where you furnish the service. Bamlan and etesev infus home, Note: This product isnt currently authorized[6], Long descriptor: Injection, sotrovimab, 500 mg, Long Descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring, Long Descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-based to the hospital during the COVID-19 public health emergency, Short Descriptor: Sotrovimab inf, home admin, Genentechs Antibody ACTEMRA (tocilizumab), Long descriptor: Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, 1 mg, Short descriptor: Tocilizumab for COVID-19, Long Descriptor: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, first dose, Short Descriptor: Adm Tocilizu COVID-19 1st, Long descriptor: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, second dose, Short descriptor: Adm Tocilizu COVID-19 2nd, AstraZenecas Antibody EVUSHELD (tixagevimab and Cilgavimab)Note: This product isnt currently authorized[8], Long descriptor: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 300 mg, Long descriptor: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring, Long descriptor: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-based to the hospital during the covid-19 public health emergency, Short descriptor: Tixagev and cilgav inj hm, Long Descriptor:Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 600 mg, Short Descriptor:Tixagev and cilgav, 600mg, Long descriptor:Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring, Long descriptor:Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-based to the hospital during the covid-19 public health emergency, Short descriptor:Tixagev and cilgav inj hm, Eli Lilly and Companys Antibody Bebtelovimab (PDF), Note: This product isnt currently authorized[7], Long descriptor:Injection, bebtelovimab, 175 mg, Long Descriptor:Intravenous injection, bebtelovimab, includes injection and post administration monitoring, Long Descriptor:Intravenous injection, bebtelovimab, includes injection and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-basedto the hospital during the covid-19 public health emergency, Short Descriptor: Bebtelovimab injection home. The interprofessional healthcare team is also responsible for educating the patient on infection control measures. These are not all the possible side effects of this medication, which has not been given to a lot of people. Vaccines prevent progression for a larger part of the population. pain. As more data is released and reviewed, the current recommendations regarding monoclonal antibody therapy may change. The effects also could lead to the development of new conditions, such as diabetes or a heart or nervous . [23][24]Infusion-related reactions are characterized by flushing, fever/chills, back or abdominal pain, nausea/vomiting, pruritus, or skin rashes. In December of 2019, an outbreak of severerespiratory infections was noticed in Wuhan, China. This rate reflects updated information about the costs involved in furnishing these complex products in a patients home. However, if the patient is only in that location temporarily (such as if your patient has a permanent home but is in a post-acute stay in a skilled nursing facility), the setting isnt considered a patients home or residence for this purpose, and you shouldnt bill for the higher at home HCPCS codes M0241, M0244,M0246, M0248, or M0223. CMS geographically adjusts the rate based on where you furnish the service. In: StatPearls [Internet]. Continue to use the same codes to bill for administering bamlanivimab and etesevimab for PEP and treatment: Effective February 11, 2022, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products by intravenous (IV) injection. Swollen lips, face or throat. Monoclonal antibodies are lab-made proteins that mimic the immune system's ability to fight off viruses and other harmful pathogens, per the FDA. In August, Florida launched the first mobile unit to provide monoclonal antibody treatments for coronavirus patients. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion, authorized or approved by the FDA, is approximately $450. Because CMS considers monoclonal antibody products to treat COVID-19 to be COVID-19 vaccines, they arent eligible for the New COVID-19 Treatments Add-on Payment (NCTAP) under the Inpatient Prospective Payment System (IPPS). An official website of the United States government Effective January 1 of the year after that in which the EUA declaration ends: On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. In the same patient population, mortality was also greatly increased compared to younger healthy individuals (19.5% vs. [2]On July 30, 2021, the FDA revised the EUA for REGEN-COV (casirivimab and imdevimab, administered together) to allow its use for post-exposure prophylaxis (PEP) in certain adult and pediatric patients. As newviral variants emerge, the spike neutralizing effects of monoclonal antibodies become more unclear. Antibodies to SARS-CoV-2, the virus that causes COVID-19, can be detected in the blood of people who have recovered from COVID-19 or people who have been vaccinated against COVID-19. Not many people have received bebtelovimab. With the dominance of this variant in the United States and the lack of readily available testing to identify the infecting variant, the FDA recommended against the use of any monoclonal antibody at this time except sotrovimab. The July 30, 2021, revised EUA for casirivimab and imdevimab allows for its use for post-exposure prophylaxis (PEP) for certain patients who have been exposed to (or are at high risk of exposure to) a person with COVID-19. Although the Food and Drug Administration gave these treatments . Find More Information about COVID-19 COVID-19 Vaccines Exposed to COVID-19 People With a Weakened Immune System Monoclonal antibodies are administered either subcutaneously or as an intravenous infusion. In the clinical trial, molnupiravir was given to study participants in four capsules twice a day for five daysstarting within five days after patients experienced the first symptoms of COVID-19.. Providers and suppliers should use Q0245 and M0245 or M0246 to bill for administering bamlanivimab and etesevimab for PEP. The chances of any of these side effects occurring after vaccination differ according to the specific vaccine. How you take it: Via injection or IV and administered only in a health care setting by a health care professional. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent in COVID-19, has created a global pandemic and overwhelmed hospital systems globally. These antibodies are typically. Bamlanivimab (EUA issued November 9, 2020, EUA revoked April 16, 2021). Inpatient locations, such as inpatient hospitals, inpatient psychiatric hospitals, long-term care hospitals, and inpatient rehabilitation hospitals, would never qualify as the home or residence for purposes of HCPCS codes M0241, M0244, M0246, M0248, or M0223. Nursing staff should be aware of the proper preparation of the medications and the recommended infusion rates. Prajapat M, Handa V, Sarma P, Prakash A, Kaur H, Sharma S, Bhattacharyya A, Kumar S, Sharma AR, Avti P, Medhi B. Update on geographical variation and distribution of SARS-nCoV-2: A systematic review. People at risk of getting very sick from COVID-19 include: People who are age 65 or older. Several potential outpatient therapies have been suggested as a way to treat symptoms and prevent progression to severe disease, including colchicine,hydroxychloroquine,inhaled corticosteroids,ivermectin,and fluvoxamine. Convalescent plasma has side effects like monoclonal antibodies, but with more infusion reactions and less efficacy. .gov The antibodies themselves are proteins, so giving them can sometimes cause something like an allergic reaction. The expert clinicians agree that my best hope is Humira (generic name, adalimumab), one in a class of drugs known as monoclonal antibodies that block the immune system proteins that make joints . In clinical trials, mAb (Casirivimab/Imdevimab) treatment reduced the risk of hospitalization by 50% in patients with mild to moderate COVID-19. The effective management of COVID-19 with monoclonal antibodies and ensuring patient safety requires the coordinated efforts of an interprofessional healthcare team, including clinicians (MDs, DOs, NPs, PAs), specialists (e.g., infectious disease specialists, virologists), pharmacists, nurses, and medical assistants. Watch for Eli Lilly to release more information about future batch numbers. People who are overweight (with a BMI of 26 or greater). For more information about the limits of authorized use for these monoclonal antibody therapies, including information about viral variants and antiviral resistance, review the following: The virus that causes COVID-19 (SARS-CoV-2) is constantly changing, and CDC expects new viral variants to continue to emerge. Think of them as reinforcements from someone who had more time to build up defenses against COVID-19 which your immune system can benefit from earlier on. Xia ZN, Cai XT, Cao P. Monoclonal antibody: the corner stone of modern biotherapeutics. Monoclonal Antibodies to Treat Mild-to-Moderate COVID-19 The FDA approved or authorized under EUA the following additional investigational monoclonal antibody therapies: ACTEMRA (tocilizumab) (EUA issued June, 24 2021, latest update December 21, 2022). Under the terms of the FDA approval and EUA, health care providers can only administer ACTEMRA (tocilizumab) to hospitalized patients in limited clinical situations. Medicare also pays for treatment to address major complications: For COVID-19 monoclonal antibody products administered before May 6, 2021, the Medicare payment rate is approximately $310. For more information about viral variants in your area to help you make treatment decisions: Eligible administration sites must coordinate with their respective state or territorial health department to order these COVID-19 monoclonal antibodies: Get more information on the ordering process and reporting requirements. While individuals of all ages are at risk of contracting COVID-19 and developing severe disease, several risk factors have been identified that place patients at higher risk for morbidity and mortality. The most common side effects include allergic reactions, which include infusion related reactions, injection site reactions, brief pain, weakness and others. Healthcare providers must also educate the patient on symptoms that mark progression to severe disease and prompt the patient to return for reevaluation. For many providers and suppliers, we also geographically adjust this rate based on where you furnish the service. Then, your dose will be reduced to 300 mg every other week. In general, the more common side effects caused by monoclonal antibody drugs include: Allergic reactions, such as hives or itching Flu-like signs and symptoms, including chills, fatigue, fever, and muscle aches and pains Nausea, vomiting Diarrhea Skin rashes Low blood pressure Serious side effects The emergency use authorization(EUA) for sotrovimab is for use in non-hospitalized patients 12 years or older, weighing more than 40 kg, with mildor moderate symptoms, who have one or more risk factors for progression to severe disease. However, administration of mAbs carries the risk of immune reactions such as acute anaphylaxis, serum sickness and the generation of antibodies. [18]These variations have key mutations in the spike protein of the virus, and in some cases, such as the UK variant, make the virus 43to 82% more transmissible. "As you may know, Gov. Bamlanivimab and etesevimab, administered together (EUA issued February 9, 2021, latest update January 24, 2022). CMS will continue to pay for COVID-19 monoclonal antibodies for post-exposure prophylaxis or for treatment of COVID-19 under the Medicare Part B vaccine benefit through the end of the calendar year in which the EUAdeclaration for COVID-19 drugs and biologicalsends. Researchers founda reduction in combined hospitalizations and death with 1% in the treatment group and 7% in the placebo group. COVID-19 Transmission, Current Treatment, and Future Therapeutic Strategies. Monoclonal antibodies, however, are produced by a single B-lymphocyte clone and are highly specific for their target antigen. The goal of this therapy is to help prevent hospitalizations, reduce viral loads, and lessen symptom severity. When administering monoclonal antibodies, theinterprofessional team must be prepared for adverse events such as transfusion reactions and anaphylaxis. Essentially, monoclonal antibody therapy for viral infection involves generating an antibody molecule type that reacts with the virus. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. Identify the potential adverse reactions to monoclonal antibody therapy in the management of outpatient COVID-19. More Information about Payment for Infusion & IV Injection at Home. Governor Ron De Santis touted it as an " early treatment for keeping people out of the hospital and reducing mortality.". This activity outlines the indications, actions, contraindications, and adverse events for monoclonal antibody therapy as a valuable treatment for outpatient COVID-19 infections. Monoclonal antibodies are intended to trigger the immune system and, in doing so, the body may respond with flu-like symptoms. Serious side effects were rare in Evusheld's PROVENT trial, although some participants experienced serious cardiac adverse events, including myocardial infarction and heart failure. The federal government isnt purchasing VEKLURY. Hoffmann M, Kleine-Weber H, Schroeder S, Krger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Mller MA, Drosten C, Phlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. The name of the provider who ordered or decided to administer the infusion or injection, even in cases where providers use roster billing to submit claims for these services, Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs), Through the end of the calendar year in which the EUA declaration ends for monoclonal antibody products used for post-exposure prophylaxis or for treatment of COVID-19, Permanently for covered monoclonal antibody products used as pre-exposure prophylaxis for prevention of COVID-19. Pregnant people. The federal government isn't distributing the following products; you may purchase them through typical purchasing channels: Medicare will cover and pay for the administration of monoclonal antibodyinfusions and injectionsused for post-exposure prophylaxis or treatment of COVID-19(when furnished consistent with their respective approvals or EUAs) the same way it covers and pays for COVID-19 vaccines until the end of the calendar year in which the EUA declaration for COVID-19 drugs and biologicals ends. We allow Medicare-enrolled immunizers including, but not limited to, pharmacies working with the U.S., infusion centers, and home health agencies to bill directly and get direct payment from the Medicare Program for vaccinating Medicare SNF residents. Get the most currentlist of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products. [1]Since its initial identification,SARS-CoV-2 has spread worldwide and incited a global pandemic. Healthcare providers should also educate the patients on the potential benefits of monoclonal antibody therapy for the treatment of COVID-19. In response to the COVID-19 PHE, the governmentinitially purchased the COVID-19 monoclonal antibody products and made them available for free. If the Batch # is D534422, the product was commercially-purchased. StatPearls Publishing, Treasure Island (FL). Monoclonal antibodies targeting the spike protein of the SARS-CoV-2 have yielded positive in vitro results. [1]On January 24, 2022, the FDA announced that, due to the high frequency of the Omicron variant, REGEN-COV (casirivimab and imdevimab, administered together) isnt currently authorized in any U.S region. Monoclonal antibodies are one such treatment that may . Gao YD, Ding M, Dong X, Zhang JJ, Kursat Azkur A, Azkur D, Gan H, Sun YL, Fu W, Li W, Liang HL, Cao YY, Yan Q, Cao C, Gao HY, Brggen MC, van de Veen W, Sokolowska M, Akdis M, Akdis CA. Risk factors for severe and critically ill COVID-19 patients: A review.