TIME TO EXPAND THE USE OF CASIRIVIMAB/IMDEVIMAB MONOCLONAL ANTIBODY THERAPY? A CASE OF COMPASSIONATE USE IN SEVERE COVID-19 PNEUMONIA

ABSTRACT

SESSION TITLE COVID-19 Case Report Posters 1 SESSION TYPE Case Report Posters PRESENTED ON 10/17/2022 1215 pm - 0115 pm INTRODUCTION: The FDA limits REGEN-COV (Casirivimab/Imdevimab) use to asymptomatic adults at high risk for progression to severe COVID-19 pneumonia or post-exposure prophylaxis. Here, we present a case of compassionate use of REGEN-COV in severe COVID-19 pneumonia. CASE PRESENTATION A 76-year-old male with a medical history significant for COPD, Rheumatoid arthritis (treated with hydroxychloroquine and low dose steroids), and monoclonal gammopathy of undetermined significance (MGUS) presented with one week of fever, cough, and fatigue. He was febrile to 103 F, with normal oxygen saturation on admission. SARS-CoV-2 rapid molecular PCR was positive. He was started on Levofloxacin, but he did not meet the criteria for administration of dexamethasone, remdesivir, or monoclonal antibody (mAb) therapy. On day one of admission, he became hypoxemic and was subsequently started on dexamethasone and remdesivir. He was given convalescent plasma to address inadequate antibody response to COVID-19 immunization secondary to his chronic immunosuppressed/immunodeficient state. His hypoxemia continued to worsen, requiring high-flow nasal cannula oxygen (HFNC). A regimen of tocilizumab was also initiated. CT chest angiography ruled out pulmonary embolism but revealed diffuse bilateral patchy opacities. His oxygen requirements continued to increase with decreasing ROX index and hence was transferred to the Intensive Care Unit. Repeat PCR for SARS-COV-2 was significant for a high viral load. Approval for compassionate use of REGEN-COV was obtained and administered to the patient. Following administration, his symptoms improved significantly with the transition from HFNC to simple nasal cannula oxygen. Repeat PCR for SARS-CoV-2 also showed a remarkable decline of the viral load. He was transferred back to the medical floors and later to the skilled nursing facility once he was clinically more stable. DISCUSSION: In the United States, REGEN-COV (Casirivimab/Imdevimab) treatment has been approved for emergency use since November 2020. The combination of these two neutralizing immunoglobulin gamma 1 (IgG1) mAb attacks the spike protein of the SARS-CoV-2 virus and has been shown to effectively prevent the progression of symptomatic COVID-19 pneumonia and decrease the high viral load of SARS-CoV-2. It also reduces COVID-19 related hospitalization or death, especially in immunosuppressed patients. Our patient received dexamethasone, remdesivir, tocilizumab, and convalescent plasma as part of conventional COVID-19 treatment with continued worsening of COVID-19 pneumonia. However, the compassionate use of REGEN-COV led to rapid clinical improvement of the patient's symptoms and reduced the SARS-CoV-2 viral load. CONCLUSIONS: Hence, physicians and FDA should consider expanding the use of REGEN-COV mAB therapy to immunosuppressed patients with rapidly worsening COVID-19 pneumonia in adjunct to conventional COVID-19 treatment. Reference #1 Stein D, Oviedo-Orta E, Kampman WA, McGinniss J, Betts G, McDermott M, Holly B, Lancaster JM, Braunstein N, Yancopoulos GD, Weinreich DM. Compassionate Use of REGEN-COV ® in Patients with COVID-19 and Immunodeficiency-Associated Antibody Disorders. Clin Infect Dis. 2021 Dec 31ciab1059. doi 10.1093/cid/ciab1059. Epub ahead of print. PMID 34971385;PMCID PMC8755381. Reference #2 O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Hou P, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM;Covid-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. N Engl J Med. 2021 Sep 23;385(13)1184-1195. doi 10.1056/NEJMoa2109682. Epub 2021 Aug 4. PMID 34347950;PMCI PMC8362593. Reference #3 Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Xiao J, Hooper AT, Hamilton JD, Musser BJ, Rofail D, Hussein M, Im J, Atmodjo DY, Perry C, Pan C, Mahmood A, Hosain R, Davis JD, Turner KC, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Roque-Guerrero L, Acloque G, Aazami H, Cannon K, Simón-Campos JA, Bocchini JA, Kowal B, DiCioccio AT, Soo Y, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD;Trial Investigators. REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. N Engl J Med. 2021 Dec 2;385(23)e81. doi 10.1056/NEJMoa2108163. Epub 2021 Sep 29. PMID 34587383;PMCID PMC8522800. DISCLOSURES No relevant relationships by Mubashir Ayaz Ahmed No relevant relationships by Shayet Hossain Eshan No relevant relationships by Sami Hussein No relevant relationships by Khalid Hussein No relevant relationships by Kamalnath Sankaran Rajagopalan No relevant relationships by Chenyu Sun