Compassionate Use of REGEN-COV® in Patients With Coronavirus Disease 2019 (COVID-19) and Immunodeficiency-Associated Antibody Disorders. (31st December 2021)

• Record Type: Journal Article
• Authors: Stein, David; Oviedo-Orta, Ernesto; Kampman, Wendy A; McGinniss, Jennifer; Betts, George; McDermott, Margaret; Holly, Beth; Lancaster, Johnathan M; Braunstein, Ned; Yancopoulos, George D; Weinreich, David M
• Is Part Of: Clinical infectious diseases. Volume 75:Number 1(2022)
• Page Start: e509
• Page End: e515
• Publication Date: 2021-12-31
• Subjects: antibody deficiency -- B-cell deficiency -- compassionate use -- COVID-19 -- monoclonal antibody; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/ciab1059
• Languages: English
• ISSNs: 1058-4838

Abstract

Abstract: Background: Patients with immunodeficiency-associated antibody disorders are at a higher risk of prolonged/persistent COVID-19 infection, having no viable treatment options. Methods: A retrospective analysis of patients with primary and/or secondary immunodeficiency-associated antibody disorders who received casirivimab and imdevimab (REGEN-COV ® ) under emergency compassionate use. Objective were to describe safety and response to REGEN-COV, focusing on the subset of patients who had COVID-19 duration ≥21 days before treatment. Results: Quantitative (change in oxygenation status and/or viral load) and/or qualitative (physician-reported clinical status) outcomes data are reported from 64 patients. Improvement in ≥1 outcome was observed in 90.6% of the overall patient group. Thirty-seven of these had COVID-19 duration ≥21 days before treatment; median time from diagnosis to REGEN-COV treatment was 60.5 days. Of the 29 patients with COVID-19 duration ≥21 days before treatment and available outcome data, 96.6% showed improvement in ≥1 outcome. In the 14 patients with post-treatment reverse transcription–polymerase chain reaction (RT-PCR) results available, 11 (78.6%) reported a negative RT-PCR following treatment, with 5 (45.5%) and 8 (72.7%) patients reporting a negative RT-PCR within 5 days and 21 days of treatment, respectively. Ten of 85 patients (11.8%) experienced serious adverse events; only one was an infusion-related reaction, possibly related to REGEN-COV. Two deaths were reported; neither were attributed to REGEN-COV. Conclusions: In this retrospective analysis of immunodeficient patients granted REGEN-COV under emergency compassionate use, REGEN-COV treatment was associated with rapid viral clearance and clinical improvement in patients with longstanding COVID-19. Adverse events were consistent with COVID-19 and its associated complications, and due to patients' concurrent medical conditions. Abstract : Patients with immunodeficiency-associated antibody disorders are at a higher risk of prolonged/persistent COVID-19 infection. In this retrospective analysis, compassionate use of REGEN-COV in such patients was associated with rapid viral clearance and/or clinical improvement in the evaluable patients.