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

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. Objectives 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) patient outcomes data are reported from 64 patients who received REGEN-COV. 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 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 RT-PCR results available, 11 (78.6%) reported a negative RT-PCR following treatment, with 5 (45.5%) reporting a negative RT-PCR within 5 days and 8 (72.7%) within 21 days of treatment. 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 the compassionate use program, REGEN-COV treatment was associated with rapid viral clearance and clinical improvement in patients with long-standing COVID-19. Adverse events were consistent with COVID-19 and its associated complications, and due to patients’ concurrent medical conditions.

Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial

“…Supportive evidence of CAS + IMD efficacy in patients with B-cell deficiency and dysfunction was previously reported. 26 Additionally, regarding the seroconversion data presented in this analysis, we recognise that anti-nucleocapsid IgG response wanes, and that some participants who were infected might not have developed an antibody response. To compensate, we collected serology samples at multiple timepoints during the study to capture even a transient anti-nucleocapsid IgG response.…”

Omicron Variant Escapes Therapeutic Monoclonal Antibodies (mAbs) Including Recently Released Evusheld®, Contrary to 8 Prior Main Variant of Concern (VOC)

“…To the Editor —In their recent article, Stein et al reported efficiency of REGN-CoV-2 ® in patients with long-standing coronavirus disease 2019 (COVID-19), allowing rapid viral clearance and clinical improvement [ 1 ]. This therapy, using monoclonal antibodies (mAbs) targeting the receptor-binding domain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, is also currently used for active immunization of COVID-19 in immunocompromised patients that do not respond to a complete vaccine schedule.…”

Real-life data on monoclonal antibodies and antiviral drugs in Italian inborn errors of immunity patients during COVID-19 pandemic

“…As far as we are aware, only few data are available regarding the same treatments in patients with secondary immunodeficiencies, mainly focusing on severe COVID-19 and hospitalized patients. In the available studies, SARS-CoV-2 specific treatments were often late administered during the disease course ( 51 , 53 ). Moreover, available series and studies generally group patients according to the cause of secondary immunodeficiencies (e.g.…”