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Compassionate Use of REGEN-COV(R) in Patients with COVID-19 and Immunodeficiency-Associated Antibody Disorders
David Stein; Ernesto Oviedo-Orta; Wendy A. Kampman; Jennifer McGinniss; George Betts; Margaret McDermott; Beth Holly; Johnathan M. Lancaster; Ned Braunstein; George D. Yancopoulos; David M. Weinreich.
Afiliação
  • David Stein; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • Ernesto Oviedo-Orta; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • Wendy A. Kampman; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • Jennifer McGinniss; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • George Betts; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • Margaret McDermott; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • Beth Holly; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • Johnathan M. Lancaster; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • Ned Braunstein; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • George D. Yancopoulos; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
  • David M. Weinreich; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
Preprint em Inglês | medRxiv | ID: ppmedrxiv-21265911
Artigo de periódico
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ABSTRACT
BackgroundPatients with immunodeficiency-associated antibody disorders are at a higher risk of prolonged/persistent COVID-19 infection, having no viable treatment options. MethodsThis is a retrospective analysis of patients with primary and/or secondary immunodeficiency-associated antibody disorders who received casirivimab and imdevimab (REGEN-COV(R)) under emergency compassionate use. The objectives were to describe safety and response to REGEN-COV, with a focus on the subset of patients who had COVID-19 duration [≥]21 days prior to treatment. Quantitative (change in oxygenation status and/or viral load) and/or qualitative (physician-reported clinical status) patient outcomes data are reported. ResultsOutcome data are available from 64 patients who received REGEN-COV. Improvement in [≥]1 outcome measure was observed in 90.6% of the overall patient group. Thirty-seven of these patients had COVID-19 duration [≥]21 days prior to treatment, with a median time from RT-PCR diagnosis to REGEN-COV administration of 60.5 days. Of the 29 patients with COVID-19 duration [≥]21 days prior to treatment who had available outcome data, 96.6% showed improvement in [≥]1 outcome measure evaluated following use of REGEN-COV. In the 14 patients who had post-treatment RT-PCR results available, 11 (78.6%) reported a negative RT-PCR following treatment with REGEN-COV, with 5 patients (45.5%) reporting a negative RT-PCR within 5 days of treatment and 8 (72.7%) reporting a negative RT-PCR within 21 days of treatment. ConclusionsIn this retrospective analysis of immunodeficient patients who were granted REGEN-COV under the compassionate use program, REGEN-COV treatment was associated with rapid viral clearance and clinical improvement in the evaluable patients with long-standing COVID-19. SummaryPatients 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.
Licença
cc_by_nc_nd
Texto completo: Disponível Coleções: Preprints Base de dados: medRxiv Tipo de estudo: Experimental_studies / Estudo observacional / Estudo prognóstico / Pesquisa qualitativa Idioma: Inglês Ano de publicação: 2021 Tipo de documento: Preprint
Texto completo: Disponível Coleções: Preprints Base de dados: medRxiv Tipo de estudo: Experimental_studies / Estudo observacional / Estudo prognóstico / Pesquisa qualitativa Idioma: Inglês Ano de publicação: 2021 Tipo de documento: Preprint
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