REGEN-COV antibody cocktail (casirivimab/imdevimab) for the treatment of inpatients with early hospital-acquired COVID-19: a single center experience
Faraone et al.,
REGEN-COV antibody cocktail (casirivimab/imdevimab) for the treatment of inpatients with early..,
Research Square, doi:10.21203/rs.3.rs-1170976/v1 (Preprint)
Retrospective 34 patients with hospital-acquired COVID-19, showing lower mortality and oxygen requirements with early casirivimab/imdevimab treatment.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, Tatham, VanBlargan].
risk of death, 92.2% lower, RR 0.08, p = 0.03, treatment 0 of 11 (0.0%), control 8 of 23 (34.8%), NNT 2.9, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of oxygen therapy, 94.5% lower, RR 0.06, p = 0.02, treatment 0 of 11 (0.0%), control 15 of 23 (65.2%), NNT 1.5, odds ratio converted to relative risk, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Faraone et al., 5 May 2022, retrospective, Italy, preprint, 12 authors, study period 25 October, 2020 - 30 April, 2021, average treatment delay 2.3 days.
Contact:
antfaraone@gmail.com.
Abstract: REGEN-COV antibody cocktail
(casirivimab/imdevimab) for the treatment of
inpatients with early hospital-acquired COVID-19: a
single center experience
Antonio Faraone ( antfaraone@gmail.com )
Ospedale San Giovanni di Dio https://orcid.org/0000-0001-6095-8403
Francesca Fabbrizzi
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Tommaso Picchioni
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Elena Lovicu
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Lorenzo Tofani
Department of Statistics, Computer Science, Applications, University of Florence, Florence
Giulia Scocchera
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Aldo Lo Forte
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Andrea Crociani
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Paolo Carrai
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Serena Sbaragli
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Michael Bettucchi
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Alberto Fortini
Department of Internal Medicine, San Giovanni di Dio Hospital, Florence
Research Article
Keywords: casirivimab/imdevimab, COVID-19, hospital-acquired, inpatient, monoclonal antibody, REGENCOV.
Page 1/17
Posted Date: May 5th, 2022
DOI: https://doi.org/10.21203/rs.3.rs-1170976/v1
License: This work is licensed under a Creative Commons Attribution 4.0 International License.
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Abstract
Inpatients with hospital-acquired (HA) COVID-19 have mortality rates above 30%. Subjects with early
diagnosis of COVID-19 and risk factors for disease progression are suitable for treatment with anti-SARSCoV-2 neutralizing monoclonal antibodies (mAbs). We retrospectively assessed the outcome of a cohort
of hospitalized patients with laboratory confirmed SARS-CoV-2 nosocomial infection who were admitted
to the COVID-19 general ward of an acute-care Italian hospital between October 25, 2020 and April 30,
2021. Patients receiving the REGEN-COV mAb cocktail (casirivimab/imdevimab) were compared with
those receiving standard care.
Of 34 patients, 11 (mean age, 73.1; 9 males) underwent treatment with REGEN-COV and 23 received
standard care. The 2 study groups were well balanced regarding age, sex, comorbidities, acute illness
severity at diagnosis of SARS-CoV-2 infection, and all participants had at least 2 risk factors for disease
progression. Five of 11 patients in the REGEN-COV group and 16 of 23 in the standard care group were
asymptomatic at diagnosis; the remaining had symptoms of mild COVID-19. All patients received REGENCOV within 3 days of infection confirmation. Treatment with REGEN-COV was inversely associated with
oxygen requirement for COVID-19 during hospital stay (OR 0.02, CI 0–0.52, p=0.0174). No 28-day deaths
were registered in the REGEN-COV group, compared to 8 (34.8%) in the standard care group (p=0.0339).
Kaplan-Meier analysis confirmed the survival advantage of REGEN-COV group (log-rank p=0.00324). No
serious adverse events related to REGEN-COV administration were recorded.
Based on these findings, REGEN-COV appears safe and might prevent disease progression in high-risk
inpatients with early diagnosis of HA-COVID-19.
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