Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19
et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiac320 (date from earlier preprint), NCT04426695 (history)
, Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19, The Journal of Infectious Diseases, doi:10.1093/infdis/jiac320 (date from earlier preprint), NCT04426695
RCT 1,336 hospitalized patients with symptom onset <=10 days on low-flow or no supplemental oxygen, showing lower mortality with treatment. Cohorts 2&3 were paused mid-trial due to increased deaths in the treatment arm and these results were not included. NCT04426695 (history).Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, Tatham, VanBlargan].
1.
Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719,
Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2,
https://www.biorxiv.org/content/10.1101/2021.12.14.472719.
2.
Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354,
Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron),
https://www.biorxiv.org/content/10.1101/2021.12.19.473354.
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risk of death, 35.9% lower, RR 0.64, p = 0.02, treatment 59 of 804 (7.3%), control 45 of 393 (11.5%), NNT 24, day 28, mFAS.
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risk of death, 55.6% lower, RR 0.44, p = 0.005, treatment 24 of 360 (6.7%), control 24 of 160 (15.0%), NNT 12, seronegative, day 28, mFAS.
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risk of death, 21.3% lower, RR 0.79, p = 0.42, treatment 26 of 369 (7.0%), control 18 of 201 (9.0%), NNT 52, seropositive, day 28, mFAS.
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risk of death/intubation, 30.9% lower, RR 0.69, p = 0.03, treatment 82 of 804 (10.2%), control 58 of 393 (14.8%), NNT 22, day 1-29, mFAS.
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risk of no hospital discharge, 30.2% lower, RR 0.70, p = 0.02, treatment 90 of 804 (11.2%), control 63 of 393 (16.0%), NNT 21, day 1-29, mFAS.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Conflicts of interest:
research funding from the drug patent holder, employee of the drug patent holder.
Somersan-Karakaya et al., 8 Nov 2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, median age 62.0, 34 authors, study period 10 June, 2020 - 9 April, 2021, average treatment delay 6.0 days, trial NCT04426695 (history).
Abstract: 1
Casirivimab and Imdevimab for the Treatment of Hospitalized
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Patients With COVID-19
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Selin Somersan-Karakaya, MD1,a Eleftherios Mylonakis MD, PhD2,a Vidya P. Menon,
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MD3 Jason C. Wells, MD4 Shazia Ali, PharmD1,b Sumathi Sivapalasingam, MD1,c Yiping
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Sun, PhD1,d Rafia Bhore, PhD1 Jingning Mei, PhD1 Jutta Miller, BS, RN1 Lisa Cupelli,
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PhD1 Eduardo Forleo-Neto, MD1 Andrea T. Hooper, PhD1 Jennifer D. Hamilton, PhD1
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Cynthia Pan, BPharm1 Viet Pham, BS1 Yuming Zhao, MS1 Romana Hosain, MD,
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MPH1,d Adnan Mahmood, MD1 John D. Davis, PhD1 Kenneth C. Turner, PhD1 Yunji
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Kim, PharmD1 Amanda Cook, BS, Dip.Reg.Aff1 Bari Kowal, MS1 Yuhwen Soo, PhD1 A.
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Thomas DiCioccio, PhD1 Gregory P. Geba, MD, Dr.PH1 Neil Stahl, PhD1 Leah Lipsich,
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PhD1,d Ned Braunstein, MD1 Gary A. Herman, MD1 George D. Yancopoulos, MD, PhD1
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and David M. Weinreich, MD1 for the COVID-19 Phase 2/3 Hospitalized Trial Team
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Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, 2Brown University, Providence,
RI, USA, 3NYC Health + Hospitals/Lincoln, The Bronx, NY, USA, 4The Oregon Clinic,
Portland, OR, USA
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© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of
America. This is an Open Access article distributed under the terms of the Creative Commons AttributionNonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits
non-commercial reproduction and distribution of the work, in any medium, provided the original work is
not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please
contact journals.permissions@oup.com
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Therapeutics, Durham, NC, USA.
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BioTherapeutics Inc., New York, NY, USA.
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S. S-K. and E. M. contributed equally.
Former employee of Regeneron Pharmaceuticals, Inc. Current employee of Excision
Former employee of Regeneron Pharmaceuticals, Inc.
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Running title: CAS+IMD in hospitalized patients
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Former employee of Regeneron Pharmaceuticals, Inc. Current employee of Priovant
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Background: The open-label RECOVERY study reported improved survival in
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hospitalized, SARS-CoV-2 seronegative patients treated with casirivimab and
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imdevimab (CAS+IMD).
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Methods: In this phase I/II/III, double-blind, placebo-controlled trial conducted prior to
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widespread circulation of Delta and Omicron, hospitalized COVID-19 patients were
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randomized (1:1:1) to 2.4 g or 8.0 g CAS+IMD or placebo, and characterized at baseline
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for viral load and SARS-CoV-2 serostatus.
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Results: 1336 patients on low-flow or no supplemental (low-flow/no) oxygen were
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treated. The primary endpoint was met: in seronegative patients, the least-squares
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mean difference (CAS+IMD versus placebo) for time-weighted average change from
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baseline in viral load through day 7 was –0.28 log10 copies/mL (95% CI, –0.51 to –0.05;
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P=.0172). The primary clinical analysis of death or mechanical ventilation (death/MV)
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from day 6–29 in patients with high viral load had a strong positive trend but did not
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reach significance...
Late treatment
is less effective
is less effective
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