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0 0.5 1 1.5 2+ Mortality 36% Improvement Relative Risk Mortality (b) 56% Mortality (c) 21% Death/intubation 31% Discharge 30% Casirivimab/i..  Somersan-Karakaya et al.  LATE TREATMENT  DB RCT Is late treatment with casirivimab/imdevimab beneficial for COVID-19? Double-blind RCT 1,197 patients in multiple countries (Jun 2020 - Apr 2021) Lower mortality (p=0.021) and death/intubation (p=0.027) Somersan-Karakaya et al., The J. Infec.., Nov 2021 Favors casirivimab/im.. Favors control

Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19

Somersan-Karakaya et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiac320 (date from preprint), NCT04426695
Nov 2021  
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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.
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.
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.
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.
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.
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.
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).
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Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19
MD Selin Somersan-Karakaya, MD Eleftherios Mylonakis, MD Vidya P Menon, MD Jason C Wells, PharmD Shazia Ali, MD Sumathi Sivapalasingam, PhD Yiping Sun, PhD Rafia Bhore, PhD Jingning Mei, BS, RN Jutta Miller, PhD Lisa Cupelli, MD Eduardo Forleo-Neto, PhD Andrea T Hooper, PhD Jennifer D Hamilton, Cynthia Pan, BS Viet Pham, MS Yuming Zhao, MD, MPH Romana Hosain, MD Adnan Mahmood, PhD John D Davis, PhD Kenneth C Turner, PharmD Yunji Kim, BS, Dip.Reg Amanda Cook, Aff, MS Bari Kowal, PhD Yuhwen Soo, PhD A Thomas Dicioccio, MD Gregory P Geba, Dr Ph, PhD Neil Stahl, PhD Leah Lipsich, MD Ned Braunstein, MD Gary A Herman, MD, PhD George D Yancopoulos, MD David M Weinreich
Background: The open-label RECOVERY study reported improved survival in hospitalized, SARS-CoV-2 seronegative patients treated with casirivimab and imdevimab (CAS+IMD). Methods: In this phase I/II/III, double-blind, placebo-controlled trial conducted prior to widespread circulation of Delta and Omicron, hospitalized COVID-19 patients were randomized (1:1:1) to 2.4 g or 8.0 g CAS+IMD or placebo, and characterized at baseline for viral load and SARS-CoV-2 serostatus. Results: 1336 patients on low-flow or no supplemental (low-flow/no) oxygen were treated. The primary endpoint was met: in seronegative patients, the least-squares mean difference (CAS+IMD versus placebo) for time-weighted average change from baseline in viral load through day 7 was -0.28 log 10 copies/mL (95% CI, -0.51 to -0.05; P=.0172). The primary clinical analysis of death or mechanical ventilation (death/MV) from day 6-29 in patients with high viral load had a strong positive trend but did not reach significance. CAS+IMD numerically reduced all-cause mortality in seronegative patients through day 29 (relative risk reduction, 55.6%; 95% CI, 24.2-74.0). No safety concerns were noted. Conclusions: In hospitalized COVID-19 patients on low-flow/no oxygen, CAS+IMD reduced viral load and likely improves clinical outcomes in the overall population, with the benefit driven by seronegative patients, and no harm observed in seropositive patients.
Notes Forest plot shows relative risk and relative risk reduction with 95% CIs for CAS+IMD combined dose analysis (2.4 g and 8.0 g) versus placebo. Parameters examined include death within 28 days, discharge alive from hospital from days 1 to 29, and death or mechanical ventilation from days 1 to 29. For all populations, the mFAS was comprised of patients who tested positive for SARS-CoV-2 at baseline. Populations analyzed include patients who tested negative for all SARS-CoV-2 antibodies at baseline (seronegative mFAS), patients who tested positive for any SARS-CoV-2 antibody at baseline (seropositive mFAS), those with borderline, inconclusive or missing baseline serology (other), and the overall population regardless of serostatus (overall mFAS). For the proportion of death within 28 days and the proportion of death or mechanical ventilation with 28 days, the lower bounds of the CI of the relative risk reduction were -342.0% and -241.0%, respectively, which are presented as "NA" in the figure . Abbreviations: CAS+IMD, casirivimab and imdevimab; CI, confidence interval; mFAS, modified full analysis set; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
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Late treatment
is less effective
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