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All Studies   Meta Analysis    Recent:   

Repeat Subcutaneous Administration of REGEN-COV® in Adults is Well-Tolerated and Prevents the Occurrence of COVID-19

Nov 2021  
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Symp. case 93% Improvement Relative Risk Case 93% Casirivimab/i..  Isa et al.  Prophylaxis  DB RCT Is prophylaxis with casirivimab/imdevimab beneficial for COVID-19? Double-blind RCT 969 patients in the USA (July 2020 - May 2021) Fewer symptomatic cases (p=0.0019) and cases (p=0.0018) c19early.org Isa et al., medRxiv, November 2021 Favorscasirivimab/im.. Favorscontrol 0 0.5 1 1.5 2+
17th treatment shown to reduce risk in March 2021
 
*, now with p = 0.000055 from 29 studies, recognized in 45 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19early.org
RCT 969 patients, 729 treated with monthly subcutaneous casirivimab/imdevimab, showing significantly lower risk of COVID-19 with treatment. There were no grade 3 injection site reactions or hypersensitivity reactions. Slightly more TEAEs were reported with treatment (54.9% vs. 48.3%), due to grade 1-2 ISRs. Serious adverse events were rare and occurred with similar percentages for treatment and control groups. There were no deaths. NCT04519437 (history).
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for many omicron variants1-6.
risk of symptomatic case, 92.6% lower, RR 0.07, p = 0.002, treatment 3 of 729 (0.4%), control 13 of 240 (5.4%), NNT 20, odds ratio converted to relative risk.
risk of case, 92.7% lower, RR 0.07, p = 0.002, treatment 0 of 729 (0.0%), control 10 of 240 (4.2%), NNT 24, 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), seroconversion.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Conflicts of interest: employee of the drug patent holder.
Isa et al., 16 Nov 2021, Double Blind Randomized Controlled Trial, USA, preprint, 31 authors, study period 26 July, 2020 - 21 May, 2021, trial NCT04519437 (history). Contact: flonza.isa@regeneron.com.
This PaperCasirivimab/i..All
Repeat Subcutaneous Administration of REGEN-COV® in Adults is Well-Tolerated and Prevents the Occurrence of COVID-19
MD Flonza Isa, Eduardo Forleo-Neto, Jonathan Meyer, Wenjun Zheng, Scott Rasmussen, Danielle Armas, Masaru Oshita, Cynthia Brinson, Steven Folkerth, Lori Faria, Ingeborg Heirman, Neena Sarkar, Bret J Musser, Shikha Bansal, Meagan P O’brien, Kenneth C Turner, Samit Ganguly, Adnan Mahmood, Ajla Dupljak, Andrea T Hooper, Jennifer D Hamilton, Yunji Kim, Bari Kowal, Yuhwen Soo, Gregory P Geba, Leah Lipsich, Ned Braunstein, George D Yancopoulos, David M Weinreich, Gary A Herman
doi:10.1101/2021.11.10.21265889
Background: Data show that a single dose of casirivimab and imdevimab (REGEN-COV ® ) is effective in treating hospitalized individuals and outpatients with COVID-19 and in post-exposure prophylaxis. We present results from a phase 1, double-blind, placebo-controlled trial evaluating the safety, tolerability, and efficacy of repeat monthly doses of subcutaneous (SC) REGEN-COV in uninfected adult volunteers who were healthy or had chronic stable medical conditions. Methods: Subjects were randomized (3:1) to SC REGEN-COV 1200 mg or placebo dosed every 4 weeks for up to 6 doses. The primary and secondary endpoints evaluated the safety, pharmacokinetics, and immunogenicity of multiple-dose administration of REGEN-COV. Efficacy was evaluated by the incidence of COVID-19 or SARS-CoV-2 seroconversion. Results: In total, 969 subjects were treated. Repeat monthly dosing of SC REGEN-COV led to a 92.4% relative risk reduction in clinically-defined COVID-19 compared to placebo (3/729 [0.4%] vs 13/240 [5.4%]; odds ratio: 0.07 [95% CI, 0.01-0.27]), and a 100% reduction in laboratory-confirmed COVID-19 (0/729 vs 10/240 [4.2%]; odds ratio 0.00). Development of anti-drug antibodies was low (<5% subjects). No grade ≥3 injection-site reactions (ISRs) or hypersensitivity reactions were reported. A slightly higher percentage of subjects reported TEAEs with REGEN-COV (54.9%) than placebo (48.3%), due to ISRs (all grade 1-2). Serious adverse events were rare and occurred at similar percentages in the REGEN-COV and placebo groups. No deaths were reported in the 6-month treatment period.
Notes
References
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We present results from a phase 1, double-blind, ' 'placebo-controlled trial evaluating the safety, tolerability, and efficacy of repeat monthly ' 'doses of subcutaneous (SC) REGEN-COV in uninfected adult volunteers who were healthy or had ' 'chronic stable medical conditions.\n' '\n' '<jats:bold>Methods:</jats:bold> Subjects were randomized (3:1) to SC REGEN-COV 1200 mg or ' 'placebo dosed every 4 weeks for up to 6 doses. The primary and secondary endpoints evaluated ' 'the safety, pharmacokinetics, and immunogenicity of multiple-dose administration of ' 'REGEN-COV. Efficacy was evaluated by the incidence of COVID-19 or SARS-CoV-2 seroconversion.\n' '\n' '<jats:bold>Results:</jats:bold> In total, 969 subjects were treated. Repeat monthly dosing of ' 'SC REGEN-COV led to a 92.4% relative risk reduction in clinically-defined COVID-19 compared ' 'to placebo (3/729 [0.4%] vs 13/240 [5.4%]; odds ratio: 0.07 [95% CI, 0.01–0.27]), and a 100% ' 'reduction in laboratory-confirmed COVID-19 (0/729 vs 10/240 [4.2%]; odds ratio 0.00). ' 'Development of anti-drug antibodies was low (&lt;5% subjects). No grade ≥3 injection-site ' 'reactions (ISRs) or hypersensitivity reactions were reported. A slightly higher percentage of ' 'subjects reported TEAEs with REGEN-COV (54.9%) than placebo (48.3%), due to ISRs (all grade ' '1-2). Serious adverse events were rare and occurred at similar percentages in the REGEN-COV ' 'and placebo groups. 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