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All Studies   Meta Analysis   Recent:  
0 0.5 1 1.5 2+ Severe case 75% Improvement Relative Risk Symp. case 42% Symp. case (b) 33% primary Tixagevimab/c..  Levin et al.  Prophylaxis  DB RCT Is prophylaxis with tixagevimab/cilgavimab beneficial for COVID-19? Double-blind RCT 1,121 patients in the USA (December 2020 - March 2021) Lower severe cases (p=0.33) and fewer symptomatic cases (p=0.064), not sig. Levin et al., Clinical Infectious Dise.., Nov 2022 Favors tixagevimab/ci.. Favors control

AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19

Levin et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac899, NCT04625972
Nov 2022  
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1,121 patient PEP RCT showing lower symptomatic cases with tixagevimab/cilgavimab, without statistical significance.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, and BQ.1.1 Planas.
risk of severe case, 75.1% lower, RR 0.25, p = 0.33, treatment 0 of 749 (0.0%), control 1 of 372 (0.3%), NNT 372, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of symptomatic case, 41.7% lower, RR 0.58, p = 0.06, treatment 27 of 749 (3.6%), control 23 of 372 (6.2%), NNT 39, extended data cutoff.
risk of symptomatic case, 32.8% lower, RR 0.67, p = 0.23, treatment 23 of 749 (3.1%), control 17 of 372 (4.6%), NNT 67, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Levin et al., 22 Nov 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, mean age 46.0, 21 authors, study period 2 December, 2020 - 19 March, 2021, trial NCT04625972 (history).
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This PaperTixagev../c..All
AZD7442 (Tixagevimab/Cilgavimab) for Post-Exposure Prophylaxis of Symptomatic Coronavirus Disease 2019
MD Myron J Levin, MD Andrew Ustianowski, MSc Steven Thomas, PhD Alison Templeton, PhD Yuan Yuan, PhD Seth Seegobin, PhD Catherine F Houlihan, MD Ibrahim Menendez-Perez, MBBS Simon Pollett, PhD Rosalinda H Arends, PhD Rohini Beavon, MSc Kanika Dey, MD Pedro Garbes, PhD Elizabeth J Kelly, PhD Gavin C K W Koh, MD Stefan Ivanov, MD Karen A Near, PhD Audrey Sharbaugh, PhD Katie Streicher, PhD Menelas N Pangalos, PhD Mark T Esser
Clinical Infectious Diseases, doi:10.1093/cid/ciac899
Background: We report primary results of a phase 3 trial of AZD7442 (tixagevimab/cilgavimab) for post-exposure prophylaxis to prevent symptomatic coronavirus disease 2019 Methods: Adults without prior SARS-CoV-2 infection or COVID-19 vaccination were enrolled within 8 days of exposure to a SARS-CoV-2-infected individual and randomized 2:1 to a single 300-mg AZD7442 dose (one 1.5-mL intramuscular injection each of tixagevimab and cilgavimab consecutively) or placebo. Primary endpoints were safety and first post-dose SARS-CoV-2 reverse-transcription-polymerase-chain-reaction (RT-PCR)-positive symptomatic COVID-19 event before day 183. Results: 1121 participants were randomized and dosed (mean age 46 years; 49% females; AZD7442, n=749; placebo, n=372). Median (range) follow-up was 49 (5-115) and 48 (20-113) days for AZD7442 and placebo, respectively. Adverse events occurred in 162/749 (21.6%) and 111/372 (29.8%) participants with AZD7442 and placebo, respectively, mostly mild/moderate. RT-PCR-positive symptomatic COVID-19 occurred in 23/749 (3.1%) and 17/372 (4.6%) AZD7442-and placebo-treated participants, respectively (relative risk reduction 33.3%; 95% confidence interval [CI] -25.9 to 64.7; P=.21). In predefined subgroup analyses of 1073 (96%) participants who were SARS-CoV-2 RT-PCR-negative (n=974 [87%]) or missing an RT-PCR result (n=99 [9%]) at baseline, AZD7442 reduced RT-PCR-positive symptomatic COVID-19 by 73.2% (95% CI 27.1 to 90.1) versus placebo. Conclusions: This study did not meet the primary efficacy endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 versus placebo. However, predefined analysis of participants who were SARS-CoV-2 RT-PCR-negative or missing an RT-PCR result at baseline support a role for AZD7442 in preventing symptomatic COVID-19.
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