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All Studies   Meta Analysis    Recent:   

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

Levin et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac899 (date from FDA disclosure of results), STORM CHASER, NCT04625972
Dec 2021  
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0 0.5 1 1.5 2+ Symp. case 42% Improvement Relative Risk Symp. case (b) 33% primary Tixagevimab/c..  STORM CHASER  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) Fewer symptomatic cases with tixagevimab/cilgavimab (not stat. sig., p=0.064) c19early.org Levin et al., Clinical Infectious Dise.., Dec 2021 Favors tixagevimab/ci.. Favors control
38th treatment shown to reduce risk in May 2022
 
*, now known with p = 0.000029 from 17 studies, recognized in 31 countries. Efficacy is variant dependent.
Lower risk for mortality, hospitalization, and cases.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
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, BQ.1.11, BA.5, BA.2.75, XBB2, ХВВ.1.9.1, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.13.
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., 8 Dec 2021, 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) (STORM CHASER). Contact: mark.esser@astrazeneca.com.
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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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.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>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). 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