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0 0.5 1 1.5 2+ Mortality 0% Improvement Relative Risk Severe case 50% primary Hospitalization 57% c19early.com/tc Montgomery et al. NCT04723394 Tixagev../c.. RCT EARLY Favors tixagevimab/ci.. Favors control
Montgomery, 903 patient tixagevimab/cilgavimab early treatment RCT: no change in mortality [p=1], 50% lower severe cases [p=0.01], and 57% lower hospitalization [p=0.002] https://c19p.org/montgomery
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Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial
Montgomery et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00180-1
7 Jun 2022    Source   PDF   Share   Tweet
RCT 910 outpatients in the USA, 456 treated with tixagevimab/cilgavimab, showing significantly lower combined severe COVID-19/death with treatment.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2 [Zhou].
risk of death, 0.2% lower, RR 1.00, p = 1.00, treatment 6 of 452 (1.3%), control 6 of 451 (1.3%), NNT 33975, all cause mortality.
risk of severe case, 50.4% lower, RR 0.50, p = 0.010, treatment 18 of 407 (4.4%), control 37 of 415 (8.9%), NNT 22, primary outcome.
risk of hospitalization, 56.7% lower, RR 0.43, p = 0.002, treatment 17 of 413 (4.1%), control 40 of 421 (9.5%), NNT 19.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Montgomery et al., 6/7/2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, North America, peer-reviewed, mean age 46.0, 20 authors, study period 28 January, 2021 - 22 July, 2021, trial NCT04723394.
Contact: mark.esser@astrazeneca.com.
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