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Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVID™ for Post-Exposure Prophylactic Use

Pfizer, Press Release, EPIC-PEP, NCT05047601
Apr 2022  
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Hospitalization, 10 day 67% Improvement Relative Risk Hospitalization, 5 day 67% Severe case, 10 day 25% Severe case, 5 day 22% Medical visit, 10 day 15% Medical visit, 5 day 3% Symp. case, 10 day, PCR- 36% Symp. case, 5 day, PCR- 30% Symp. case, 10 day 5% Symp. case, 5 day 27% Paxlovid  EPIC-PEP  Prophylaxis  DB RCT Is prophylaxis with paxlovid beneficial for COVID-19? Double-blind RCT 2,954 patients in multiple countries (Sep 2021 - Apr 2022) Lower severe cases (p=0.42) and progression (p=0.2), not sig. c19early.org Pfizer, Press Release, April 2022 Favorspaxlovid Favorscontrol 0 0.5 1 1.5 2+
PEP RCT showing no significant difference with paxlovid post-exposure prophylaxis. Results from1.
risk of hospitalization, 66.5% lower, RR 0.33, p = 1.00, treatment 0 of 830 (0.0%), control 1 of 840 (0.1%), NNT 840, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 10 day treatment.
risk of hospitalization, 66.7% lower, RR 0.33, p = 0.50, treatment 0 of 844 (0.0%), control 1 of 840 (0.1%), NNT 840, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 5 day treatment.
risk of severe case, 25.2% lower, RR 0.75, p = 0.42, treatment 17 of 830 (2.0%), control 23 of 840 (2.7%), NNT 145, 10 day treatment.
risk of severe case, 22.1% lower, RR 0.78, p = 0.43, treatment 18 of 844 (2.1%), control 23 of 840 (2.7%), NNT 165, 5 day treatment.
medical visit, 15.3% lower, RR 0.85, p = 0.20, treatment 830, control 840, 10 day treatment.
medical visit, 3.1% lower, RR 0.97, p = 0.81, treatment 844, control 840, 5 day treatment.
risk of symptomatic case, 35.5% lower, RR 0.65, p = 0.12, treatment 830, control 840, 10 day treatment, PCR- at baseline.
risk of symptomatic case, 29.8% lower, RR 0.70, p = 0.17, treatment 844, control 840, 5 day treatment, PCR- at baseline.
risk of symptomatic case, 4.7% lower, RR 0.95, p = 0.82, treatment 887, control 873, 10 day treatment.
risk of symptomatic case, 27.4% lower, RR 0.73, p = 0.13, treatment 889, control 873, 5 day treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Pfizer et al., 29 Apr 2022, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, preprint, 1 author, study period 9 September, 2021 - 12 April, 2022, trial NCT05047601 (history) (EPIC-PEP).
This PaperPaxlovidAll
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