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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
ProphylaxisRCT · 2,954 patients · multinational · Sep 2021 – Apr 2022
Paxlovid for COVID-19
EPIC-PEP Pfizer Press Release · April 2022 · NCT05047601
Lower severe cases and progression
Not statistically significant · p = 0.42 (severe cases) and p = 0.2 (progression)
PEP RCT showing no significant difference with paxlovid post-exposure prophylaxis. Results from1.
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OutcomeImprovementEffect · pTreatmentControl
risk of hospitalization 66.5% lower · RR 0.33 · p = 1.00 66.5% lowerRR 0.33p = 1.00 0 of 830 (0.0%) 1 of 840 (0.1%) treatment 0 of 830 (0.0%), control 1 of 840 (0.1%)10 day treatmentNNT 840continuity correction due to zero events
risk of hospitalization 66.7% lower · RR 0.33 · p = 0.50 66.7% lowerRR 0.33p = 0.50 0 of 844 (0.0%) 1 of 840 (0.1%) treatment 0 of 844 (0.0%), control 1 of 840 (0.1%)5 day treatmentNNT 840continuity correction due to zero events
risk of severe case 25.2% lower · RR 0.75 · p = 0.42 25.2% lowerRR 0.75p = 0.42 17 of 830 (2.0%) 23 of 840 (2.7%) treatment 17 of 830 (2.0%), control 23 of 840 (2.7%)10 day treatmentNNT 145
risk of severe case 22.1% lower · RR 0.78 · p = 0.43 22.1% lowerRR 0.78p = 0.43 18 of 844 (2.1%) 23 of 840 (2.7%) treatment 18 of 844 (2.1%), control 23 of 840 (2.7%)5 day treatmentNNT 165
medical visit 15.3% lower · RR 0.85 · p = 0.20 15.3% lowerRR 0.85p = 0.20 830 840 treatment 830, control 84010 day treatment
medical visit 3.1% lower · RR 0.97 · p = 0.81 3.1% lowerRR 0.97p = 0.81 844 840 treatment 844, control 8405 day treatment
risk of symptomatic case 35.5% lower · RR 0.65 · p = 0.12 35.5% lowerRR 0.65p = 0.12 830 840 treatment 830, control 84010 day treatment, PCR- at baseline
risk of symptomatic case 29.8% lower · RR 0.70 · p = 0.17 29.8% lowerRR 0.70p = 0.17 844 840 treatment 844, control 8405 day treatment, PCR- at baseline
risk of symptomatic case 4.7% lower · RR 0.95 · p = 0.82 4.7% lowerRR 0.95p = 0.82 887 873 treatment 887, control 87310 day treatment
risk of symptomatic case 27.4% lower · RR 0.73 · p = 0.13 27.4% lowerRR 0.73p = 0.13 889 873 treatment 889, control 8735 day treatment

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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).