Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR)

Pfizer, NCT05011513, EPIC-SR, NCT05011513, Jun 2022
Mortality 67% improvement lower risk ← → higher risk Hospitalization 52% Progression 4% Time to sustained alle.. 8% Change in viral load 4% Paxlovid for COVID-19  EPIC-SR  EARLY TREATMENT RCT Is early treatment with paxlovid beneficial for COVID-19? Double-blind RCT 1,288 patients in multiple countries (Aug 2021 - Jul 2022) Improved viral clearance with paxlovid (p=0.039) c19early.org Pfizer, NCT05011513, June 2022 0 0.5 1 1.5 2+ RR
Results for the terminated and unpublished (until April 2024) EPIC-SR trial.
risk of death, 67.0% lower, RR 0.33, p = 0.49, treatment 0 of 654 (0.0%), control 1 of 634 (0.2%), NNT 634, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 28.
risk of hospitalization, 51.5% lower, RR 0.48, p = 0.20, treatment 5 of 654 (0.8%), control 10 of 634 (1.6%), NNT 123, day 28.
risk of progression, 3.8% lower, RR 0.96, p = 0.21, treatment 494 of 654 (75.5%), control 498 of 634 (78.5%), NNT 33, day 28.
relative time to sustained alleviation, 7.7% lower, relative time 0.92, p = 0.16, treatment mean 12.0 (±13.0) n=654, control mean 13.0 (±12.8) n=634.
relative change in viral load, 3.9% better, RR 0.96, p = 0.04, treatment mean 5.46 (±1.84) n=654, control mean 5.25 (±1.89) n=634, day 14.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Pfizer et al., 14 Jun 2022, Double Blind Randomized Controlled Trial, multiple countries, preprint, 1 author, study period 25 August, 2021 - 25 July, 2022, trial NCT05011513 (history) (EPIC-SR).
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