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@CovidAnalysis
All Studies   All Outcomes       

Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)

Ngumah et al., NCT04439071, FITE19, NCT04439071
Jun 2023  
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Mortality, day 60 -132% Improvement Relative Risk Mortality, day 28 -55% Ventilation -47% Emvododstat  FITE19  LATE TREATMENT  DB RCT Is late treatment with emvododstat beneficial for COVID-19? Double-blind RCT 189 patients in multiple countries Higher mortality (p=0.16) and ventilation (p=0.31), not sig. c19early.org Ngumah et al., NCT04439071, June 2023 Favorsemvododstat Favorscontrol 0 0.5 1 1.5 2+
RCT 189 hospitalized patients showing higher mortality with emvododstat (PTC299), without statistical significance.
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risk of death, 132.3% higher, RR 2.32, p = 0.16, treatment 9 of 92 (9.8%), control 4 of 95 (4.2%), day 60.
risk of death, 54.9% higher, RR 1.55, p = 0.53, treatment 6 of 92 (6.5%), control 4 of 95 (4.2%), day 28.
risk of mechanical ventilation, 47.0% higher, RR 1.47, p = 0.31, treatment 16 of 94 (17.0%), control 11 of 95 (11.6%), day 28.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ngumah et al., 26 Jun 2023, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, preprint, 1 author, trial NCT04439071 (history) (FITE19). Contact: medinfo@ptcbio.com.
This PaperEmvododstatAll
Late treatment
is less effective
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