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

Ngumah et al., NCT04439071, FITE19, NCT04439071, Jun 2023

Outcome

Improvement

Relative Risk · 95% CI

Mortality, day 60

-132%2.32 · 0.74–7.28

00.511.52+

← Emvododstat
reduces riskEmvododstat
increases risk →

Higher mortality and ventilation

Not statistically significant · p = 0.16 (mortality) and p = 0.31 (ventilation)

.hsva .va--anim-stagger :is(.va__row,.plot__row,.va__verdict){opacity:1}.hsva .va--anim .plot__shade{opacity:var(--shade-opacity)}.hsva .va--anim-stagger .ci{transform:translateY(-50%)}.hsva .va--anim-stagger .pt{transform:none}.hsva .va--anim-settle .pt{left:calc(min(var(--pt), 2) / 2 * 100%)}.hsva .va--anim-settle .ci{left:calc(var(--lo) / 2 * 100%);width:calc((var(--hi) - var(--lo)) / 2 * 100%)}

RCT 189 hospitalized patients showing higher mortality with emvododstat (PTC299), without statistical significance.

Important missing comments or errors? Let us know.

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.

Late treatment
is less effective