Recombinant C1 inhibitor in the prevention of severe COVID-19: a randomized, open-label, multi-center phase IIa trial.

ABSTRACT:

Background

Conestat alfa (ConA), a recombinant human C1 inhibitor, may prevent thromboinflammation.

Methods

We conducted a randomized, open-label, multi-national clinical trial in which hospitalized adults at risk for progression to severe COVID-19 were assigned in a 2:1 ratio to receive either 3 days of ConA plus standard of care (SOC) or SOC alone. Primary and secondary endpoints were day 7 disease severity on the WHO Ordinal Scale, time to clinical improvement within 14 days, and safety, respectively.

Results

The trial was prematurely terminated because of futility after randomization of 84 patients, 56 in the ConA and 28 in the control arm. At baseline, higher WHO Ordinal Scale scores were more frequently observed in the ConA than in the control arm. On day 7, no

SUBMITTER: Urwyler P 

PROVIDER: S-EPMC10641758 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature