A Study of Auxora in Patients With Severe COVID-19 Pneumonia
Status:
Completed
Trial end date:
2021-07-30
Target enrollment:
Participant gender:
Summary
Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1
randomized, open label trial of patients with severe and critical COVID-19 pneumonia. Part 2
will consist of a randomized, double blind, placebo-controlled (RCT) study that will evaluate
efficacy, safety, and the pharmacokinetic profile of Auxora in patients with severe COVID-19
pneumonia. The number of patients with an imputed PaO2/FiO2 >200 randomized into the study
will be capped at 26. 320 patients with a PaO2/FiO2 ≤200 will be enrolled. Patients with an
estimated PaO2/FiO2 of 75-200 will be stratified to ensure balanced randomization between the
Auxora and placebo arms. Subgroup analyses will be performed to explore how time to recovery
is influenced by baseline variables and to evaluate the treatment effect at different levels
of each of these variables. The dose of Auxora will be 2.0 mg/kg (1.25 mL/kg) administered at
0 hour, and then 1.6 mg/kg (1 mL/kg) at 24 hours and 1.6 mg/kg (1 mL/kg) at 48 hours from the
SFISD. The dose of placebo will be 1.25 mL/kg administered at 0 hour and then 1 mL/kg at 24
hours and 1 mL/kg at 48 hours from the SFISD. Remdesivir, corticosteroids and convalescent
plasma will be allowed. The infusion of Auxora will start within 12 hours from the time the
patient or LAR provides informed consent. Efficacy analyses will be presented by treatment
group (Auxora vs Placebo) based on the Efficacy Analysis Set of the imputed PaO2/FiO2 ≤200
subgroup, except where it is specified otherwise. The statistical analysis approach will be
designed to assess the significance of the primary and first secondary endpoint using the
Benjamini and Hochberg method to control the overall trial level alpha level.