Ignite Creation Date:
2024-05-06 @ 2:32 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04345614
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2020-04-07
Brief Title:
A Study of Auxora in Patients With Severe COVID-19 Pneumonia
Sponsor:
CalciMedica Inc
Organization:
CalciMedica Inc
Study Overview
Official Title:
A Randomized Double Blind Placebo-Controlled Study of Auxora for the Treatment of Severe COVID-19 Pneumonia CARDEA
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Part 1 of this trial enrolled 30 patients to receive Auxora formerly CM4620 in a 21 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 PaO2FiO2 200 randomized into the study will be capped at 26 320 patients with a PaO2FiO2 200 will be enrolled Patients with an estimated PaO2FiO2 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 20 mgkg 125 mLkg administered at 0 hour and then 16 mgkg 1 mLkg at 24 hours and 16 mgkg 1 mLkg at 48 hours from the SFISD The dose of placebo will be 125 mLkg administered at 0 hour and then 1 mLkg at 24 hours and 1 mLkg 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 PaO2FiO2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None