A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 24, 2022

Primary Completion Date

July 31, 2022

Study Completion Date

July 31, 2022

Conditions
Pneumonia
Interventions
DRUG

Auxora

All patients will receive 2.0 mg/kg (1.25 mL/kg) of Auxora at 0 hour and 1.6 mg/kg (1 mL/kg) at both 24 hours and 48 hours from the Start of the First Infusion of Auxora (SFIA) at 0 hour over 4 hours. Patients with severe hypoxemic respiratory failure at 48 hours will be randomized 1:1 to receive extended treatment with Auxora 1.6 mg/kg (1 mL/kg) at 72, 96, and 120 hours from the SFIA

DRUG

Placebo

Patients with severe hypoxemic respiratory failure at 48 hours will be randomized 1:1 to receive 1 mL/kg of Placebo at 72, 96, and 120 hours from the SFIA.

Trial Locations (3)

55101

Regions Hospital, Saint Paul

55426

Methodist Hospital, Saint Paul

76104

JPS Health, Fort Worth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CalciMedica, Inc.

INDUSTRY