A Study of Auxora in Patients With Severe COVID-19 Pneumonia

PHASE2CompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

April 8, 2020

Primary Completion Date

June 28, 2021

Study Completion Date

July 30, 2021

Conditions
Pneumonia
Interventions
DRUG

Auxora (Part 1)

Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours.

DRUG

Standard of Care (Part 1)

Patients received standard of care

DRUG

Auxora (Part 2)

Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours.

DRUG

Placebo (Part 2)

Placebo will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Placebo will be administered intravenously (IV) over 4 hours.

Trial Locations (17)

23298

Virginia Commonwealth University, Richmond

48202

Henry Ford Hospital, Detroit

48235

Sinai Grace, Detroit

54311

Aurora Baycare, Green Bay

55101

Regions Hospital, Saint Paul

55426

Methodist Hospital, Saint Louis Park

60611

Northwestern University, Chicago

70809

Baton Rouge General, Baton Rouge

76104

John Peter Smith Hospital, Fort Worth

77030

Houston Methodist Hospital, Houston

79905

Texas Tech University Medical Center, El Paso

80220

National Jewish Health / St. Joseph's Hospital, Denver

90033

University of Southern California / LA County, Los Angeles

90806

Long Beach Memorial, Long Beach

92123

Sharp Memorial San Diego, San Diego

04102

Maine Medical Center, Portland

02115

Brigham and Women's Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CalciMedica, Inc.

INDUSTRY