Add-on Reparixin in Adult Patients With ARDS

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

December 6, 2022

Primary Completion Date

March 18, 2025

Study Completion Date

April 18, 2025

Conditions
Acute Respiratory Distress Syndrome, Adult
Interventions
DRUG

Reparixin 600mg

Reparixin 600 mg tablets, administered crushed through nasogastric tube at the dose of 1200 mg TID (2 tablets TID administered approximately about every 8 hours) as add-on to the standard of care. After extubation and if the patient can swallow, reparixin may be administered orally. Total duration of the treatment: 14 days

OTHER

Matching Placebo

"Placebo tablets. Administered crushed through nasogastric tube with the same schedule as reparixin as add-on to the standard of care. After extubation and if the patient can swallow placebo may be administered orally.~Total duration of the treatment: 14 days"

Trial Locations (40)

4103

Universitaetsklinikum Leipzig, Leipzig

6112

Berufsgenossenschaftliche Kliniken Bergmannstrost, Halle

10016

New York University Langone Health, New York

11220

NYU Langone Brooklyn, Brooklyn

20132

Ospedale San Raffaele, Milan

23298

Virginia Commonwealth University Health System, Richmond

24105

University Hospital of Schleswig-Holstein, Kiel

30342

Emory Saint Joseph's Hospital, Atlanta

33606

University of South Florida, Tampa

35233

The University of Alabama at Birmingham Hospital, Birmingham

37075

Universitaetsmedizin Goettingen, Göttingen

37920

University of Tennessee Medical Center, Knoxville

39202

Jackson Pulmonary Associates, Jackson

43210

The Ohio State University Wexner Medical Center, Columbus

44195

The Cleveland Clinic Foundation, Cleveland

46404

Methodist Hospitals of Northwest Indiana, Gary

48073

William Beaumont Hospital, Royal Oak

48149

Herzzentrum Muenster, Münster

48201

Detroit Medical Center, Detroit

48202

Henry Ford Hospital, Detroit

48670

MyMichigan Medical Center Midland, Midland

53226

Medical College of Wisconsin, Milwaukee

65212

University of Missouri Health Care, Columbia

69120

Universitaetsklinikum Heidelberg, Heidelberg

73104

University of Oklahoma Medical Center, Oklahoma City

75020

Cardiovoyage, Denison

77030

Houston Methodist Hospital, Houston

77701

Baptist Hospitals of Southeast Texas, Beaumont

80204

Denver Health, Denver

84108

University of Utah Hospitals & Clinics, Salt Lake City

85006

Banner - University Medical Center Phoenix, Phoenix

90033

University of Southern California, Los Angeles

92868

University of California Irvine Health, Orange

95817

Unversity of California Davis Medical Center, Sacramento

97239

Oregon Health and Science University, Portland

02215

Beth Israel Deaconess Medical Center, Boston

02462-1607

Newton Wellesley Hospital, Newton

01107

Baystate Health, Springfield

07601

Hackensack Meridian Health, Hackensack

75390-8894

University of Texas Southwestern Medical Center, Dallas

All Listed Sponsors
lead

Dompé Farmaceutici S.p.A

INDUSTRY