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Add-on Reparixin in Adult Patients With ARDS

Primary Purpose

Acute Respiratory Distress Syndrome, Adult

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Reparixin 600mg
Matching Placebo
Sponsored by
Dompé Farmaceutici S.p.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome, Adult focused on measuring ARDS, Reparixin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed Informed Consent, according to local guidelines and regulation.
  2. Male and female adults (>18 years old).
  3. Mechanically ventilated (invasive) patients with PaO2/FIO2 ratio ≤200 in the presence of PEEP of ≥5 cmH20.
  4. Respiratory failure not fully explained by cardiac failure or fluid overload (if acute Congestive Heart Failure exacerbation is identified as part of the clinical picture this should be addressed effectively and as soon as possible before the patient can be enrolled).
  5. Bilateral radiologic opacities consistent with pulmonary edema on the frontal chest x-ray (CXR), or bilateral ground glass opacities on a chest computerized tomography (CT) scan.
  6. ≤48 hours from fulfilling above ARDS criteria.
  7. ≤7 days from hospital admission.
  8. Females of child-bearing potential who are sexually active must be willing not to get pregnant within 30 days after the last Investigational Medicinal Product (IMP) dose and must agree to at least one of the following reliable methods of contraception:

    1. Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives from at least 2 months before the screening visit until 30 days after the last IMP dose;
    2. A sterile sexual partner;
    3. Abstinence.

Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects with child-bearing potential, pregnancy test result must be negative before first drug intake.

Exclusion Criteria:

  1. Moderate-severe chronic hepatic disease (as verified by relevant history, imaging, if pre-existent, and Child-Pugh score B-C).
  2. Severe chronic renal dysfunction: eGFR (MDRD) < 30 mL/min/1.73m2 or End Stage Renal Disease on renal replacement therapy.
  3. Participation in another interventional clinical trial.
  4. Patients that are clinically determined to have a high likelihood of death within the next 24 hours based on PI's estimation.
  5. Evidence of anoxic brain injury
  6. Currently receiving ECMO or high frequency oscillatory ventilation.
  7. Anticipated extubation within 24 hours of enrollment.
  8. Active malignancy (with the exception of non-melanotic skin cancers).
  9. Hemodynamic instability (>30% increase in vasopressor in the last 6 hours or norepinephrine > 0.5 mcg/Kg/min).
  10. Evidence of gastrointestinal (GI) dysmotility e.g., due to acute pancreatitis or immediate post-op state, as demonstrated by persistent gastric distention, enteral feeding intolerability and/or persistent gastric residuals >500 ml).
  11. Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening.
  12. Decision to withhold or withdraw life-sustaining treatment (patients may still be eligible however if they are committed to full support except cardiopulmonary resuscitation if cardiac arrest occurs).
  13. History of:

    1. Documented allergy/hypersensitivity to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g., sulfamethoxazole does not qualify for exclusion), and to the study product and/or its excipients.
    2. Lactase deficiency, galactosemia or glucose-galactose malabsorption.
    3. History of GI bleeding or perforation due to previous Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) therapy or recurrent peptic ulcer/haemorrhage.
    4. Hypersensitive to ibuprofen.
  14. Active bleeding (excluding menses) or bleeding diathesis including patients on chronically high doses of NSAIDs.
  15. Pregnant or lactating women.
  16. Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception during the study and up to 30 days after the last IMP dose.

Sites / Locations

  • The University of Alabama at Birmingham HospitalRecruiting
  • Banner - University Medical Center Phoenix
  • University of Southern California
  • University of California Irvine HealthRecruiting
  • Unversity of California Davis Medical Center
  • Denver HealthRecruiting
  • University of Florida Health Jacksonville
  • Emory Saint Joseph's Hospital
  • Methodist Hospitals of Northwest Indiana
  • Beth Israel Deaconess Medical Center
  • Baystate HealthRecruiting
  • Detroit Medical Center
  • Henry Ford Hospital
  • MyMichigan Medical Center MidlandRecruiting
  • William Beaumont Hospital
  • Jackson Pulmonary AssociatesRecruiting
  • NYU Langone Brooklyn
  • New York University Langone HealthRecruiting
  • The Cleveland Clinic Foundation
  • The Ohio State University Wexner Medical CenterRecruiting
  • University of Oklahoma Medical Center
  • Oregon Health and Science UniversityRecruiting
  • University of Tennessee Medical Center
  • Baptist Hospitals of Southeast TexasRecruiting
  • University of Texas Southwestern Medical Center
  • Houston Methodist Hospital
  • University of Utah Hospitals & Clinics
  • Medical College of Wisconsin
  • Universitaetsklinikum Heidelberg
  • Universitaetsmedizin GoettingenRecruiting
  • Herzzentrum MuensterRecruiting
  • Universitaetsklinikum des Saarlandes
  • Berufsgenossenschaftliche Kliniken BergmannstrostRecruiting
  • Universitaetsklinikum LeipzigRecruiting
  • University Hospital of Schleswig-HolsteinRecruiting
  • Ospedale San RaffaeleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reparixin + Standard of care

Placebo + Standard of care

Arm Description

Reparixin tablets 1200 mg TID (2 tablets x 600 mg TID) as add-on to the standard of care (SoC).

Placebo tablets with the same schedule of reparixin, as add-on to the standard of care (SoC)

Outcomes

Primary Outcome Measures

Change in oxygenation index (OI) from baseline to day 7 of treatment
The OI is defined as: % mean airway pressure x FIO2/PaO2
Ventilator free days (VFD) at day 28
Number of days from successfully weaning to day 28; patients who died before weaning have no ventilator-free days

Secondary Outcome Measures

Change in oxigenation index (OI) from baseline to day 4
The lower the OI the better the outcome
Acute lung injury score [composite of PaO2/FIO2 ratio, PEEP, lung compliance (plateau airway pressure minus PEEP/TV) and extent of pulmonary infiltrates] at 2, 3, 7, 14 days (if still intubated)
Sequential Organ Failure Assessment (SOFA) score at 2, 3, 7, 14 days (if still intubated)
Ventilatory ratio (product of minute ventilation and PaCO2) at 2, 3, 7, 14 days (if still intubated)
Incidence of Extracorporeal Membrane Oxygenation (ECMO) by day 14
Use of vasoactive medications by day 14
Chest X-Rays assessment of pulmonary edema by "radiographic assessment of lung edema" (RALE) score at 2, 3, 7, 14 days
Percentage of patients achieving pressure support ventilation equal to 5 cmH20 with PEEP equal to 5 cmH20 for 2 hours (measure of weaning) by day 28 and at hospital discharge
Intensive Care Unit free days by day 28 and at hospital discharge
Hospital-free days by day 28 and at hospital discharge
Incidence of tracheostomies by day 28 and at hospital discharge
Incidence of transfer to long term acute care (LTAC) facility by day 28 and at hospital discharge
All-cause mortality by day 28
All-cause mortality by day 60
Change from baseline to day 3, 7 and 14 days in plasma levels of IL-6, IL-8, PAI-1, TNFr-1, ICAM-1 RAGE
Plasma levels (free and bound) of DF1681Y (acidic form of reparixin) and relevant metabolites (DF2188Y, DF2243Y, and ibuprofen (DF1674Y))
Plasma levels (free and bound) of DF1681Y (acidic form of reparixin) and relevant metabolites (DF2188Y, DF2243Y, and ibuprofen (DF1674Y)) are measured in a subset of about 24 (10-12 per group) patients selected at pre-defined sites.
Incidence of Treatment Emergent AEs (TEAEs) and SAEs (TESAEs) from the beginning of study treatment to up to the end of study participation.
eGFR, absolute value and change from screening to day 3(±8h), day 7±1, day 14±2, day 21±2 (if still receiving reparixin), day 28±2
Incidence of secondary infections defined as new by day 28±2
Secondary infections defined as new (occurring after the first IMP intake) infection in a previously known to be sterile site, including blood, body fluid or tissue, or new pathogen isolated from cultures of biological samples known to be previously infected by day 28±2

Full Information

First Posted
August 4, 2022
Last Updated
October 4, 2023
Sponsor
Dompé Farmaceutici S.p.A
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1. Study Identification

Unique Protocol Identification Number
NCT05496868
Brief Title
Add-on Reparixin in Adult Patients With ARDS
Official Title
Phase 2, Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Assess Efficacy and Safety of Reparixin as add-on Therapy to SoC in Acute Respiratory Distress Syndrome (RESPIRATIO)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dompé Farmaceutici S.p.A

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study objectives To characterize the efficacy of reparixin in ameliorating lung injury and systemic inflammation and expediting clinical recovery and liberation from mechanical ventilation in adult patients with moderate to severe ARDS (PaO2/FIO2 ratio ≤ 200). To evaluate the safety of reparixin vs. placebo in patients enrolled in the study.
Detailed Description
Phase 2, randomized, double-blinded, placebo controlled, multicenter study. All patients will receive therapy in line with current standard-of-care as it pertains to ARDS management (protocolized ventilator management will be made available to all sites in accordance with currently accepted standard of care). Patients will be randomized (1:1) to either reparixin or placebo. Duration of treatment will be 14 days. The study will consist of 4 study periods: Screening Randomization and Baseline assessments, Treatment (14 days with discretionary extension up to 21 days), Follow-up (up to 28 days or hospital discharge, whichever occurs first, and then up to day-60).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Adult
Keywords
ARDS, Reparixin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
the identity of the treatments will remain unknown to the subject, Investigator, site staff, CRO and Dompé's personnel until the study completion and formal unmasking. Only the Data Monitoring Committee (DMC) will have access to group-unblinded and/or fully unblinded DMC reports.
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reparixin + Standard of care
Arm Type
Experimental
Arm Description
Reparixin tablets 1200 mg TID (2 tablets x 600 mg TID) as add-on to the standard of care (SoC).
Arm Title
Placebo + Standard of care
Arm Type
Placebo Comparator
Arm Description
Placebo tablets with the same schedule of reparixin, as add-on to the standard of care (SoC)
Intervention Type
Drug
Intervention Name(s)
Reparixin 600mg
Other Intervention Name(s)
REP
Intervention Description
Reparixin will be administered through a nasogastric tube at the dose of 1200 mg (2 x 600 mg tablets) TID every 8 hours (6 tablets daily) for 14 days. All patients will receive therapy in line with current standard-of-care as it pertains to ARDS management (protocolized ventilator management will be made available to all sites in accordance with currently accepted standard of care).
Intervention Type
Other
Intervention Name(s)
Matching Placebo
Other Intervention Name(s)
Control
Intervention Description
Placebo will be administered through a nasogastric tube at the dose of 1200 mg (2 x 600 mg tablets) TID every 8 hours (6 tablets daily) for 14 days. All patients will receive therapy in line with current standard-of-care as it pertains to ARDS management (protocolized ventilator management will be made available to all sites in accordance with currently accepted standard of care).
Primary Outcome Measure Information:
Title
Change in oxygenation index (OI) from baseline to day 7 of treatment
Description
The OI is defined as: % mean airway pressure x FIO2/PaO2
Time Frame
to day 7
Title
Ventilator free days (VFD) at day 28
Description
Number of days from successfully weaning to day 28; patients who died before weaning have no ventilator-free days
Time Frame
at day 28
Secondary Outcome Measure Information:
Title
Change in oxigenation index (OI) from baseline to day 4
Description
The lower the OI the better the outcome
Time Frame
to day 4
Title
Acute lung injury score [composite of PaO2/FIO2 ratio, PEEP, lung compliance (plateau airway pressure minus PEEP/TV) and extent of pulmonary infiltrates] at 2, 3, 7, 14 days (if still intubated)
Time Frame
at 2, 3, 7, 14 days
Title
Sequential Organ Failure Assessment (SOFA) score at 2, 3, 7, 14 days (if still intubated)
Time Frame
at 2, 3, 7, 14 days
Title
Ventilatory ratio (product of minute ventilation and PaCO2) at 2, 3, 7, 14 days (if still intubated)
Time Frame
at 2, 3, 7, 14 days
Title
Incidence of Extracorporeal Membrane Oxygenation (ECMO) by day 14
Time Frame
by day 14
Title
Use of vasoactive medications by day 14
Time Frame
by day 14
Title
Chest X-Rays assessment of pulmonary edema by "radiographic assessment of lung edema" (RALE) score at 2, 3, 7, 14 days
Time Frame
at 2, 3, 7, 14 days
Title
Percentage of patients achieving pressure support ventilation equal to 5 cmH20 with PEEP equal to 5 cmH20 for 2 hours (measure of weaning) by day 28 and at hospital discharge
Time Frame
by day 28
Title
Intensive Care Unit free days by day 28 and at hospital discharge
Time Frame
by day 28
Title
Hospital-free days by day 28 and at hospital discharge
Time Frame
by day 28
Title
Incidence of tracheostomies by day 28 and at hospital discharge
Time Frame
by day 28
Title
Incidence of transfer to long term acute care (LTAC) facility by day 28 and at hospital discharge
Time Frame
by day 28
Title
All-cause mortality by day 28
Time Frame
by day 28
Title
All-cause mortality by day 60
Time Frame
by day 60
Title
Change from baseline to day 3, 7 and 14 days in plasma levels of IL-6, IL-8, PAI-1, TNFr-1, ICAM-1 RAGE
Time Frame
to day 3, 7 and 14 day
Title
Plasma levels (free and bound) of DF1681Y (acidic form of reparixin) and relevant metabolites (DF2188Y, DF2243Y, and ibuprofen (DF1674Y))
Description
Plasma levels (free and bound) of DF1681Y (acidic form of reparixin) and relevant metabolites (DF2188Y, DF2243Y, and ibuprofen (DF1674Y)) are measured in a subset of about 24 (10-12 per group) patients selected at pre-defined sites.
Time Frame
day 1, day 2, day 7, day 14
Title
Incidence of Treatment Emergent AEs (TEAEs) and SAEs (TESAEs) from the beginning of study treatment to up to the end of study participation.
Time Frame
from the date of First Patient First Visit (FPFV) to the date of Last Patient Last Visit (LPLV)
Title
eGFR, absolute value and change from screening to day 3(±8h), day 7±1, day 14±2, day 21±2 (if still receiving reparixin), day 28±2
Time Frame
to day 3(±8h), 7±1 day, 14±2 day, 21±2 day, 28±2 day
Title
Incidence of secondary infections defined as new by day 28±2
Description
Secondary infections defined as new (occurring after the first IMP intake) infection in a previously known to be sterile site, including blood, body fluid or tissue, or new pathogen isolated from cultures of biological samples known to be previously infected by day 28±2
Time Frame
by day 28±2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent, according to local guidelines and regulation. Male and female adults (>18 years old). Mechanically ventilated (invasive) patients with PaO2/FIO2 ratio ≤200 in the presence of PEEP of ≥5 cmH20. Respiratory failure not fully explained by cardiac failure or fluid overload (if acute Congestive Heart Failure exacerbation is identified as part of the clinical picture this should be addressed effectively and as soon as possible before the patient can be enrolled). Bilateral radiologic opacities consistent with pulmonary edema on the frontal chest x-ray (CXR), or bilateral ground glass opacities on a chest computerized tomography (CT) scan. ≤48 hours from fulfilling above ARDS criteria. ≤7 days from hospital admission. Females of child-bearing potential who are sexually active must be willing not to get pregnant within 30 days after the last Investigational Medicinal Product (IMP) dose and must agree to at least one of the following reliable methods of contraception: Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives from at least 2 months before the screening visit until 30 days after the last IMP dose; A sterile sexual partner; Abstinence. Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects with child-bearing potential, pregnancy test result must be negative before first drug intake. Exclusion Criteria: Moderate-severe chronic hepatic disease (as verified by relevant history, imaging, if pre-existent, and Child-Pugh score B-C). Severe chronic renal dysfunction: eGFR (MDRD) < 30 mL/min/1.73m2 or End Stage Renal Disease on renal replacement therapy. Participation in another interventional clinical trial. Patients that are clinically determined to have a high likelihood of death within the next 24 hours based on PI's estimation. Evidence of anoxic brain injury Currently receiving ECMO or high frequency oscillatory ventilation. Anticipated extubation within 24 hours of enrollment. Active malignancy (with the exception of non-melanotic skin cancers). Hemodynamic instability (>30% increase in vasopressor in the last 6 hours or norepinephrine > 0.5 mcg/Kg/min). Evidence of gastrointestinal (GI) dysmotility e.g., due to acute pancreatitis or immediate post-op state, as demonstrated by persistent gastric distention, enteral feeding intolerability and/or persistent gastric residuals >500 ml). Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening. Decision to withhold or withdraw life-sustaining treatment (patients may still be eligible however if they are committed to full support except cardiopulmonary resuscitation if cardiac arrest occurs). History of: Documented allergy/hypersensitivity to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g., sulfamethoxazole does not qualify for exclusion), and to the study product and/or its excipients. Lactase deficiency, galactosemia or glucose-galactose malabsorption. History of GI bleeding or perforation due to previous Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) therapy or recurrent peptic ulcer/haemorrhage. Hypersensitive to ibuprofen. Active bleeding (excluding menses) or bleeding diathesis including patients on chronically high doses of NSAIDs. Pregnant or lactating women. Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception during the study and up to 30 days after the last IMP dose.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria De Pizzol, BSc-PhD
Phone
+3902583831
Email
clinops@pec.dompe.it
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Conz, M.Sc
Phone
+3902583831
Email
clinops@pec.dompe.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico Minnella, MD
Organizational Affiliation
Dompè farmaceutici SpA
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Morris, MD
Facility Name
Banner - University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esa Rayyan, MD
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Huerta, MD
Facility Name
University of California Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timmy Cheng, MD
Facility Name
Unversity of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Albertson, MD
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivor Douglass, MD
Facility Name
University of Florida Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi Mirsaeidi, MD
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ishan Metha, MD
Facility Name
Methodist Hospitals of Northwest Indiana
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olu Apata, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alon Dagan, MD
Facility Name
Baystate Health
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Tidswell, MD
Facility Name
Detroit Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wael Saasouh, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Ouellette, MD
Facility Name
MyMichigan Medical Center Midland
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Blamoun, MD
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Girish Nair, MD
Facility Name
Jackson Pulmonary Associates
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Rappai, MD
Facility Name
NYU Langone Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Zacharioudakis, MD
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kaufman, MD
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Gama De Abreu, MD
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonal Pannu, MD
Facility Name
University of Oklahoma Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Abdo, MD
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akram Khan, MD
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isaac Biney, MD
Facility Name
Baptist Hospitals of Southeast Texas
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Iribarren, MD
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8894
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Choi, MD
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faisal Masud, MD
Facility Name
University of Utah Hospitals & Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle Harris, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahul Nanchal, MD
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten Brenner, MD
Facility Name
Universitaetsmedizin Goettingen
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moerer Onnen, MD
Facility Name
Herzzentrum Muenster
City
Muenster
State/Province
Nordrhein Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Zarbock, MD
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Lepper, MD
Facility Name
Berufsgenossenschaftliche Kliniken Bergmannstrost
City
Halle
State/Province
Sachsen Anhalt
ZIP/Postal Code
6112
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann Wrigge, MD
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
4103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Theresa Voelker, MD
Facility Name
University Hospital of Schleswig-Holstein
City
Kiel
State/Province
Schleswig Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Schaedler, MD
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Landoni, MD

12. IPD Sharing Statement

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Add-on Reparixin in Adult Patients With ARDS

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