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Add-on Reparixin til voksne patienter med ARDS

8. maj 2026 opdateret af: Dompé Farmaceutici S.p.A

Fase 2, randomiseret, dobbeltblindet, placebokontrolleret, multicenterundersøgelse for at vurdere effektiviteten og sikkerheden af ​​Reparixin som tilføjelsesterapi til SoC ved akut respiratorisk distress-syndrom (RESPIRATIO)

Studiemål

  1. At karakterisere effektiviteten af ​​reparixin til at lindre lungeskade og systemisk inflammation og fremskynde klinisk genopretning og frigørelse fra mekanisk ventilation hos voksne patienter med moderat til svær ARDS (PaO2/FIO2-forhold ≤ 200).
  2. For at evaluere sikkerheden af ​​reparixin vs. placebo hos patienter, der er inkluderet i undersøgelsen.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fase 2, randomiseret, dobbeltblindet, placebokontrolleret, multicenterundersøgelse. Alle patienter vil modtage terapi i overensstemmelse med den nuværende plejestandard, hvad angår ARDS-styring (protokolliseret respiratorstyring vil blive gjort tilgængelig for alle steder i overensstemmelse med aktuelt accepteret plejestandard). Patienterne vil blive randomiseret (1:1) til enten reparixin eller placebo. Behandlingsvarighed vil være 14 dage.

Studiet vil bestå af 4 studieperioder:

Screening Randomisering og baseline vurderinger, Behandling (14 dage med skønsmæssig forlængelse op til 21 dage), Opfølgning (op til 28 dage eller hospitalsudskrivning, alt efter hvad der indtræffer først, og derefter op til dag-60).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

66

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • The University of Alabama at Birmingham Hospital
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Banner - University Medical Center Phoenix
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • University of Southern California
      • Orange, California, Forenede Stater, 92868
        • University of California Irvine Health
      • Sacramento, California, Forenede Stater, 95817
        • Unversity of California Davis Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80204
        • Denver Health
    • Florida
      • Tampa, Florida, Forenede Stater, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Emory Saint Joseph's Hospital
    • Indiana
      • Gary, Indiana, Forenede Stater, 46404
        • Methodist Hospitals of Northwest Indiana
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Newton, Massachusetts, Forenede Stater, 02462-1607
        • Newton Wellesley Hospital
      • Springfield, Massachusetts, Forenede Stater, 01107
        • Baystate Health
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48201
        • Detroit Medical Center
      • Midland, Michigan, Forenede Stater, 48670
        • MyMichigan Medical Center Midland
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
        • Jackson Pulmonary Associates
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65212
        • University of Missouri Health Care
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack Meridian Health
    • New York
      • Brooklyn, New York, Forenede Stater, 11220
        • NYU Langone Brooklyn
      • New York, New York, Forenede Stater, 10016
        • New York University Langone Health
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University Wexner Medical CEnter
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Medical Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • University of Tennessee Medical Center
    • Texas
      • Beaumont, Texas, Forenede Stater, 77701
        • Baptist Hospitals of Southeast Texas
      • Dallas, Texas, Forenede Stater, 75390-8894
        • University of Texas Southwestern Medical Center
      • Denison, Texas, Forenede Stater, 75020
        • Cardiovoyage
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84108
        • University of Utah Hospitals & Clinics
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University Health System
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
  • Italien
    • Lombardy
      • Milan, Lombardy, Italien, 20132
        • Ospedale San Raffaele
  • Tyskland
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Tyskland, 69120
        • Universitaetsklinikum Heidelberg
    • Lower Saxony
      • Göttingen, Lower Saxony, Tyskland, 37075
        • Universitaetsmedizin Goettingen
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Tyskland, 48149
        • Herzzentrum Muenster
    • Saxony
      • Leipzig, Saxony, Tyskland, 4103
        • Universitaetsklinikum Leipzig
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Tyskland, 6112
        • Berufsgenossenschaftliche Kliniken Bergmannstrost
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Tyskland, 24105
        • University Hospital of Schleswig-Holstein

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Underskrevet informeret samtykke i henhold til lokale retningslinjer og regler.
  2. Mandlige og kvindelige voksne (>18 år).
  3. Mekanisk ventilerede (invasive) patienter med PaO2/FIO2-forhold ≤200 i nærvær af PEEP på ≥5 cmH20.
  4. Åndedrætssvigt ikke fuldt ud forklaret af hjertesvigt eller væskeoverbelastning (hvis akut kongestiv hjertesvigt-eksacerbation identificeres som en del af det kliniske billede, bør dette behandles effektivt og så hurtigt som muligt, før patienten kan indskrives).
  5. Bilaterale radiologiske opaciteter, der stemmer overens med lungeødem på frontal thorax røntgen (CXR), eller bilaterale slebet glasopaciteter på en thorax computertomografi (CT) scanning.
  6. ≤48 timer fra opfyldelse af ovenstående ARDS-kriterier.
  7. ≤7 dage fra hospitalsindlæggelse.

  8. Kvinder i den fødedygtige alder, som er seksuelt aktive, skal være villige til ikke at blive gravide inden for 30 dage efter den sidste dosis af Investigational Medicinal Product (IMP) og skal acceptere mindst én af følgende pålidelige præventionsmetoder:

    1. Hormonel prævention, systemiske, implanterbare, transdermale eller injicerbare præventionsmidler fra mindst 2 måneder før screeningsbesøget indtil 30 dage efter den sidste IMP-dosis;
    2. En steril seksuel partner;
    3. Afholdenhed.

Kvindelige deltagere med ikke-fertil alder eller i postmenopausal status i mindst 1 år vil blive optaget. For alle kvindelige forsøgspersoner med den fødedygtige alder skal graviditetstesten være negativ før første lægemiddelindtagelse.

Ekskluderingskriterier:

  1. Moderat-alvorlig kronisk leversygdom (som verificeret af relevant historie, billeddiagnostik, hvis den allerede eksisterer, og Child-Pugh-score B-C).
  2. Alvorlig kronisk nyreinsufficiens: eGFR (MDRD) < 30 ml/min/1,73 m2 eller slutstadie nyresygdom på nyreudskiftningsterapi.
  3. Deltagelse i et andet interventionelt klinisk forsøg.
  4. Patienter, der er klinisk bestemt til at have en høj sandsynlighed for død inden for de næste 24 timer baseret på PI's estimering.
  5. Bevis på anoxisk hjerneskade
  6. Modtager i øjeblikket ECMO eller højfrekvent oscillerende ventilation.
  7. Forventet ekstubation inden for 24 timer efter tilmelding.
  8. Aktiv malignitet (med undtagelse af ikke-melanotiske hudkræftformer).
  9. Hæmodynamisk ustabilitet (>30 % stigning i vasopressor inden for de sidste 6 timer eller noradrenalin > 0,5 mcg/Kg/min).
  10. Beviser for gastrointestinal (GI) dysmotilitet, fx på grund af akut pancreatitis eller umiddelbar post-operation, som påvist ved vedvarende gastrisk udspilning, enteral næring intolerabilitet og/eller vedvarende gastriske rester >500 ml).
  11. Forventet udskrivning fra hospitalet eller overførsel til et andet hospital inden for 72 timer efter screening.
  12. Beslutning om at tilbageholde eller afbryde livsopretholdende behandling (patienter kan dog stadig være berettigede, hvis de er forpligtet til fuld støtte, undtagen hjerte-lunge-redning, hvis der opstår hjertestop).

  13. Historien om:

    1. Dokumenteret allergi/overfølsomhed over for mere end én medicin, der tilhører klassen af ​​sulfonamider, såsom sulfamethazin, sulfamethoxazol, sulfasalazin, nimesulid eller celecoxib (overfølsomhed over for sulfanilamidantibiotika alene, f.eks. sulfamethoxazol-produktet kvalificerer ikke til undersøgelsen og kvalificerer ikke til undersøgelsen) /eller dets hjælpestoffer.
    2. Lactase-mangel, galaktosæmi eller glucose-galactose malabsorption.
    3. Anamnese med GI-blødning eller perforation på grund af tidligere behandling med ikke-steroide antiinflammatoriske lægemidler (NSAID'er) eller tilbagevendende mavesår/blødning.
    4. Overfølsom over for ibuprofen.
  14. Aktiv blødning (eksklusive menstruation) eller blødende diatese inklusive patienter på kronisk høje doser af NSAID'er.
  15. Gravide eller ammende kvinder.
  16. Kvinder i den fødedygtige alder og fertile mænd, som ikke accepterer at bruge mindst én primær form for prævention under undersøgelsen og op til 30 dage efter den sidste IMP-dosis.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Reparixin + Standard for pleje
Reparixin tabletter 1200 mg TID (2 tabletter x 600 mg TID) som tilføjelse til standardbehandlingen (SoC).
Medicin: Reparixin 600mg
Reparixin 600 mg tabletter, administreret knust gennem nasogastrisk sonde i en dosis på 1200 mg TID (2 tabletter TID administreret ca. hver 8. time) som tilføjelse til standardbehandlingen. Efter ekstubation og hvis patienten kan synke, kan reparixin indgives oralt. Samlet behandlingsvarighed: 14 dage
Andre navne:
  • REP
Placebo komparator: Placebo + plejestandard
Placebotabletter med samme skema for reparixin som tilføjelse til standardbehandlingen (SoC)
Andet: Matchende placebo

Placebo tabletter. Indgivet knust gennem nasogastrisk sonde med samme tidsplan som reparixin som tilføjelse til standardbehandlingen. Efter ekstubation, og hvis patienten kan synke, kan placebo indgives oralt.

Samlet behandlingsvarighed: 14 dage

Andre navne:
  • Styring

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Oxygenation Index (OI) From Baseline to Day 7 of Treatment
Tidsramme: Baseline to Day 7
Oxygenation Index is defined as Mean Airway Pressure multiplied by (Fraction of Inspired Oxygen[FiO2]) x (100)/(Partial Pressure of Oxygen[PaO2]). It is a measure of efficiency of oxygen utilization in the body, with lower values indicating better oxygenation. OI values can range from 0 to 1000, with values below 25 generally associated with more favorable clinical outcomes. OI at Day 7 was derived according to estimand definition. If a participant died before or at Day 7 and OI was missing, an unfavorable value was imputed. If a participant was extubated at Day 7 and OI was not evaluable, a favorable value was imputed. In all other cases, OI at Day 7 was considered missing. Baseline was defined as last measurement collected prior to investigational medicinal product intake. Change from baseline was defined as post-baseline assessment minus baseline value. Adjusted means and 95% confidence interval from an ANOVA model with multiple imputation (MI) for missing data have been presented.
Baseline to Day 7
Ventilator-Free Days (VFD)
Tidsramme: At Day 28
Ventilator free days (VFDs) through Day 28 were defined as the number of days from the first IMP intake during which the participant was alive and free of invasive mechanical ventilation. Participants who died before or at Day 28 were assigned a value of 0 ventilator-free days, in accordance with the estimand definition. Adjusted means and 95% confidence interval from an ANOVA model with MI for missing data have been presented.
At Day 28

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Oxygenation Index (OI) From Baseline to Day 4
Tidsramme: Baseline to Day 4
Oxygenation Index (OI) is defined as Mean Airway Pressure multiplied by (FiO2) x (100) / (PaO2). It is a measure of the efficiency of oxygen utilization in the body, with lower values indicating better oxygenation. OI values can range from 0 to 1000, with values below 25 generally associated with more favorable clinical outcomes. OI at Day 7 was derived according to the estimand definition. If a participant died before or at Day 7 and OI was missing, an unfavorable value was imputed. If a participant was extubated at Day 7 and OI was not evaluable, a favorable value was imputed. In all other cases, OI at Day 7 was considered missing. For Day 4, no imputation or adjusted means were applied; only observed data from participants with available measurements were used. Baseline was defined as the last measurement collected prior to IMP intake. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline to Day 4
Change From Baseline of Acute Lung Injury (ALI) Score
Tidsramme: Baseline and at Days 2, 3, 7 and 14
Acute Lung Injury (ALI) Score is a composite 4-point scoring system validated by the National Heart, Lung, and Blood Institute (NHLBI) acute respiratory distress syndrome (ARDS) Network that considers PaO2/FiO2, the level of positive end-expiratory pressure (PEEP), lung/respiratory compliance [plateau airway pressure minus PEEP/Tidal Volume (TV)], and the extent of pulmonary infiltrates on the chest radiograph. Each criterion was scored from 0-4 based on the severity of the condition. The final score was calculated by dividing the total score by the number of criteria used. A score of 0 indicates no lung injury, a score between 0.1 to 2.5 indicates mild to moderate lung injury and a score of >2.5 indicates severe lung injury (ARDS). Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline and at Days 2, 3, 7 and 14
Change From Baseline of Sequential Organ Failure Assessment (SOFA) Score
Tidsramme: Baseline and at Days 2, 3, 7 and 14
The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score based on the degree of dysfunction of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems). The score ranges for each system organ classes range from 0 to 4. SOFA score was calculated every 24 hours using (for each organ system) the worst variable recorded within the same 24 hours. The best possible score corresponds to 0 whereas the worst score corresponds to 24. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline and at Days 2, 3, 7 and 14
Change From Baseline of Ventilatory Ratio
Tidsramme: Baseline and at Days 2, 3, 7 and 14

The Ventilatory Ratio (VR) is a simple, non-invasive bedside index used to monitor the efficiency of carbon dioxide (CO2) clearance in mechanically ventilated participants, particularly those with ARDS.

VR = [minute ventilation (ml/min) × PaCO2 (mm Hg)] / [predicted body weight × 100 (ml/min) × 37.5 (mm Hg)] VR is a unitless ratio, and a value approximating 1 would represent normal ventilating lungs. An elevated value of VR would represent either increased pulmonary dead space, increased VCO2 or both. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline and at Days 2, 3, 7 and 14
Number of Participants Requiring Extracorporeal Membrane Oxygenation (ECMO) at Day 14
Tidsramme: At Day 14
Extracorporeal Membrane Oxygenation (ECMO) is an advanced form of temporary life support used for participants with life-threatening heart or lung failure that has not responded to conventional treatments. It functions as a modified heart-lung bypass machine, circulating blood outside the body to add oxygen and remove carbon dioxide before returning it to the participants. Use of ECMO between first investigational medicinal product intake and Day 14 was counted.
At Day 14
Percentage of Participants Using Vasoactive Medications at Day 14
Tidsramme: At Day 14
Use of vasoactive medication is defined as the percentage of participants who received ≥1 vasoactive medication at any time from first IMP intake (Day 1) up to and including Day 14 (inclusive window), divided by the number of participants in the analysis population. Use of Vasoactive Medications is collected in "Ventilation - Specific Information" CRF Daily assessments through extubation. An event is recorded as "Yes" if vasoactive medication use is reported at any daily assessment performed between the date/time of first IMP intake (Day 1) and Day 14 (Day 1 + 13 days), inclusive. If no use is reported during this period, the event is recorded as "No" provided the last available assessment occurs on or after Day 12 (allowing a ±2-day window for the Day 14 visit). The event is recorded as missing if the last available assessment occurs before Day 12.
At Day 14
Change From Baseline of Chest X-ray (CXR) Assessment of Pulmonary Edema by Radiographic Assessment of Lung Edema (RALE) Score
Tidsramme: Baseline and at Days 2, 3, 7 and 14
Radiographic Assessment of Lung Edema (RALE) score is a validated, semi-quantitative tool for quantifying pulmonary edema and ARDS severity using chest X-rays (CXR). It is calculated by dividing the lung fields on the chest radiograph into four quadrants. Each quadrant was assigned a number, and the extent of alveolar opacities (the consolidation score, from 0 to 4) and density of alveolar opacities (the density score, from 1 to 3) was determined. If the consolidation score was 0, the density score was 0. The final RALE score was the sum of the product of the consolidation and density score for each quadrant. Thus, the final RALE score ranged from minimum 0 to maximum 48. Higher RALE scores indicate more severe edema and poorer outcomes. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline and at Days 2, 3, 7 and 14
Percentage of Participants Achieving Pressure Support Ventilation Equal to 5 cm H20 With PEEP Equal to 5 cm H20 for 2 Hours (Measure of Weaning)
Tidsramme: At Day 28 and Hospital Discharge (Up to Day 30)
Continuous Positive Airway Pressure (CPAP) is defined as use of pressure support ventilation equal to 5 cmH2O with PEEP equal to 5 cmH2O for 2 hours. Each qualifying CPAP trial recorded in the Ventilation Specific Information CRF is counted as one weaning attempt. By Day 28: An event is recorded as "Yes" if at least one CPAP weaning attempt (>0) is reported between Day 1 (first IMP intake) and Day 28 (Day 1 + 27 days). The event is "No" if all available assessments during this period are present and equal to 0; otherwise, the event is missing. By Hospital Discharge: An event is recorded as "Yes" if at least one CPAP weaning attempt (>0) is reported between Day 1 and hospital discharge. The event is "No" if all available assessments during this period are present and equal to 0; otherwise, the event is missing. Hospital discharge date is obtained from EOS or, if missing, from the Hospital Discharge visit date; if unavailable, hospitalization is assumed ongoing.
At Day 28 and Hospital Discharge (Up to Day 30)
Intensive Care Unit (ICU)-Free Days
Tidsramme: At Day 28 and Hospital Discharge (Up to Day 30)
Intensive Care Unit (ICU) free days were defined as number of calendar days from first IMP intake during which a participant was alive and not hospitalized in an ICU. ICU-free days at Day 28 were calculated as 28 minus total number of ICU days up to Day 28, with negative values set to 0. Participants who died on or before Day 28 were assigned 0 ICU-free days. If a participant was discharged before Day 28 and died after discharge but before Day 28, ICU-free days at Day 28 equaled ICU-free days at discharge. Endpoint was set to missing if participant was alive but followed for fewer than 26 days or if required data were missing. ICU-free days at hospital discharge were calculated as (discharge date - first IMP intake date + 1) minus total ICU days up to discharge, with negative values set to 0. Participants who died during hospitalization were assigned 0 ICU-free days. If discharge did not occur and death occurred after Day 28, ICU-free days at discharge equaled ICU-free days at Day 28.
At Day 28 and Hospital Discharge (Up to Day 30)
Hospital-free Days
Tidsramme: Up to Day 28
Hospital-free days are a participant-centered metric defining the number of days a participant stays alive outside an acute-care hospital. If the participant was alive at Day 28 (last available day ≥26), hospital-free days were calculated as 28 minus total hospital days up to Day 28. If the participant died on or before Day 28, hospital-free days were set to 0.
Up to Day 28
Percentage of Participants With Tracheostomies
Tidsramme: At Day 28 and Hospital Discharge (Up to Day 30)
Percentage of participants who underwent a tracheostomy between Day 1 and Day 28 or hospital discharge, has been presented. The event is recorded as "Yes" if a tracheostomy occurred during this period, "No" if no procedure occurred and the visit/discharge date is available and missing if both the procedure date and visit/discharge date are unavailable.
At Day 28 and Hospital Discharge (Up to Day 30)
Percentage of Participants Transferred to a Long-Term Acute Care (LTAC) Facility
Tidsramme: From Day 1 of first IMP intake through Day 28 and Hospital Discharge (Up to Day 30)
An LTAC is a Long Term Acute Care Hospital, a facility that specializes in the treatment of participants with serious medical conditions, including patients with ongoing needs for mechanical ventilation, but who no longer require intensive care or extensive diagnostic procedures. The participants in LTAC are transferred there directly from the intensive care unit because they require more care than they can receive in a rehabilitation center, skilled care facility or at home.
From Day 1 of first IMP intake through Day 28 and Hospital Discharge (Up to Day 30)
Percentage of Participants Who Died by Day 28 and Day 60
Tidsramme: Up to Day 28 and 60
Percentage of death by Day 28 and Day 60 has been reported. The event is recorded as "Yes" if death occurred within the period, "No" if the participant was alive with last available assessment at or beyond Day 28 or Day 60.
Up to Day 28 and 60
Hospital Discharge by Day 28
Tidsramme: Day 28
A participant was considered discharged alive by Day 28 if hospital discharge occurred on or before Day 28, regardless of vital status after discharge. Participants were considered not discharged alive by Day 28 if they died without a recorded discharge date, were discharged after Day 28, had a missing discharge date with sufficient follow-up (last available day ≥26), or had a discharge date equal to the date of death. The endpoint was set to missing if the discharge date was missing and the participant was alive but followed for fewer than 26 days. Percentage of participants discharged from hospital by Day 28 has been presented.
Day 28
Change From Baseline in Plasma Biomarkers: Interleukin-6 (IL-6), IL-8, and Plasma Tumor Necrosis Factor Receptor 1 (TNFr-1)
Tidsramme: Baseline and at Days 3, 7 and 14
Plasma biomarker levels for Interleukin -6 (IL-6), IL-8 and plasma Tumor Necrosis Factor Receptor 1 (TNFr-1) were measured using validated laboratory methods. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was calculated as the post-baseline plasma concentration minus the baseline concentration.
Baseline and at Days 3, 7 and 14
Change From Baseline in Plasma Biomarkers: PAI-1, ICAM-1, and RAGE
Tidsramme: Baseline and at Days 3, 7 and 14
Plasma biomarker levels of plasminogen activator inhibitor-1 (PAI-1), intercellular adhesion molecule-1 (ICAM-1), and receptor for advanced glycation end products (RAGE) were measured using validated laboratory methods. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was calculated as the post-baseline plasma concentration minus the baseline concentration.
Baseline and at Days 3, 7 and 14
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (Serious TEAEs)
Tidsramme: Up to 26 Months
An Adverse Event (AE) is any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention. A TEAE is defined as any untoward medical occurrence that begins or worsens in intensity or frequency after the initiation of a treatment (e.g., drug, device, or procedure) in a clinical study. A Serious TEAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization.
Up to 26 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dompé Farmaceutici S.p.A

Efterforskere

  • Ledende efterforsker: Moerer Onnen, MD, Universitaetsmedizin Goettingen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. december 2022

Primær færdiggørelse (Faktiske)

18. marts 2025

Studieafslutning (Faktiske)

18. april 2025

Datoer for studieregistrering

Først indsendt

4. august 2022

Først indsendt, der opfyldte QC-kriterier

9. august 2022

Først opslået (Faktiske)

11. august 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REP0122
  • 2022-001612-25 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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