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Add-on Reparixin in pazienti adulti con ARDS

8 maggio 2026 aggiornato da: Dompé Farmaceutici S.p.A

Studio di fase 2, randomizzato, in doppio cieco, controllato con placebo, multicentrico per valutare l'efficacia e la sicurezza di Reparixin come terapia aggiuntiva al SoC nella sindrome da distress respiratorio acuto (RESPIRATIO)

Obiettivi dello studio

  1. Caratterizzare l'efficacia di reparixin nel migliorare il danno polmonare e l'infiammazione sistemica e accelerare il recupero clinico e la liberazione dalla ventilazione meccanica in pazienti adulti con ARDS da moderata a grave (rapporto PaO2/FIO2 ≤ 200).
  2. Valutare la sicurezza di reparixin rispetto al placebo nei pazienti arruolati nello studio.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Studio di fase 2, randomizzato, in doppio cieco, controllato con placebo, multicentrico. Tutti i pazienti riceveranno la terapia in linea con l'attuale standard di cura per quanto riguarda la gestione dell'ARDS (la gestione protocollata del ventilatore sarà resa disponibile a tutti i siti in conformità con lo standard di cura attualmente accettato). I pazienti saranno randomizzati (1:1) a reparixin o placebo. La durata del trattamento sarà di 14 giorni.

Lo studio sarà composto da 4 periodi di studio:

Screening, randomizzazione e valutazioni al basale, trattamento (14 giorni con estensione discrezionale fino a 21 giorni), follow-up (fino a 28 giorni o dimissione dall'ospedale, a seconda di quale evento si verifichi per primo, e poi fino al giorno 60).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

66

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  1. Consenso informato firmato, secondo le linee guida e le normative locali.
  2. Adulti maschi e femmine (>18 anni).
  3. Pazienti ventilati meccanicamente (invasivi) con rapporto PaO2/FIO2 ≤200 in presenza di PEEP ≥5 cmH20.
  4. Insufficienza respiratoria non completamente spiegata da insufficienza cardiaca o sovraccarico di liquidi (se l'esacerbazione acuta di insufficienza cardiaca congestizia è identificata come parte del quadro clinico, questo dovrebbe essere affrontato in modo efficace e il prima possibile prima che il paziente possa essere arruolato).
  5. Opacità radiologiche bilaterali compatibili con edema polmonare alla radiografia frontale del torace (CXR) o opacità bilaterali a vetro smerigliato alla tomografia computerizzata (TC) del torace.
  6. ≤48 ore dal soddisfacimento dei criteri ARDS di cui sopra.
  7. ≤7 giorni dal ricovero ospedaliero.

  8. Le donne in età fertile sessualmente attive devono essere disposte a non rimanere incinta entro 30 giorni dall'ultima dose di medicinale sperimentale (IMP) e devono accettare almeno uno dei seguenti metodi affidabili di contraccezione:

    1. Contraccezione ormonale, contraccettivi sistemici, impiantabili, transdermici o iniettabili da almeno 2 mesi prima della visita di screening fino a 30 giorni dopo l'ultima dose IMP;
    2. Un partner sessuale sterile;
    3. Astinenza.

Saranno ammesse partecipanti di sesso femminile in età non fertile o in stato di post-menopausa da almeno 1 anno. Per tutti i soggetti di sesso femminile in età fertile, il risultato del test di gravidanza deve essere negativo prima della prima assunzione del farmaco.

Criteri di esclusione:

  1. Malattia epatica cronica moderata-grave (come verificato da anamnesi rilevante, imaging, se preesistente, e punteggio Child-Pugh B-C).
  2. Disfunzione renale cronica grave: eGFR (MDRD) < 30 ml/min/1,73 m2 o Malattia renale allo stadio terminale in terapia renale sostitutiva.
  3. Partecipazione a un altro studio clinico interventistico.
  4. Pazienti che sono clinicamente determinati ad avere un'alta probabilità di morte entro le prossime 24 ore in base alla stima del PI.
  5. Evidenza di lesione cerebrale anossica
  6. Attualmente riceve ECMO o ventilazione oscillatoria ad alta frequenza.
  7. Estubazione anticipata entro 24 ore dall'arruolamento.
  8. Malignità attiva (ad eccezione dei tumori della pelle non melanotici).
  9. Instabilità emodinamica (aumento >30% dei vasopressori nelle ultime 6 ore o noradrenalina > 0,5 mcg/Kg/min).
  10. Evidenza di dismotilità gastrointestinale (GI), ad esempio dovuta a pancreatite acuta o stato post-operatorio immediato, come dimostrato da distensione gastrica persistente, intollerabilità all'alimentazione enterale e/o residui gastrici persistenti >500 ml).
  11. Dimissione anticipata dall'ospedale o trasferimento in un altro ospedale entro 72 ore dallo screening.
  12. Decisione di sospendere o ritirare il trattamento di sostentamento vitale (i pazienti possono comunque essere idonei se sono impegnati in un supporto completo ad eccezione della rianimazione cardiopolmonare in caso di arresto cardiaco).

  13. Storia di:

    1. Allergia/ipersensibilità documentata a più di un farmaco appartenente alla classe dei sulfamidici, come sulfametazina, sulfametossazolo, sulfasalazina, nimesulide o celecoxib (l'ipersensibilità ai soli antibiotici sulfamidici, ad es. /o dei suoi eccipienti.
    2. Deficit di lattasi, galattosemia o malassorbimento di glucosio-galattosio.
    3. Anamnesi di emorragia o perforazione gastrointestinale dovuta a precedente terapia con farmaci antinfiammatori non steroidei (FANS) o ulcera/emorragia peptica ricorrente.
    4. Ipersensibile all'ibuprofene.
  14. Sanguinamento attivo (escluse le mestruazioni) o diatesi emorragica compresi i pazienti che assumono dosi cronicamente elevate di FANS.
  15. Donne in gravidanza o in allattamento.
  16. Donne in età fertile e uomini fertili che non accettano di utilizzare almeno una forma primaria di contraccezione durante lo studio e fino a 30 giorni dopo l'ultima dose di IMP.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Reparixin + Standard di cura
Reparixin compresse 1200 mg TID (2 compresse x 600 mg TID) in aggiunta allo standard di cura (SoC).
Droga: Reparixina 600 mg
Reparixin 600 mg compresse, somministrate frantumate attraverso un sondino nasogastrico alla dose di 1200 mg TID (2 compresse TID somministrate circa ogni 8 ore circa) come aggiunta alla terapia standard. Dopo l'estubazione e se il paziente è in grado di deglutire, la reparixin può essere somministrata per via orale. Durata totale del trattamento: 14 giorni
Altri nomi:
  • RAPPRESENTANTE
Comparatore placebo: Placebo + Standard di cura
Compresse placebo con la stessa schedula di reparixin, in aggiunta allo standard di cura (SoC)
Altro: Placebo corrispondente

Compresse placebo. Somministrato schiacciato attraverso un sondino nasogastrico con lo stesso programma di reparixin come aggiunta allo standard di cura. Dopo l'estubazione e se il paziente può deglutire, il placebo può essere somministrato per via orale.

Durata totale del trattamento: 14 giorni

Altri nomi:
  • Controllo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Oxygenation Index (OI) From Baseline to Day 7 of Treatment
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Oxygenation Index (OI) From Baseline to Day 4
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dompé Farmaceutici S.p.A

Investigatori

  • Investigatore principale: Moerer Onnen, MD, Universitaetsmedizin Goettingen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 dicembre 2022

Completamento primario (Effettivo)

18 marzo 2025

Completamento dello studio (Effettivo)

18 aprile 2025

Date di iscrizione allo studio

Primo inviato

4 agosto 2022

Primo inviato che soddisfa i criteri di controllo qualità

9 agosto 2022

Primo Inserito (Effettivo)

11 agosto 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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