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Reparixina adicional en pacientes adultos con ARDS

8 de mayo de 2026 actualizado por: Dompé Farmaceutici S.p.A

Estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, multicéntrico para evaluar la eficacia y la seguridad de la reparixina como terapia adicional al SoC en el síndrome de dificultad respiratoria aguda (RESPIRATIO)

Objetivos del estudio

  1. Caracterizar la eficacia de la reparixina para mejorar la lesión pulmonar y la inflamación sistémica y acelerar la recuperación clínica y la liberación de la ventilación mecánica en pacientes adultos con SDRA de moderado a grave (proporción PaO2/FIO2 ≤ 200).
  2. Evaluar la seguridad de reparixina frente a placebo en pacientes incluidos en el estudio.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, multicéntrico. Todos los pacientes recibirán terapia de acuerdo con el estándar de atención actual en lo que respecta al manejo del SDRA (el manejo protocolizado del ventilador estará disponible en todos los sitios de acuerdo con el estándar de atención actualmente aceptado). Los pacientes serán aleatorizados (1:1) para recibir reparixina o placebo. La duración del tratamiento será de 14 días.

El estudio constará de 4 períodos de estudio:

Detección Aleatorización y evaluaciones basales, Tratamiento (14 días con extensión discrecional hasta 21 días), Seguimiento (hasta 28 días o alta hospitalaria, lo que ocurra primero, y luego hasta el día-60).

Tipo de estudio

Intervencionista

Inscripción (Actual)

66

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  1. Consentimiento informado firmado, de acuerdo con las pautas y regulaciones locales.
  2. Adultos masculinos y femeninos (>18 años).
  3. Pacientes ventilados mecánicamente (invasivos) con relación PaO2/FIO2 ≤200 en presencia de PEEP de ≥5 cmH20.
  4. Insuficiencia respiratoria que no se explica completamente por insuficiencia cardíaca o sobrecarga de líquidos (si se identifica una exacerbación de insuficiencia cardíaca congestiva aguda como parte del cuadro clínico, esto debe abordarse de manera efectiva y tan pronto como sea posible antes de que el paciente pueda inscribirse).
  5. Opacidades radiológicas bilaterales consistentes con edema pulmonar en la radiografía de tórax frontal (CXR) u opacidades en vidrio deslustrado bilaterales en una tomografía computarizada (TC) de tórax.
  6. ≤48 horas desde el cumplimiento de los criterios ARDS anteriores.
  7. ≤7 días desde el ingreso hospitalario.

  8. Las mujeres en edad fértil que son sexualmente activas deben estar dispuestas a no quedar embarazadas dentro de los 30 días posteriores a la última dosis del medicamento en investigación (IMP) y deben aceptar al menos uno de los siguientes métodos anticonceptivos confiables:

    1. Anticonceptivos hormonales, anticonceptivos sistémicos, implantables, transdérmicos o inyectables desde al menos 2 meses antes de la visita de selección hasta 30 días después de la última dosis de IMP;
    2. Una pareja sexual estéril;
    3. Abstinencia.

Se admitirán participantes mujeres en edad fértil o en estado posmenopáusico durante al menos 1 año. Para todas las mujeres en edad fértil, el resultado de la prueba de embarazo debe ser negativo antes de la primera ingesta del fármaco.

Criterio de exclusión:

  1. Enfermedad hepática crónica moderada-grave (verificada por antecedentes relevantes, imágenes, si es preexistente, y puntuación Child-Pugh B-C).
  2. Disfunción renal crónica grave: eGFR (MDRD) < 30 ml/min/1,73 m2 o enfermedad renal en etapa terminal en terapia de reemplazo renal.
  3. Participación en otro ensayo clínico intervencionista.
  4. Pacientes que están clínicamente determinados a tener una alta probabilidad de muerte dentro de las próximas 24 horas según la estimación de PI.
  5. Evidencia de lesión cerebral anóxica
  6. Actualmente recibe ECMO o ventilación oscilatoria de alta frecuencia.
  7. Extubación anticipada dentro de las 24 horas posteriores a la inscripción.
  8. Neoplasia maligna activa (a excepción de los cánceres de piel no melanóticos).
  9. Inestabilidad hemodinámica (aumento de vasopresor > 30% en las últimas 6 horas o norepinefrina > 0,5 mcg/Kg/min).
  10. Evidencia de dismotilidad gastrointestinal (GI), por ejemplo, debido a pancreatitis aguda o estado posoperatorio inmediato, como se demuestra por distensión gástrica persistente, intolerancia a la alimentación enteral y/o residuos gástricos persistentes >500 ml).
  11. Alta anticipada del hospital o transferencia a otro hospital dentro de las 72 horas posteriores a la selección.
  12. Decisión de suspender o retirar el tratamiento de soporte vital (los pacientes aún pueden ser elegibles, sin embargo, si están comprometidos con el soporte completo, excepto la reanimación cardiopulmonar si se produce un paro cardíaco).

  13. Historia de:

    1. Alergia/hipersensibilidad documentada a más de un medicamento perteneciente a la clase de sulfonamidas, como sulfametazina, sulfametoxazol, sulfasalazina, nimesulida o celecoxib (la hipersensibilidad a los antibióticos de sulfanilamida solos, p. ej., sulfametoxazol no califica para la exclusión), y al producto del estudio y /o sus excipientes.
    2. Deficiencia de lactasa, galactosemia o malabsorción de glucosa-galactosa.
    3. Antecedentes de hemorragia gastrointestinal o perforación debido a un tratamiento previo con fármacos antiinflamatorios no esteroideos (AINE) o úlcera péptica/hemorragia recurrente.
    4. Hipersensible al ibuprofeno.
  14. Hemorragia activa (excluida la menstruación) o diátesis hemorrágica, incluidas las pacientes que reciben dosis altas crónicas de AINE.
  15. Mujeres embarazadas o lactantes.
  16. Mujeres en edad fértil y hombres fértiles que no acepten usar al menos un método anticonceptivo primario durante el estudio y hasta 30 días después de la última dosis de IMP.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Reparixina + Tratamiento estándar
Comprimidos de reparixina 1200 mg TID (2 comprimidos x 600 mg TID) como complemento al tratamiento estándar (SoC).
Droga: Reparixina 600 mg
Tabletas de Reparixin de 600 mg, administradas trituradas a través de una sonda nasogástrica en una dosis de 1200 mg tres veces al día (2 tabletas tres veces al día administradas aproximadamente cada 8 horas) como complemento al tratamiento estándar. Después de la extubación y si el paciente puede tragar, se puede administrar reparixina por vía oral. Duración total del tratamiento: 14 días
Otros nombres:
  • REPS
Comparador de placebos: Placebo + Estándar de atención
Tabletas de placebo con el mismo programa de reparixina, como complemento al estándar de atención (SoC)
Otro: Placebo coincidente

Tabletas de placebo. Se administra triturado a través de una sonda nasogástrica con el mismo esquema que reparixin como complemento al estándar de atención. Después de la extubación y si el paciente puede tragar se podrá administrar placebo por vía oral.

Duración total del tratamiento: 14 días

Otros nombres:
  • Control

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Oxygenation Index (OI) From Baseline to Day 7 of Treatment
Periodo de tiempo: 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)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Oxygenation Index (OI) From Baseline to Day 4
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Dompé Farmaceutici S.p.A

Investigadores

  • Investigador principal: Moerer Onnen, MD, Universitaetsmedizin Goettingen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de diciembre de 2022

Finalización primaria (Actual)

18 de marzo de 2025

Finalización del estudio (Actual)

18 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

4 de agosto de 2022

Primero enviado que cumplió con los criterios de control de calidad

9 de agosto de 2022

Publicado por primera vez (Actual)

11 de agosto de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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