Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO) (IPCO)
19 janvier 2021 mis à jour par: University of Erlangen-Nürnberg Medical School
Randomized Controlled Phase 2b Clinical Study in Parallel Groups for the Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma Plus Standard Treatment vs. Standard Treatment Alone of Subjects With Severe COVID-19
This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
The primary objective of the study is the assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19.
The secondary objectives is the Impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection; short-term all-cause mortality; time course of ARDS due to severe COVID-19 and assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma.
As a primary endpoint/variable we will assess change in SOFA score from Baseline Visit to Day 8.
The study design will be prospective, open-label, randomized, controlled and parallel-grouped.
Type d'étude
Interventionnel
Inscription (Anticipé)
58
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Erlangen, Allemagne
- Recrutement
- University Hospital Erlangen
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Contact:
- Carsten Willam, MD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Male or female subject aged ≥18 years.
- Estimated BMI ≥19kg/m² to ≤40kg/m².
- Florid1 SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
- ARDS with Horovitz index <300mmHg.
- Necessity of invasive mechanical ventilation.
- Written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in Germany (
- Subject's assent if obtainable
Exclusion Criteria:
- Previous exposure to COVID-19 convalescent plasma.
- Adverse reaction to plasma proteins in medical history.
- Interval >72h since endotracheal intubation.
- Current or imminent necessity of ECMO treatment.
- Pre-existing COPD GOLD stage 4.
- Chronic congestive heart failure NYHA ≥3.
- Pre-existing left ventricular ejection fraction <30%.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: COVID-19 convalescent plasma
A total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 and standard treatment.
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Infusion of a total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 in Addition to standard treatment.
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Aucune intervention: Standard treatment
Standard treatment.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in SOFA score from Baseline Visit
Délai: [Day 1, Visit 2] to Day 8 [Visit 9]
|
Change in Sequential organ failure assessment (SOFA) score predicts Predicts ICU mortality based on lab results and clinical data.
SOFA includes PaO2, the Glasgow Coma Scale, Mean arterial pressure OR Administration of sedatives, Bilirubin(mg/dl), Creatinine (mg/dl) and platelets.
All values are rated with a value of 1 to 4 (worst condition) and are added up gradually to a final score.
The lower the SOFA score, the better is the prognosis (Maximum value 24)
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[Day 1, Visit 2] to Day 8 [Visit 9]
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection
Délai: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Mean number of days without invasive mechanical ventilation during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject. Time from Baseline Visit [Day 1, Visit 2] to extubation. |
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
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Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality
Délai: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Assessment of mortality during defined time-frame
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Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
|
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Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19
Délai: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Number of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
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Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19
Délai: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Proportion of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
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Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of Oxygen supply in patients with ARDS due to severe COVID-19
Délai: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Mean number of days without supplemental oxygen during the period from Baseline Visit [Day 1, Visit 2] until and including Day 8 [Visit 9], Day 15 [Visit 13], and Day 29 [Visit 15], per treatment group and per subject.
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Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19
Délai: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Mean relative change of PEEP from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
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Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19
Délai: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Mean relative change of FiO2 from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
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Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19
Délai: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Mean relative change of driving pressure from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until stop of invasive mechanical ventilation, whichever comes first.
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Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of invasive mechanical Ventilation in patients with ARDS due to severe COVID-19
Délai: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Time from Baseline Visit [Day 1, Visit 2] to stop of invasive mechanical ventilation.
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Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Carsten Willam, MD, University Hospital Erlangen
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 janvier 2021
Achèvement primaire (Anticipé)
1 septembre 2021
Achèvement de l'étude (Anticipé)
1 septembre 2021
Dates d'inscription aux études
Première soumission
30 décembre 2020
Première soumission répondant aux critères de contrôle qualité
14 janvier 2021
Première publication (Réel)
15 janvier 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 janvier 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 janvier 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UKER-COV2-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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