Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO) (IPCO)
19 januari 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
58
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Erlangen, Duitsland
- Werving
- University Hospital Erlangen
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Contact:
- Carsten Willam, MD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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%.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: Standard treatment
Standard treatment.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in SOFA score from Baseline Visit
Tijdsspanne: [Day 1, Visit 2] to Day 8 [Visit 9]
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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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Carsten Willam, MD, University Hospital Erlangen
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
18 januari 2021
Primaire voltooiing (Verwacht)
1 september 2021
Studie voltooiing (Verwacht)
1 september 2021
Studieregistratiedata
Eerst ingediend
30 december 2020
Eerst ingediend dat voldeed aan de QC-criteria
14 januari 2021
Eerst geplaatst (Werkelijk)
15 januari 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 januari 2021
Laatste update ingediend die voldeed aan QC-criteria
19 januari 2021
Laatst geverifieerd
1 januari 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UKER-COV2-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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