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Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO) (IPCO)

19. januar 2021 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

58

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Tyskland
      • Erlangen, Tyskland
        • Rekruttering
        • University Hospital Erlangen
        • Kontakt:
          • Carsten Willam, MD

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

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female subject aged ≥18 years.
  2. Estimated BMI ≥19kg/m² to ≤40kg/m².
  3. Florid1 SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
  4. ARDS with Horovitz index <300mmHg.
  5. Necessity of invasive mechanical ventilation.
  6. Written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in Germany (
  7. Subject's assent if obtainable

Exclusion Criteria:

  1. Previous exposure to COVID-19 convalescent plasma.
  2. Adverse reaction to plasma proteins in medical history.
  3. Interval >72h since endotracheal intubation.
  4. Current or imminent necessity of ECMO treatment.
  5. Pre-existing COPD GOLD stage 4.
  6. Chronic congestive heart failure NYHA ≥3.
  7. Pre-existing left ventricular ejection fraction <30%.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: COVID-19 convalescent plasma
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.
Ingen indgriben: Standard treatment
Standard treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in SOFA score from Baseline Visit
Tidsramme: [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)
[Day 1, Visit 2] to Day 8 [Visit 9]

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection
Tidsramme: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]

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]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality
Tidsramme: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of mortality during defined time-frame
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19
Tidsramme: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Number of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19
Tidsramme: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Proportion of subjects without supplemental oxygen on Day 8 [Visit 9], on Day 15 [Visit 13], and on Day 29 [Visit 15].
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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
Tidsramme: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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.
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19
Tidsramme: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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.
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19
Tidsramme: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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.
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19
Tidsramme: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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.
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
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
Tidsramme: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Time from Baseline Visit [Day 1, Visit 2] to stop of invasive mechanical ventilation.
Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]

Samarbejdspartnere og efterforskere

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

Sponsor

University of Erlangen-Nürnberg Medical School

Efterforskere

  • Ledende efterforsker: Carsten Willam, MD, University Hospital Erlangen

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)

18. januar 2021

Primær færdiggørelse (Forventet)

1. september 2021

Studieafslutning (Forventet)

1. september 2021

Datoer for studieregistrering

Først indsendt

30. december 2020

Først indsendt, der opfyldte QC-kriterier

14. januar 2021

Først opslået (Faktiske)

15. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UKER-COV2-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Kliniske forsøg med Alvorlig COVID-19

Kliniske forsøg med COVID-19 convalescent plasma

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