Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO) (IPCO)
19 januari 2021 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
58
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Erlangen, Tyskland
- Rekrytering
- University Hospital Erlangen
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Kontakt:
- Carsten Willam, MD
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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%.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: Standard treatment
Standard treatment.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in SOFA score from Baseline Visit
Tidsram: [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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Carsten Willam, MD, University Hospital Erlangen
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 januari 2021
Primärt slutförande (Förväntat)
1 september 2021
Avslutad studie (Förväntat)
1 september 2021
Studieregistreringsdatum
Först inskickad
30 december 2020
Först inskickad som uppfyllde QC-kriterierna
14 januari 2021
Första postat (Faktisk)
15 januari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 januari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 januari 2021
Senast verifierad
1 januari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UKER-COV2-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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