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

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ClinicalTrials.gov Identifier: NCT04712344
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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Brief Summary:
This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.

Condition or disease Intervention/treatment Phase
Severe COVID-19 Biological: COVID-19 convalescent plasma Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: 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.
No Intervention: Standard treatment
Standard treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Change in SOFA score from Baseline Visit [ Time Frame: [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)


Secondary Outcome Measures :
  1. Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection [ Time Frame: 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.


  2. Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality [ Time Frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] ]
    Assessment of mortality during defined time-frame

  3. Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19 [ Time Frame: 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].

  4. Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19 [ Time Frame: 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].

  5. 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 [ Time Frame: 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.

  6. Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19 [ Time Frame: 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.

  7. Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19 [ Time Frame: 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.

  8. Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19 [ Time Frame: 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.

  9. 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 [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712344


Contacts
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Contact: Mario Schiffer, MD +49913185 ext 39002 mario.schiffer@uk-erlangen.de
Contact: Holger Hackstein, MD +49913185 ext 42110 Holger.Hackstein@uk-erlangen.de

Locations
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Germany
University Hospital Erlangen Recruiting
Erlangen, Germany
Contact: Carsten Willam, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Carsten Willam, MD University Hospital Erlangen
More Information
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT04712344    
Other Study ID Numbers: UKER-COV2-01
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases