Status:
UNKNOWN
Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO)
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Severe COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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%.
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04712344
Start Date
January 18 2021
End Date
September 1 2021
Last Update
January 20 2021
Active Locations (1)
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1
University Hospital Erlangen
Erlangen, Germany