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

Severe COVID-19 Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04712344
Study type Interventional
Source University of Erlangen-Nürnberg Medical School
Contact Mario Schiffer, MD
Phone +49913185
Email mario.schiffer@uk-erlangen.de
Status Recruiting
Phase Phase 2
Start date January 18, 2021
Completion date September 2021
View Details
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