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

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Severe COVID-19

• 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