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Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO) | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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

NCT04712344•University of Erlangen-Nürnberg Medical School

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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%.

Locations (1)

University Hospital Erlangen

Erlangen, Germany

Key Dates

Start Date

January 18, 2021

Primary Completion Date

September 1, 2021

Completion Date

September 1, 2021

Last Updated

January 20, 2021

Enrollment

ESTIMATED participants

Conditions

Severe COVID-19

Interventions

COVID-19 convalescent plasma

BIOLOGICAL

Contacts

Mario Schiffer, MD

CONTACT

+49913185 mario.schiffer@uk-erlangen.de

Holger Hackstein, MD

CONTACT

+49913185 Holger.Hackstein@uk-erlangen.de

Risk Identification of Long-term Complications

NCT06235866

Severe COVID-19

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TERMINATEDPHASE3

Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia

NCT05254990

Infectious PneumoniaSevere COVID-19

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AVAILABLE

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Risk Identification of Long-term Complications

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