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

University of Erlangen-Nürnberg Medical School

Status and phase: Unknown; Phase 2

Conditions: Severe COVID-19

Treatments: Biological: COVID-19 convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04712344

UKER-COV2-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

COVID-19 convalescent plasma

Experimental group

Description:

A total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 and standard treatment.

Treatment:

Biological: COVID-19 convalescent plasma

Standard treatment

No Intervention group

Description:

Standard treatment.