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

NCT ID: NCT04712344

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2021-09-30

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 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.

Conditions

Severe COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COVID-19 convalescent plasma

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

Group Type: EXPERIMENTAL

COVID-19 convalescent plasma

Intervention Type: BIOLOGICAL

Infusion of a total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 in Addition to standard treatment.

Standard treatment

Standard treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

COVID-19 convalescent plasma

Infusion of a total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 in Addition to standard treatment.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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%.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carsten Willam, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Erlangen

Locations

University Hospital Erlangen

Erlangen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Mario Schiffer, MD

Role: CONTACT

mario.schiffer@uk-erlangen.de

+49913185 ext. 39002

Holger Hackstein, MD

Role: CONTACT

Holger.Hackstein@uk-erlangen.de

+49913185 ext. 42110

Facility Contacts

Carsten Willam, MD

Role: primary

Other Identifiers

UKER-COV2-01

Identifier Type: -

Identifier Source: org_study_id