Clinical trial NCT04712344: Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Severe COVID-19
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%.

Primary outcomes:
measure: Change in SOFA score from Baseline Visit
timeFrame: [Day 1, Visit 2] to Day 8 [Visit 9]
Secondary outcomes:
measure: Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection
timeFrame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
measure: Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality
timeFrame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
measure: Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19
timeFrame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
measure: Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19
timeFrame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
measure: Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of Oxygen supply in patients with ARDS due to severe COVID-19
timeFrame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
measure: Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19
timeFrame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
measure: Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19
timeFrame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
measure: Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19
timeFrame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
measure: Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of invasive mechanical Ventilation in patients with ARDS due to severe COVID-19
timeFrame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
Study officials:
affiliation: University Hospital Erlangen
name: Carsten Willam, MD
role: PRINCIPAL_INVESTIGATOR
References: