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

NCT04712344 | Unknown Phase 2 DMC

• 1 other identifier: UKER-COV2-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Severe COVID-19

Outcome Measures

Primary Outcomes (1)

• Change in SOFA score from Baseline Visit

  Change in Sequential organ failure assessment (SOFA) score predicts Predicts ICU mortality based on lab results and clinical data. SOFA includes PaO2, the Glasgow Coma Scale, Mean arterial pressure OR Administration of sedatives, Bilirubin(mg/dl), Creatinine (mg/dl) and platelets. All values are rated with a value of 1 to 4 (worst condition) and are added up gradually to a final score. The lower the SOFA score, the better is the prognosis (Maximum value 24)

  [Day 1, Visit 2] to Day 8 [Visit 9]

Secondary Outcomes (9)

• Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection

  Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]

• Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality

  Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]

• Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19

  Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]

• Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19

  Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]

• 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

  Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]

Study Arms (2)

COVID-19 convalescent plasma

EXPERIMENTAL

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

Biological: COVID-19 convalescent plasma

Standard treatment

NO INTERVENTION

Standard treatment.

Interventions

COVID-19 convalescent plasma 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.

COVID-19 convalescent plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject aged ≥18 years.
• Estimated BMI ≥19kg/m² to ≤40kg/m².
• Florid1 SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
• ARDS with Horovitz index \<300mmHg.
• Necessity of invasive mechanical ventilation.
• Written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in Germany (
• Subject's assent if obtainable

You may not qualify if:

• Previous exposure to COVID-19 convalescent plasma.
• Adverse reaction to plasma proteins in medical history.
• Interval \>72h since endotracheal intubation.
• Current or imminent necessity of ECMO treatment.
• Pre-existing COPD GOLD stage 4.
• Chronic congestive heart failure NYHA ≥3.
• Pre-existing left ventricular ejection fraction \<30%.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, Germany

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Carsten Willam, MD

  University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Schiffer, MD

CONTACT

+49913185; mario.schiffer@uk-erlangen.de

Holger Hackstein, MD

CONTACT

+49913185; Holger.Hackstein@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 15, 2021
• Study Start: January 18, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)