Use of Convalescent Plasma for COVID-19

Purpose

The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.

Condition

  • COVID

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Documented COVID-19 infection by nasal pharyngeal sampling - COVID-19 disease falling into one of the following groups: - Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure - Severe disease: tachypnea >/=30 per min, O2 sats </=93% at rest, PaO2/FiO2 index </=300mmHg - High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI >/=40, age >/=65 years - Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease

Exclusion Criteria

  • History of IgA deficiency - History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Critical Patients
  • Biological: Convalescent Plasma
    200-425mL convalescent plasma donated by patients previously positive for COVID-19
Other
Severe Patients
  • Biological: Convalescent Plasma
    200-425mL convalescent plasma donated by patients previously positive for COVID-19
Other
High Risk
  • Biological: Convalescent Plasma
    200-425mL convalescent plasma donated by patients previously positive for COVID-19
Other
Health Care Providers
  • Biological: Convalescent Plasma
    200-425mL convalescent plasma donated by patients previously positive for COVID-19

Recruiting Locations

More Details

NCT ID
NCT04408040
Status
Terminated
Sponsor
Northside Hospital, Inc.