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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.