Use of Convalescent Plasma for COVID-19

Northside Hospital, Inc.

Status and phase: Terminated; Phase 2

Conditions: COVID

Treatments: Biological: Convalescent Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04408040

NSH 1281

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

Critical Patients

Other group

Treatment:

Biological: Convalescent Plasma

Severe Patients

Other group

Treatment:

Biological: Convalescent Plasma

High Risk

Other group

Treatment:

Biological: Convalescent Plasma

Health Care Providers

Other group

Treatment:

Biological: Convalescent Plasma