Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak

Northside Hospital, Inc.1 site in 1 country8 target enrollmentJuly 14, 2020

ConditionsCOVID

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID
Sponsor: Northside Hospital, Inc.
Enrollment: 8
Locations: 1
Primary Endpoint: Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 14, 2020

End Date

September 14, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Northside Hospital, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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