Use of Convalescent Plasma for COVID-19

Phase 2

Terminated

• Conditions: COVID
• Interventions: Biological: Convalescent Plasma

• Registration Number: NCT04408040
• Lead Sponsor: Northside Hospital, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Study Start: 2020-07-14
• Primary Completion: 2021-09-14
• Study Completion: 2021-09-14
• Results First Submitted: 2021-11-23
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-19
• Last Update Submitted: 2022-10-19
• Results First Posted: 2022-11-14
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Care Providers	Convalescent Plasma	-
Severe Patients	Convalescent Plasma	-
High Risk	Convalescent Plasma	-
Critical Patients	Convalescent Plasma	-

Primary Outcome Measures

Name	Time	Method
Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection	30 days after initial treatment	Number of patients who survived the covid infection after treatment on study.

Trial Locations

Locations (1)

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States