Use of Convalescent Plasma for COVID-19

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

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.

Study Overview

• Status: Terminated
• Conditions: COVID
• Intervention / Treatment: Biological: Convalescent Plasma

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northside Hospital, Inc.
• Investigators: Principal Investigator: Kent Holland, MD, Northside Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Actual): September 14, 2021
• Study Completion (Actual): September 14, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NSH 1281

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No