Use of Convalescent Plasma for COVID-19

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2022

Interventions

  • Biological: Convalescent Plasma
    • 200-425mL convalescent plasma donated by patients previously positive for COVID-19

Arms, Groups and Cohorts

  • Other: Critical Patients
  • Other: Severe Patients
  • Other: High Risk
  • Other: Health Care Providers

Clinical Trial Outcome Measures

Primary Measures

  • Arms 1 & 2: number of critical and severe COVID-19 infected patients who are transfused with convalescent plasma result in lower death rates than the reported fatality rate
    • Time Frame: 30 days after initial treatment
    • To estimate infection-related mortality rates
  • Arms 1 & 2: number of critical and severe COVID-19 infected patients who survive the infection
    • Time Frame: 30 days after initial treatment
    • To estimate overall survival
  • Arm 3: number of high risk COVID-19 infected patients who are transfused with convalescent plasma result in lower incidence of progression to severe or critical disease than the reported case rate
    • Time Frame: 30 days after initial treatment
    • To estimate progression incidence rates
  • Arm 4: number of health care providers who are at risk to exposure to COVID-19 who are transfused with convalescent plasma result in lower incidence of developing COVID-19 infection than the reported case rate
    • Time Frame: 30 days after initial treatment
    • To estimate the rate of infection among healthy persons exposed to COVID-19

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northside Hospital, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kent Holland, MD, Principal Investigator, Northside Hospital
  • Overall Contact(s)
    • Stacey Brown, 404-780-7965, stacey.brown@northside.com

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