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Use of Convalescent Plasma for COVID-19

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ClinicalTrials.gov Identifier: NCT04408040
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Northside Hospital, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID Biological: Convalescent Plasma Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024
Arms and Interventions
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Arm Intervention/treatment
Critical Patients Biological: Convalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19
Severe Patients Biological: Convalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19
High Risk Biological: Convalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19
Health Care Providers Biological: Convalescent Plasma
200-425mL convalescent plasma donated by patients previously positive for COVID-19


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • History of IgA deficiency
  • History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408040


Contacts
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Contact: Stacey Brown 404-780-7965 stacey.brown@northside.com

Locations
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United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Stacey Brown, BA    404-780-7965    stacey.brown@northside.com   
Contact: Caitlin Guzowski, MBA, MHA    404-851-8523    caitlin.guzowski@northside.com   
Sub-Investigator: H. Kent Holland, MD         
Sub-Investigator: Asad Bashey, MD         
Sub-Investigator: Lawrence E Morris, MD         
Sub-Investigator: Scott Solomon, MD         
Principal Investigator: Melhem Solh, MD         
Sponsors and Collaborators
Northside Hospital, Inc.
Investigators
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Principal Investigator: Kent Holland, MD Northside Hospital
More Information
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Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT04408040    
Other Study ID Numbers: NSH 1281
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No