A Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anti-SARS-CoV-2 convalescent plasma
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years or older
- Hospitalized as an in-patient with positive COVID-19 test by PCR
Presence of respiratory symptoms with any of severe features as below:
- Respiratory Rate ≥ 24/min
- Oxygen Support >3L/min by nasal cannula
- New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause
- Patient / HCPOA must agree to storage of blood specimens for future testing.
- Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
- Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.
Exclusion Criteria:
- FCBP with positive pregnancy test (mandatory)
- Breastfeeding females
- Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
- Mechanical ventilation for > 14 days
- Days from symptom onset >21 days
- Expected survival < 72 hours
- Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI
- Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .
Sites / Locations
- Froedtert Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ICU Cohort
Non-ICU Cohort
Arm Description
Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
Outcomes
Primary Outcome Measures
Overall Mortality within 60 days
Overall mortality within 60 days
Secondary Outcome Measures
Length of ICU stay during current admission for COVID
length of admission for COVID
Full Information
NCT ID
NCT04354831
First Posted
April 14, 2020
Last Updated
August 23, 2022
Sponsor
Medical College of Wisconsin
Collaborators
Froedtert Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04354831
Brief Title
A Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection
Official Title
An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Froedtert Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.
Detailed Description
This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
131 patients in 2 cohorts (ICU cohort and a hospitalized non-ICU cohort)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICU Cohort
Arm Type
Experimental
Arm Description
Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
Arm Title
Non-ICU Cohort
Arm Type
Experimental
Arm Description
Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
Intervention Type
Biological
Intervention Name(s)
anti-SARS-CoV-2 convalescent plasma
Intervention Description
SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL maximum dose as 7 ml/kg adjusted IBW )
Study drug will be administered as a single intravenous infusion
Primary Outcome Measure Information:
Title
Overall Mortality within 60 days
Description
Overall mortality within 60 days
Time Frame
sixty days from infusion of plasma
Secondary Outcome Measure Information:
Title
Length of ICU stay during current admission for COVID
Description
length of admission for COVID
Time Frame
Length of admission for COVID through study follow-up period, an average of 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years or older
Hospitalized as an in-patient with positive COVID-19 test by PCR
Presence of respiratory symptoms with any of severe features as below:
Respiratory Rate ≥ 24/min
Oxygen Support >3L/min by nasal cannula
New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause
Patient / HCPOA must agree to storage of blood specimens for future testing.
Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.
Exclusion Criteria:
FCBP with positive pregnancy test (mandatory)
Breastfeeding females
Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
Mechanical ventilation for > 14 days
Days from symptom onset >21 days
Expected survival < 72 hours
Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI
Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Beth Graham
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection
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