Back to resultsConvalescent Plasma for Patients With COVID-19
Primary Purpose
Coronavirus Infection, Coronavirus, COVID
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Convalescent plasma
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus Infection focused on measuring COVID-19
Eligibility Criteria
Inclusion Criteria:
- age > 18 with one or more of the following: Dyspnea Respiratory rate >= 30 breaths/min Oxygen saturation <=93% PaO2/FiO2 <300 Bilateral airspace opacities on chest radiograph at 24 to 48 hours
Exclusion Criteria:
- Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA ECMO
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Convalescent Plasma Intervention
Standard Therapy Control
Arm Description
Convalescent plasma 200mL transfusion
Standard therapy for COVID-19 disease as defined by institutional protocols
Outcomes
Primary Outcome Measures
Change in Respiratory Disease Severity
Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion
Secondary Outcome Measures
ICU Length of Stay
Total ICU length of stay
Length of Stay
Hospital length of stay
Ventilator Days
Duration of time on ventilator
Number of Participants With Transfusion Adverse Events
Adverse transfusion events after 1 unit of convalescent plasma
Normal Chest X Ray at 28 Days
Change in Chest X Ray Findings
All-cause Mortality
All-cause overall deaths at end of trial at 28 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04385199
Brief Title
Convalescent Plasma for Patients With COVID-19
Official Title
The Use of Convalescent Plasma for Patients Hospitalized With COVID-19 Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 4, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.
Detailed Description
Importance: Convalescent plasma has been shown to be safe in patients with COVID-19, but whether it is clinically effective in patients with severe COVID-19 pneumonia is still unclear.
Objective: To evaluate the safety, tolerability, efficacy, and adverse events related to transfusion of convalescent plasma in patients hospitalized with severe or critical COVID-19 pneumonia.
Design, Setting and Participants: Randomized, single center, open-label, controlled trial of patients hospitalized between May 1, 2020, and August 1, 2020, with severe COVID-19 pneumonia in 1 tertiary care health system in the United States. A total of 30 participants age ≥ 18 years with 1 or more of the following were enrolled: dyspnea; respiratory rate > 30; O2 saturation ≤ 93%; PaO2/FiO2 or SaO2/FiO2 ratio < 300 mm Hg; and bilateral airspace opacities on chest x-ray > 50% within 24 to 48 hours.
Intervention: Transfusion with 1 unit of ABO compatible convalescent plasma in addition to standard care (n = 20) or standard care (n = 10). Standard care included steroids.
Main Outcomes and Measures: Primary outcome was improvement in oxygenation 72 hours after infusion measured by change in arterial blood gas or in PaO2/FiO2 or Sa/FiO2. Secondary outcomes were mortality at 28 days, days on mechanical ventilation, intensive care unit and hospital length of stay, and mSOFA score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Coronavirus, COVID
Keywords
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Convalescent Plasma Intervention
Arm Type
Experimental
Arm Description
Convalescent plasma 200mL transfusion
Arm Title
Standard Therapy Control
Arm Type
No Intervention
Arm Description
Standard therapy for COVID-19 disease as defined by institutional protocols
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
Primary Outcome Measure Information:
Title
Change in Respiratory Disease Severity
Description
Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion
Time Frame
day 3 post transfusion
Secondary Outcome Measure Information:
Title
ICU Length of Stay
Description
Total ICU length of stay
Time Frame
Up to 60 days At the end of the trial, if patients were still in the ICU, their date of transfer out of the ICU was collected and total ICU length of stay calculated.
Title
Length of Stay
Description
Hospital length of stay
Time Frame
Up to 60 days At the end of the trial, if patients were still in the hospital, their date of transfer out of the hospital was collected and hospital length of stay calculated.
Title
Ventilator Days
Description
Duration of time on ventilator
Time Frame
28 day
Title
Number of Participants With Transfusion Adverse Events
Description
Adverse transfusion events after 1 unit of convalescent plasma
Time Frame
From transfusion up to 1 day post-transfusion
Title
Normal Chest X Ray at 28 Days
Description
Change in Chest X Ray Findings
Time Frame
28 days
Title
All-cause Mortality
Description
All-cause overall deaths at end of trial at 28 days
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 with one or more of the following: Dyspnea Respiratory rate >= 30 breaths/min Oxygen saturation <=93% PaO2/FiO2 <300 Bilateral airspace opacities on chest radiograph at 24 to 48 hours
Exclusion Criteria:
Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA ECMO
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geneva Tatem, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Convalescent Plasma for Patients With COVID-19
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