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COVID-19 Convalescent Plasma

Primary Purpose

Coronavirus

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
anti-SARS-CoV-2 convalescent plasma
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus focused on measuring COVID19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Donor Inclusion Criteria:

  • Age greater or equal to 18
  • Able to donate blood per blood bank standard guidelines
  • Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
  • Complete resolution of symptoms at least 28 days prior to donation
  • Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors

Donor Exclusion Criteria:

  • Does not provide consent
  • Does not meet standard blood bank donation guidelines
  • Unsuccessful blood donation

Recipient Inclusion Criteria:

  • Patients must be 18 years of age or older
  • Must have laboratory-confirmed COVID-19

  • Must have severe or immediately life-threatening COVID-19

    • Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
    • Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
  • Must be less than 21 days from the start of illness
  • Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
  • Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
  • Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma

Recipient Exclusion Criteria:

  • Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
  • Receipt of pooled immunoglobulin in past 30 days
  • Contraindication to transfusion or history of prior reactions to transfusion blood products
  • Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma

Sites / Locations

  • University of Chicago Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with anti-SARS-CoV-2 convalescent plasma

Arm Description

Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours

Outcomes

Primary Outcome Measures

Feasibility of performing study pathway consisting of consenting convalescent donors, harvesting convalescent plasma, application for FDA eIND and administering convalescent plasma to the patients
Feasibility will be measured by (number of donors from whom convalescent plasma is harvested/number of interested donors) and number of patients who receive convalescent plasma at day 28.
Type of respiratory support
Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.

Secondary Outcome Measures

Cardiac arrest
This will be a continuous outcome defined by the amount of time between plasma administration and cardiac arrest.
Transfer to ICU
This will be a continuous outcome defined by the amount of time between plasma administration and transfer to ICU.
ICU mortality
This will be a binary outcome defined by the amount of time between plasma administration and mortality in the ICU.
ICU length of stay
This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.
Hospital mortality
This will be a binary outcome defined by the amount of time between plasma administration and in-hospital mortality.
Hospital length of stay
This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.
Ventilator-free days
This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.
Overall survival (28-day mortality)
28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.

Full Information

First Posted
April 7, 2020
Last Updated
December 23, 2020
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04340050
Brief Title
COVID-19 Convalescent Plasma
Official Title
Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
December 23, 2020 (Actual)
Study Completion Date
December 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers. Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus
Keywords
COVID19

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with anti-SARS-CoV-2 convalescent plasma
Arm Type
Experimental
Arm Description
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours
Intervention Type
Biological
Intervention Name(s)
anti-SARS-CoV-2 convalescent plasma
Intervention Description
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours
Primary Outcome Measure Information:
Title
Feasibility of performing study pathway consisting of consenting convalescent donors, harvesting convalescent plasma, application for FDA eIND and administering convalescent plasma to the patients
Description
Feasibility will be measured by (number of donors from whom convalescent plasma is harvested/number of interested donors) and number of patients who receive convalescent plasma at day 28.
Time Frame
28 days after plasma administration
Title
Type of respiratory support
Description
Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.
Time Frame
28 days after plasma administration
Secondary Outcome Measure Information:
Title
Cardiac arrest
Description
This will be a continuous outcome defined by the amount of time between plasma administration and cardiac arrest.
Time Frame
28 days after plasma administration
Title
Transfer to ICU
Description
This will be a continuous outcome defined by the amount of time between plasma administration and transfer to ICU.
Time Frame
28 days
Title
ICU mortality
Description
This will be a binary outcome defined by the amount of time between plasma administration and mortality in the ICU.
Time Frame
28 days
Title
ICU length of stay
Description
This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.
Time Frame
28 days
Title
Hospital mortality
Description
This will be a binary outcome defined by the amount of time between plasma administration and in-hospital mortality.
Time Frame
28 days
Title
Hospital length of stay
Description
This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.
Time Frame
28 days
Title
Ventilator-free days
Description
This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.
Time Frame
28 days
Title
Overall survival (28-day mortality)
Description
28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Donor Inclusion Criteria: Age greater or equal to 18 Able to donate blood per blood bank standard guidelines Prior diagnosis of COVID-19 documented by a laboratory test (confirmed) Complete resolution of symptoms at least 28 days prior to donation Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors Donor Exclusion Criteria: Does not provide consent Does not meet standard blood bank donation guidelines Unsuccessful blood donation Recipient Inclusion Criteria: Patients must be 18 years of age or older Must have laboratory-confirmed COVID-19 Must have severe or immediately life-threatening COVID-19 Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy. Must be less than 21 days from the start of illness Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act Patient, power of attorney or health care proxy agrees to storage of specimens for future testing. Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma Recipient Exclusion Criteria: Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period Receipt of pooled immunoglobulin in past 30 days Contraindication to transfusion or history of prior reactions to transfusion blood products Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Lucia Madariaga, MD
Organizational Affiliation
University of Chicago Biological Sciences Division Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share individual participant data that is de-identified available to all qualified investigators
IPD Sharing Time Frame
Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database
Citations:
PubMed Identifier
34013969
Citation
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Results Reference
derived
PubMed Identifier
33044747
Citation
Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
Results Reference
derived

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COVID-19 Convalescent Plasma

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