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Convalescent Plasma for the Treatment of COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Convalescent Plasma
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years and older
  • Laboratory confirmed diagnosis of SARS-CoV-2
  • Admitted to an acute care facility for the treatment of COVID-19 complications
  • Informed consent provided by patient or legally authorized representative
  • Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease

Severe Disease defined as any of the following

  • Dyspnea
  • Respiratory rate > 30/minute
  • Oxygen saturation <94%
  • Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
  • Lung infiltrates >50% within 24 to 48 hours

Life-threatening disease defined as any of the following

  • Respiratory failure
  • Septic shock
  • Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy

Exclusion Criteria:

  • Receipt of pooled immunoglobulin in past 30 days
  • Contraindication to transfusion or history of prior reactions to transfusion blood products

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr

Outcomes

Primary Outcome Measures

Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2
Number of patients who are consented and ultimately receive convalescent plasma transfusion.

Secondary Outcome Measures

Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19
Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection
Length of hospital stay
Days of hospitalization
Length of Intensive Care Unit stay
Days of Intensive Care Unit management
Length of intubation
Days of intubation requirement
Survival to discharge
Proportion of patients who are successfully discharged from acute care facility
Changes in complete blood count in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma
BMP tests include measures of glucose, calcium, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, and creatinine. Changes of interest include those that are flagged as abnormal. Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Changes in d-dimer in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Changes in fibrinogen in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Changes in prothrombin time (PT) in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).

Full Information

First Posted
April 27, 2020
Last Updated
June 3, 2021
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04389710
Brief Title
Convalescent Plasma for the Treatment of COVID-19
Official Title
Convalescent Plasma for the Treatment of Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
November 3, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

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
Yes

5. Study Description

Brief Summary
This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.
Detailed Description
This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Provide access to COVID-19 convalescent plasma for patients infected with SARS-CoV-2 currently hospitalized in acute care facilities
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr
Intervention Type
Drug
Intervention Name(s)
Convalescent Plasma
Intervention Description
One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma
Primary Outcome Measure Information:
Title
Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2
Description
Number of patients who are consented and ultimately receive convalescent plasma transfusion.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19
Description
Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection
Time Frame
0, 1, 2, 3, 7, 14 days
Title
Length of hospital stay
Description
Days of hospitalization
Time Frame
0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Title
Length of Intensive Care Unit stay
Description
Days of Intensive Care Unit management
Time Frame
0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Title
Length of intubation
Description
Days of intubation requirement
Time Frame
0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Title
Survival to discharge
Description
Proportion of patients who are successfully discharged from acute care facility
Time Frame
0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Title
Changes in complete blood count in patients after receiving convalescent plasma
Description
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Time Frame
0 and 7 days
Title
Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma
Description
BMP tests include measures of glucose, calcium, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, and creatinine. Changes of interest include those that are flagged as abnormal. Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Time Frame
0 and 7 days
Title
Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma
Description
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Time Frame
0 and 7 days
Title
Changes in d-dimer in patients after receiving convalescent plasma
Description
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Time Frame
0 and 7 days
Title
Changes in fibrinogen in patients after receiving convalescent plasma
Description
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Time Frame
0 and 7 days
Title
Changes in prothrombin time (PT) in patients after receiving convalescent plasma
Description
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Time Frame
0 and 7 days
Title
Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma
Description
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
Time Frame
0 and 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and older Laboratory confirmed diagnosis of SARS-CoV-2 Admitted to an acute care facility for the treatment of COVID-19 complications Informed consent provided by patient or legally authorized representative Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease Severe Disease defined as any of the following Dyspnea Respiratory rate > 30/minute Oxygen saturation <94% Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 Lung infiltrates >50% within 24 to 48 hours Life-threatening disease defined as any of the following Respiratory failure Septic shock Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy Exclusion Criteria: Receipt of pooled immunoglobulin in past 30 days Contraindication to transfusion or history of prior reactions to transfusion blood products
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Convalescent Plasma for the Treatment of COVID-19

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