Convalescent Plasma for the Treatment of COVID-19

June 3, 2021 updated by: Thomas Jefferson University

Convalescent Plasma for the Treatment of Patients With COVID-19

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr
Drug: Convalescent Plasma
One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2
Time Frame: 1 year
Number of patients who are consented and ultimately receive convalescent plasma transfusion.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19
Time Frame: 0, 1, 2, 3, 7, 14 days
Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection
0, 1, 2, 3, 7, 14 days
Length of hospital stay
Time Frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Days of hospitalization
0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Length of Intensive Care Unit stay
Time Frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Days of Intensive Care Unit management
0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Length of intubation
Time Frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Days of intubation requirement
0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Survival to discharge
Time Frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Proportion of patients who are successfully discharged from acute care facility
0, 1, 2, 3, 7, 14, 28, 60, and 90 days
Changes in complete blood count in patients after receiving convalescent plasma
Time Frame: 0 and 7 days
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
0 and 7 days
Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma
Time Frame: 0 and 7 days
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).
0 and 7 days
Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma
Time Frame: 0 and 7 days
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
0 and 7 days
Changes in d-dimer in patients after receiving convalescent plasma
Time Frame: 0 and 7 days
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
0 and 7 days
Changes in fibrinogen in patients after receiving convalescent plasma
Time Frame: 0 and 7 days
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
0 and 7 days
Changes in prothrombin time (PT) in patients after receiving convalescent plasma
Time Frame: 0 and 7 days
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
0 and 7 days
Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma
Time Frame: 0 and 7 days
Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).
0 and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20D.379

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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