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Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19

Primary Purpose

COVID, Sars-CoV2, Corona Virus Infection

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Convalescent Plasma
Sponsored by
Jonathan Gerber
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for COVID focused on measuring COVID-19, Coronavirus, Sars-CoV2

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • At least 12 years of age
  • Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
  • Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.

  • Severe COVID-19 is defined by one or more of the following:

    1. Dyspnea
    2. Respiratory frequency ≥ 30/min
    3. Blood oxygen saturation ≤ 93%
    4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
    5. Lung infiltrates > 50% within 24-48 hours

  • Life-threatening COVID-19 is defined as one or more of the following:

    1. Respiratory failure
    2. Septic shock
    3. Multiple organ dysfunction or failure

Exclusion Criteria:

  • History of prior life-threatening reactions to transfusion of blood products
  • Not receiving other therapies that would preclude plasma transfusion

Sites / Locations

  • UMass Medical School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 20, 2020
Last Updated
May 23, 2023
Sponsor
Jonathan Gerber
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1. Study Identification

Unique Protocol Identification Number
NCT04445207
Brief Title
Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
Official Title
Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
Study Type
Expanded Access

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathan Gerber

4. Oversight

5. Study Description

Brief Summary
The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.
Detailed Description
As individuals are exposed to pathogens, the body's immune system works to create antibodies toward those pathogens. These antibodies can be found in the plasma portion of the blood. This plasma is referred to as "Convalescent plasma" and contains these infection fighting antibodies. Through a blood donation, this convalescent plasma is collected from a recovered person and transfused to a sick patient who is still fighting the same virus. This protocol will make convalescent COVID-19 plasma available to individuals who meet the eligibility criteria described.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Sars-CoV2, Corona Virus Infection
Keywords
COVID-19, Coronavirus, Sars-CoV2

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma
Intervention Description
One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Eligibility Criteria
Inclusion Criteria: At least 12 years of age Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status) Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease. Severe COVID-19 is defined by one or more of the following: Dyspnea Respiratory frequency ≥ 30/min Blood oxygen saturation ≤ 93% Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 Lung infiltrates > 50% within 24-48 hours Life-threatening COVID-19 is defined as one or more of the following: Respiratory failure Septic shock Multiple organ dysfunction or failure Exclusion Criteria: History of prior life-threatening reactions to transfusion of blood products Not receiving other therapies that would preclude plasma transfusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Gerber, MD
Organizational Affiliation
UMASS MEDICAL SCHOOL
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

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Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19

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