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

NCT ID: NCT04445207

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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COVID Sars-CoV2 Corona Virus Infection

Interventions

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Convalescent Plasma

One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonathan Gerber

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Gerber

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jonathan Gerber, MD

Role: PRINCIPAL_INVESTIGATOR

UMASS MEDICAL SCHOOL

Locations

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UMass Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H000020420

Identifier Type: -

Identifier Source: org_study_id

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