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

No longer available
Treatment IND/Protocol
COVID
SARS-COV2
Corona Virus Infection

Biological: Convalescent Plasma

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

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:

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

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
United States
Locations

UMass Medical School
Worcester, Massachusetts, United States

Jonathan Gerber, MD, Principal Investigator
UMASS MEDICAL SCHOOL

Jonathan Gerber
NCT Number
Keywords
Covid-19
Coronavirus
SARS-CoV2
MeSH Terms
COVID-19
Coronavirus Infections