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NCT04445207 Clinical Trial

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

COVID Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04445207
Other study ID # H000020420
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date May 2023
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States UMass Medical School Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Jonathan Gerber

Country where clinical trial is conducted

United States, 

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