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
• Status: No longer available

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• 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
• 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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID
• COVID-19
• Sars-CoV2

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,