Status:
COMPLETED
Convalescent Plasma for the Treatment of COVID-19
Lead Sponsor:
Thomas Jefferson University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a...
Detailed Description
This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have sever...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Laboratory confirmed diagnosis of SARS-CoV-2
- Admitted to an acute care facility for the treatment of COVID-19 complications
- Informed consent provided by patient or legally authorized representative
- Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
- Severe Disease defined as any of the following
- Dyspnea
- Respiratory rate \> 30/minute
- Oxygen saturation \<94%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300
- Lung infiltrates \>50% within 24 to 48 hours
- Life-threatening disease defined as any of the following
- Respiratory failure
- Septic shock
- Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy
Exclusion
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04389710
Start Date
April 15 2020
End Date
December 7 2020
Last Update
June 4 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107