Convalescent Plasma for the Treatment of COVID-19

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Thomas Jefferson University
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Updated on 16 February 2024
See if I qualify
shock
FIO2
dyspnea
oximetry
covid-19
SARS
respiratory failure
fraction of inspired oxygen (fio2)
acute respiratory syndrome (sars)

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 healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.

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 severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma
(https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemptio n-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

Details
Condition Covid 19
Age 18years - 100years
Treatment Convalescent plasma
Clinical Study IdentifierNCT04389710
SponsorThomas Jefferson University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

Receipt of pooled immunoglobulin in past 30 days
Contraindication to transfusion or history of prior reactions to transfusion blood products
Clear my responses
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