Status:
NO_LONGER_AVAILABLE
Expanded Access to Convalescent Plasma for Treatment of COVID-19
Lead Sponsor:
Hackensack Meridian Health
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatenin...
Detailed Description
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatenin...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age at least 18 years
- Laboratory confirmed diagnosis of infection with SARS-CoV-2
- Admitted to the hospital for the treatment of COVID-19 complications
- 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
- Informed consent provided by the patient or healthcare proxy
- Severe COVID-19 is defined by one or more of the following:
- dyspnea
- respiratory frequency ≥ 30/min
- blood oxygen saturation ≤ 93%
- partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
- lung infiltrates \> 50% within 24 to 48 hours
- Life-threatening COVID-19 is defined as one or more of the following:
- respiratory failure/mechanical ventilation
- septic shock
- multiple organ dysfunction or failure
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04472572
Last Update
October 12 2022
Active Locations (1)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601