Status:
TERMINATED
Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection
Lead Sponsor:
Hackensack Meridian Health
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
* This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection. * Subjects will be considered as having completed the study after 6...
Detailed Description
Overall study design * This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection. * Subjects will be considered as having compl...
Eligibility Criteria
Inclusion
- Donor Eligibility Criteria:
- Age 18-60
- A history of a positive nasopharyngeal swab for COVID-19 or a history of positive titer test.
- At least 14 days from resolution of COVID-19-associated symptoms including fevers
- One negative nasopharyngeal swabs for COVID-19 RNA
- Covid-19 neutralizing antibody \>1:64
- Adequate venous access for apheresis
- Meets donor eligibility criteria in accordance to Hackensack University Medical Center (HUMC) Collection Facility at the John Theurer Cancer Center (JTCC) if collecting at the JTCC, and all regulatory agencies as describes in SOP 800 01 (Appendix A)
- Required testing of the donor and product must be performed in accordance to FDA regulations (21 CFR 610.40), and the donation must be found suitable (21 CFR 630.30)
- Recipient Eligibility Criteria:
- Recipients age \>18 years old, are assigned to one of two clinical tracks, track 2 or 3, based on COVID-19 disease severity. Onset of first symptoms \< 9 days.
- Track 2:
- Hospitalized, moderate symptoms requiring medical care for COVID-19 infection
- Symptoms may include fever, dyspnea, dehydration among others
- Hypoxemia may be present but is not a requirement
- Track 3:
- Requiring mechanical ventilation for the care of COVID-19 infection
- Requiring non-invasive positive pressure ventilation (NIPPV), such as continuous airway pressure (CPAP),bi-level positive airway pressure (BiPAP) or high flow nasal canula (HFNC).
- Recipient exclusion criteria:
- History of severe transfusion reaction to plasma products
- Infusion of immune globulin within the previous 30 days
- AST or ALT \> 10 x upper limit of normal
- Requirement for vasopressors
- COVID-19-associated acute kidney injury requiring dialysis
- DNR status
Exclusion
Key Trial Info
Start Date :
April 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04343755
Start Date
April 9 2020
End Date
April 26 2023
Last Update
September 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601