Status:
TERMINATED
Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection
Lead Sponsor:
Hackensack Meridian Health
Collaborating Sponsors:
United States Department of Defense
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
* This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. * Subjects will be considered as having ...
Detailed Description
Overall study design * This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. * Subjects will be...
Eligibility Criteria
Inclusion
- Donor Eligibility Criteria:
- Age 18-60
- A history of a positive nasopharyngeal swab for COVID-19 or a history of positive antibody titer test.
- At least 14 days from resolution of COVID-19-associated symptoms including fevers.
- A negative nasopharyngeal swab (or similar test) for COVID-19
- anti-SARS-CoV2 titers \>1:500
- 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.
- 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:
- Patient age \>30 years old, newly diagnosed with a COVID-19 infection with onset of first symptoms \< 96 hours.
- And least one other high-risk feature:
- Age \> 65
- BMI 30 or above
- Hypertension, defined as SBP above 140 or DBP above 90, or requiring medication for control.
- Coronary artery disease (history, not ECG changes only)
- Congestive heart failure
- Peripheral vascular disease (includes aortic aneurysm \>= 6 cm)
- Cerebrovascular disease (history of CVA or TIA)
- Dementia
- Chronic pulmonary disease
- Liver disease (such as portal hypertension, chronic hepatitis)
- Diabetes (excludes diet-controlled alone)
- Moderate or severe renal disease defined as having a GFR \< 60 mL/min
- Cancer (exclude if \> 5 year in remission)
- AIDS (not just HIV positive)
- Recipient exclusion criteria:
- History of severe transfusion reaction to plasma products
- Need for oxygen supplementation
- Positive test for COVID-19 antibodies
- Chemotherapy-induced neutropenia (ANC \< 0.5 x 103/mcL)
- Immunosuppressive medications except for prednisone (or steroid equivalent) \> 10 mg daily.
- Performance status \< 50 by KPS
- Pneumonia by radiographic evaluation
Exclusion
Key Trial Info
Start Date :
November 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04456413
Start Date
November 6 2020
End Date
May 4 2021
Last Update
October 10 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