COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04456413

Michele L Donato

Not reported

2020-07-02

Terminated

RCT

Randomized

Crossover

Open label

single-center

Treatment

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

- 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

2

Hackensack Meridian Health

18

100

United States

Mild disease at enrollment

1: Mild disease at enrollment

21

Hospitalization Rate

None

Phase 2

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