Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 55
Summary
- Conditions
- COVID-19
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first. Interim analysis w...
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 completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first. Interim analysis will be permitted as described in the statistical section 8. The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study. Number of subjects • Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8. Overall study duration The study begins when the first subject (this will likely be a donor) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient). The expected duration of the study is approximately 12 months.
Tracking Information
- NCT #
- NCT04343755
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michele L Donato, MD Hackensack Meridian Health
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