Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Hackensack Meridian Health
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Hospitalization Rate
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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 completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
- Subjects will be randomized to receiving convalescent plasma or best supportive care.
- Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
- The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.
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 considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. * Subjects will be randomized to receiving convalescent plasma or best supportive care. * Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. * The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study. A total of 306 subjects will be recruited, 153 for each arm. If a patient in the best supportive care arm requires hospitalization, the patient will be eligible to receive convalescent plasma if requested and/or deemed medically appropriate by the admitting physician. Overall study duration * The study begins when the first subject (donor or recipient) 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Hospitalization Rate
Time Frame: 10 Days
The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
Secondary Outcomes
- Time to Symptoms Resolution(2 Months)
- Overall Survival Rate(2 Months)
- Rate of Nasopharyngeal Swab Positivity in Donors(2 Months)
- Rate of Virologic Clearance by Nasopharyngeal Swab at 2 Weeks(2 Weeks)
- Rate of Donor Titers Level(2 Months)
- Impact of Donor Titers Level on Efficacy(2 Months)
- Patients' Anti-SARS-CoV2 Titer Assessment Pre-infusion for the Treatment Group, at 2 Weeks , 4 Weeks and 2 Months.(Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months)
- Rate of Virologic Clearance by Nasopharyngeal Swab at 4 Weeks(4 Weeks)