Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Hackensack Meridian Health
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Number of Participants Hospitalized for COVID-19 But Not Intubated
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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 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.
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants Hospitalized for COVID-19 But Not Intubated
Time Frame: 7 Days
Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Primary Objective for Patients With COVID-19 Already Intubated
Time Frame: 30 Days
Mortality rate at 30 days from starting treatment for patients with COVID-19
Secondary Outcomes
- Time to Symptoms Resolution(60 Days)
- Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30(30 Days)
- Impact of Donor Titers Level on Efficacy(60 Days)
- Duration of Hospitalization(60 Days)
- Duration of Mechanical Ventilation(60 Days)
- Impact of Donor Titers Level on Safety(60 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)(0 Days (pre-infusion))
- Recipient Anti-SARS-CoV2 Titer Assessment on Days 3(3 Days)
- Overall Survival(60 Days)
- Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10(10 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Day 10(10 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Day 30(30 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Day 60(60 Days)