NCT04343755

Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Convalescent Plasma	Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection

Timeline

• Start date: 2020-04-09
• Primary completion: 2023-04-26
• Completion: 2023-04-26
• First posted: 2020-04-13
• Last updated: 2023-09-18
• Results posted: 2023-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study