NCT04456413

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

Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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
OTHER	Best Supportive Care	Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.

Timeline

• Start date: 2020-11-06
• Primary completion: 2021-04-29
• Completion: 2021-05-04
• First posted: 2020-07-02
• Last updated: 2023-10-10
• Results posted: 2023-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study