NCT04340050

COVID-19 Convalescent Plasma

Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers. Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

Conditions

• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	anti-SARS-CoV-2 convalescent plasma	Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours

Timeline

• Start date: 2020-04-10
• Primary completion: 2020-12-23
• Completion: 2020-12-23
• First posted: 2020-04-09
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study