COVID-19 Convalescent Plasma
NCT04340050 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2024-02-28
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
- BIOLOGICAL
-
anti-SARS-CoV-2 convalescent plasma
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
Sponsors & Collaborators
-
University of Chicago
lead OTHER
Principal Investigators
-
Maria Lucia Madariaga, MD · University of Chicago Biological Sciences Division Department of Surgery
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-10
- Primary Completion
- 2020-12-23
- Completion
- 2020-12-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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