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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours
University of Chicago Medicine
Chicago, Illinois, United States
Success of Administering Plasma
Number of patients who receive convalescent plasma
Time frame: At time of administration
Type of Respiratory Support
Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.
Time frame: Until discharge from hospital
Cardiac Arrest
Number of patients experiencing cardiac arrest.
Time frame: 28 days after plasma administration
Transfer to ICU
Number of patients transferred to ICU
Time frame: 28 days
ICU Mortality
Number of patients dying in the ICU
Time frame: Until discharge
ICU Length of Stay
This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.
Time frame: Up to 50 days
Hospital Mortality
Mortality during course of illness
Time frame: Until discharge
Hospital Length of Stay
This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.
Time frame: Until discharge
Ventilator-free Days
This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.
Time frame: 28 days
Overall Survival (28-day Mortality)
28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.
Time frame: 28 days
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