Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.
Importance: Convalescent plasma has been shown to be safe in patients with COVID-19, but whether it is clinically effective in patients with severe COVID-19 pneumonia is still unclear. Objective: To evaluate the safety, tolerability, efficacy, and adverse events related to transfusion of convalescent plasma in patients hospitalized with severe or critical COVID-19 pneumonia. Design, Setting and Participants: Randomized, single center, open-label, controlled trial of patients hospitalized between May 1, 2020, and August 1, 2020, with severe COVID-19 pneumonia in 1 tertiary care health system in the United States. A total of 30 participants age ≥ 18 years with 1 or more of the following were enrolled: dyspnea; respiratory rate \> 30; O2 saturation ≤ 93%; PaO2/FiO2 or SaO2/FiO2 ratio \< 300 mm Hg; and bilateral airspace opacities on chest x-ray \> 50% within 24 to 48 hours. Intervention: Transfusion with 1 unit of ABO compatible convalescent plasma in addition to standard care (n = 20) or standard care (n = 10). Standard care included steroids. Main Outcomes and Measures: Primary outcome was improvement in oxygenation 72 hours after infusion measured by change in arterial blood gas or in PaO2/FiO2 or Sa/FiO2. Secondary outcomes were mortality at 28 days, days on mechanical ventilation, intensive care unit and hospital length of stay, and mSOFA score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
Henry Ford Hospital
Detroit, Michigan, United States
Change in Respiratory Disease Severity
Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion
Time frame: day 3 post transfusion
ICU Length of Stay
Total ICU length of stay
Time frame: Up to 60 days At the end of the trial, if patients were still in the ICU, their date of transfer out of the ICU was collected and total ICU length of stay calculated.
Length of Stay
Hospital length of stay
Time frame: Up to 60 days At the end of the trial, if patients were still in the hospital, their date of transfer out of the hospital was collected and hospital length of stay calculated.
Ventilator Days
Duration of time on ventilator
Time frame: 28 day
Number of Participants With Transfusion Adverse Events
Adverse transfusion events after 1 unit of convalescent plasma
Time frame: From transfusion up to 1 day post-transfusion
Normal Chest X Ray at 28 Days
Change in Chest X Ray Findings
Time frame: 28 days
All-cause Mortality
All-cause overall deaths at end of trial at 28 days
Time frame: 28 days
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