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.
Biological: Convalescent plasma
One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
Inclusion Criteria:
- age > 18 with one or more of the following: Dyspnea Respiratory rate >= 30 breaths/min
Oxygen saturation <=93% PaO2/FiO2 <300 Bilateral airspace opacities on chest
radiograph at 24 to 48 hours
Exclusion Criteria:
- Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA
ECMO
Henry Ford Hospital
Detroit, Michigan, United States
Geneva Tatem, MD, Principal Investigator
Henry Ford Health System