Official Title
The Use of Convalescent Plasma for Patients Hospitalized With COVID-19 Disease
Brief Summary

Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.

Detailed Description

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.

Completed
Coronavirus Infection
Coronavirus
COVID

Biological: Convalescent plasma

One 200mL transfusion of ABO compatible convalescent plasma over 3 hours

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Henry Ford Hospital
Detroit, Michigan, United States

Geneva Tatem, MD, Principal Investigator
Henry Ford Health System

Henry Ford Health System
NCT Number
Keywords
Covid-19
MeSH Terms
COVID-19
Coronavirus Infections