Convalescent Plasma for Covid-19–Induced ARDS in Mechanically Ventilated Patients

BACKGROUND
Passive immunization with plasma collected from convalescent patients has been
regularly used to treat coronavirus disease 2019 (Covid-19). Minimal data are avail-
able regarding the use of convalescent plasma in patients with Covid-19–induced
acute respiratory distress syndrome (ARDS).
METHODS
In this open-label trial, we randomly assigned adult patients with Covid-19–induced
ARDS who had been receiving invasive mechanical ventilation for less than 5 days
in a 1:1 ratio to receive either convalescent plasma with a neutralizing antibody titer
of at least 1:320 or standard care alone. Randomization was stratified according to
the time from tracheal intubation to inclusion. The primary outcome was death by
day 28.
RESULTS
A total of 475 patients underwent randomization from September 2020 through
March 2022. Overall, 237 patients were assigned to receive convalescent plasma
and 238 to receive standard care. Owing to a shortage of convalescent plasma, a
neutralizing antibody titer of 1:160 was administered to 17.7% of the patients in
the convalescent-plasma group. Glucocorticoids were administered to 466 patients
(98.1%). At day 28, mortality was 35.4% in the convalescent-plasma group and
45.0% in the standard-care group (P = 0.03). In a prespecified analysis, this effect
was observed mainly in patients who underwent randomization 48 hours or less
after the initiation of invasive mechanical ventilation. Serious adverse events did
not differ substantially between the two groups.
CONCLUSIONS
The administration of plasma collected from convalescent donors with a neutralizing
antibody titer of at least 1:160 to patients with Covid-19–induced ARDS within 5 days
after the initiation of invasive mechanical ventilation significantly reduced mortality
at day 28. This effect was mainly observed in patients who underwent randomization
48 hours or less after ventilation initiation. (Funded by the Belgian Health Care Knowl-
edge Center; ClinicalTrials.gov number, NCT04558476.)