Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden.
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Holm K, Lundgren MN, Kjeldsen-Kragh J, Ljungquist O, Böttiger B, Wikén C, Öberg J, Fernström N, Rosendal E, Överby AK, Wigren Byström J, Forsell M, Landin-Olsson M, Rasmussen M
BMC Res Notes 14 (1) 440 [2021-12-04; online 2021-12-04]
Convalescent plasma has been tried as therapy for various viral infections. Early observational studies of convalescent plasma treatment for hospitalized COVID-19 patients were promising, but randomized controlled studies were lacking at the time. The objective of this study was to investigate if convalescent plasma is beneficial to hospitalized patients with COVID-19. Hospitalized patients with confirmed COVID-19 and an oxygen saturation below 94% were randomized 1:1 to receive convalescent plasma in addition to standard of care or standard of care only. The primary outcome was number of days of oxygen treatment to keep saturation above 93% within 28 days from inclusion. The study was prematurely terminated when thirty-one of 100 intended patients had been included. The median time of oxygen treatment among survivors was 11 days (IQR 6-15) for the convalescent plasma group and 7 days (IQR 5-9) for the standard of care group (p = 0.4, median difference -4). Two patients in the convalescent plasma group and three patients in the standard of care group died (p = 0.64, OR 0.49, 95% CI 0.08-2.79). Thus no significant differences were observed between the groups. Trial registration ClinicalTrials NCT04600440, retrospectively registered Oct 23, 2020.
PubMed 34863304
DOI 10.1186/s13104-021-05847-7
Crossref 10.1186/s13104-021-05847-7
pii: 10.1186/s13104-021-05847-7
ClinicalTrials.gov: NCT04600440