Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden
et al., BMC Research Notes,
RCT 31 hospitalized patients requiring supplemental oxygen in Sweden, showing no significant difference in outcomes with convalescent plasma.
risk of death, 45.1% lower, RR 0.55, p = 0.64, treatment 2 of 17 (11.8%), control 3 of 14 (21.4%), NNT 10.
risk of mechanical ventilation, 68.9% lower, RR 0.31, p = 0.45, treatment 0 of 17 (0.0%), control 1 of 14 (7.1%), NNT 14, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of progression, 18.8% lower, RR 0.81, p = 1.00, treatment 4 of 16 (25.0%), control 4 of 13 (30.8%), NNT 17, progression to HFNC.
oxygen time, 57.1% higher, relative time 1.57, p = 0.43, treatment 17, control 14.
hospitalization time, 62.5% higher, relative time 1.62, p = 0.21, treatment 17, control 14.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Holm et al., 4 Dec 2021, Randomized Controlled Trial, Sweden, peer-reviewed, 14 authors, study period June 2020 - January 2021, trial NCT04600440 (history)
firstname.lastname@example.org (corresponding author).
Abstract: (2021) 14:440
Holm et al. BMC Research Notes
BMC Research Notes
Convalescence plasma treatment
of COVID‑19: results from a prematurely
terminated randomized controlled open‑label
study in Southern Sweden
Karin Holm1*† , Maria N. Lundgren2†, Jens Kjeldsen‑Kragh2, Oskar Ljungquist3, Blenda Böttiger4,
Christian Wikén1, Jonas Öberg1, Nils Fernström1, Ebba Rosendal5, Anna K. Överby5, Julia Wigren Byström5,
Mattias Forsell5, Mona Landin‑Olsson6† and Magnus Rasmussen1†
Objective: 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.
Results: 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.
Keywords: SARS-CoV2, COVID-19, Convalescent plasma, Oxygen therapy, Desaturation
is less effective
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