Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden.
Karin HolmMaria N LundgrenJens Kjeldsen-KraghOskar LjungquistBlenda BöttigerChristian WikénJonas ÖbergNils FernströmEbba RosendalAnna K ÖverbyJulia Wigren ByströmMattias ForsellMona Landin-OlssonMagnus RasmussenPublished in: BMC research notes (2021)
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.
Keyphrases
- open label
- end stage renal disease
- healthcare
- palliative care
- newly diagnosed
- chronic kidney disease
- phase iii
- quality improvement
- prognostic factors
- sars cov
- phase ii
- clinical trial
- squamous cell carcinoma
- randomized controlled trial
- patient reported outcomes
- young adults
- radiation therapy
- optical coherence tomography
- chronic pain
- diabetic retinopathy
- phase ii study