Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial

DOI record: { "DOI": "10.1183/13993003.01471-2021", "ISSN": [ "0903-1936", "1399-3003" ], "URL": "http://dx.doi.org/10.1183/13993003.01471-2021", "abstract": "<jats:sec><jats:title>Background</jats:title><jats:p>The effects of convalescent plasma (CP) therapy in hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect of CP on clinical improvement in these patients.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 160 (80 in each arm) patients (66.3% critically ill, 33.7% severely ill) completed the trial. The median (interquartile range (IQR)) age was 60.5 (48–68) years; 58.1% were male and the median (IQR) time from symptom onset to randomisation was 10 (8–12) days. Neutralising antibody titres &gt;1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC group and 65.0% in the SOC group (difference −3.7%, 95% CI −18.8–11.3%). The results were similar in the severe and critically ill subgroups. There was no significant difference between CP+SOC and SOC groups in pre-specified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratory marker values on days 3, 7 and 14 were similar between groups.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>CP+SOC did not result in a higher proportion of clinical improvement on day 28 in hospitalised patients with COVID-19 compared to SOC alone.</jats:p></jats:sec>", "alternative-id": [ "10.1183/13993003.01471-2021" ], "author": [ { "ORCID": "http://orcid.org/0000-0002-7140-4980", "affiliation": [], "authenticated-orcid": false, "family": "Sekine", "given": "Leo", "sequence": "first" }, { "affiliation": [], "family": "Arns", "given": "Beatriz", "sequence": "additional" }, { "affiliation": [], "family": "Fabro", "given": "Bruna R.", "sequence": "additional" }, { "affiliation": [], "family": "Cipolatt", "given": "Murillo M.", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0001-6974-5092", "affiliation": [], "authenticated-orcid": false, "family": "Machado", "given": "Rafael R.G.", "sequence": "additional" }, 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