{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T16:22:22Z","timestamp":1787847742805,"version":"build-2784847793"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To present the interim findings from a national study investigating the safety and efficacy of convalescent plasma (CP) containing detectable IgG antibodies as a treatment strategy for severe coronavirus disease 2019 (COVID-19).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Design and Participants:<\/jats:title>\n                    <jats:p>\n                      An open label, two-arm, phase-II clinical trial conducted across 22 hospitals from Saudi Arabia. The intervention group included 40 adults (aged \u226518 years) with confirmed severe COVID-19 and the control group included 124 patients matched using propensity score for age, gender, intubation status, and history of diabetes and\/or hypertension. Intervention group included those (a) with severe symptoms (dyspnea; respiratory rate, \u226530\/min; SpO\n                      <jats:sub>2<\/jats:sub>\n                      , \u226493%, PaO2\/FiO2 ratio, &lt;300; and\/or lung infiltrates &gt;50% within 24\u201348 h), (b) requiring intensive care unit (ICU) care or (c) experiencing life-threatening conditions. The control group included confirmed severe COVID-19 patients of similar characteristics who did not consent for CP infusion or were not able to receive CP due to its nonavailability.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions:<\/jats:title>\n                    <jats:p>The intervention group participants were infused 300 ml (200\u2013400 ml\/treatment dose) CP at least once, and if required, daily for up to 5 sessions, along with receiving the best standard of care. The control group only received the best standard of care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes:<\/jats:title>\n                    <jats:p>The primary endpoints were safety and ICU length of stay (LOS). The secondary endpoints included 30-day mortality, days on mechanical ventilation and days to clinical recovery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      CP transfusion did not result in any adverse effects. There was no difference in the ICU LOS (median 8 days in both groups). The mortality risk was lower in the CP group: 13% absolute risk reduction (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.147), hazard ratio (95% confidence interval): 0.554 (0.299\u20131.027;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.061) by log-rank test. There was no significant difference in the days on mechanical ventilation and days to clinical recovery.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>CP containing detectable antibodies is a safe strategy and may result in a decrease in mortality in patients with severe COVID-19. The results of the completed trial with a larger study sample would provide more clarity if this difference in mortality is significant.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration:<\/jats:title>\n                    <jats:p>ClinicalTrials.gov Identifier: NCT04347681; Saudi Clinical Trials Registry No.: 20041102.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.4103\/sjmms.sjmms_731_20","type":"journal-article","created":{"date-parts":[[2020,12,26]],"date-time":"2020-12-26T01:05:48Z","timestamp":1608944748000},"page":"16-23","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":16,"title":["Safety and Efficacy of Convalescent Plasma for Severe COVID-19"],"prefix":"10.4103","volume":"9","author":[{"given":"Nawal","family":"AlShehry","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed Ziauddin 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