Author:
Santosa Damai,Sofro Muchlis Achsan Udji,Retnaningsih Retnaningsih,Pangarsa Eko Adhi,Setiawan Budi,Farhanah Nur,Kholis Fathur Nur,Handoyo Thomas,Rahardjo Sofyan,Nindhita Like Rahayu,Puspitasari Iva,Naibaho Ridho M.,Kharismasari Retty,Kartiyani Ika,Yunarvika Vina,Rizky Daniel,Suhartono Suhartono
Abstract
Introduction: The historical treatment of convalescent plasma was successful against RNA viruses. However, the significance of COVID-19 convalescent plasma therapy has not been clinically proven consistently in most studies and the available data showed contradictory results so far. Our study aims to evaluate the role of convalescent plasma therapy as an adjunctive treatment for severe and critically ill COVID-19 patients.Methods: This study was an open-label, non-randomized comparative clinical trial that was conducted at Dr. Kariadi Hospital, Semarang, Indonesia. This study sample are hospitalized severe and critically ill COVID-19 patients were assigned with a 2:1 ratio to receive convalescent plasma and local standard of care. The primary outcome was the clinical status 30 days after the interventionResults: A total of 73 patients received convalescent plasma and 38 patients received local standards of care. Both of the groups had similar clinical ordinal scales (median was 5, p=0.65), while patients in the study groups had significantly higher SOFA scores and P/F ratio. The control group had a worse overall mortality rate (61.1% vs 18.4%) with a hazard ratio of 3.5 (95%CI, 2.1-5.9) compared to the study group. From the subgroup analysis, we found that patients in the study group without mechanical ventilation support had the best survival rate compared to other groups HR: 0.0047 (95%CI, 0.01-0.19). The clinical outcome 7 days after convalescent plasma infusion was also significantly improved in the study group (median baseline & day-7, 5 & 3, p<0.001). From the multivariate analysis of therapeutic variables, convalescent plasma was the most significant variable for survival outcome (OR=0.089, 95%CI, 0.029-0.27; p<0.001). There was one case of anaphylactic shock and was excluded.Conclusions: The convalescent plasma administration significantly improved clinical outcomes and overall survival rates compared to those who received local standards of care.
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