Safety and Efficacy of Convalescent Plasma for Severe COVID-19: Interim Report of a Multicenter Phase II Study from Saudi Arabia.
| Autor: | AlShehry N; Department of Adult Hematology/BMT and, King Fahad Medical City, Riyadh, Saudi Arabia., Zaidi SZA; Department of Adult Hematology/BMT and, King Fahad Medical City, Riyadh, Saudi Arabia., AlAskar A; King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Ministry of National Guard - Heath Affairs, Riyadh, Saudi Arabia., Al Odayani A; Department of Infection Control and Prevention, Prince Sultan Military Medical City, Riyadh, Saudi Arabia., Alotaibi JM; Department of Infectious Diseases, Riyadh, Saudi Arabia., AlSagheir A; Department of Hematology and Oncology, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia., Al-Eyadhy A; Department of Pediatrics, College of Medicine, Riyadh, Saudi Arabia., Balelah S; Department of Medicine, King Fahad General Hospital, Madinah, Saudi Arabia., Salam A; Department of Epidemiology and Biostatistics, King Fahad General Hospital, Dammam, Saudi Arabia., Zaidi ARZ; Department of Medicine, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.; Medical Specialties, King Fahad Medical City, Riyadh, Saudi Arabia.; Research Center, Dr. Sulaiman Al Habib Medical Group, Riyadh, Saudi Arabia., Alawami D; Department of Hematology and Stem Cell Transplantation, King Fahad Specialist Hospital, Dammam, Saudi Arabia., Alshahrani MS; Department of Emergency and Critical Care, College of Medicine, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, Al Khobar, Saudi Arabia., AlMozain N; Department of Blood Bank, College of Medicine, King Saud University, Riyadh, Saudi Arabia.; Division of Hematology, Department of Pathology, King Saud University, Riyadh, Saudi Arabia., Abulhamayel YM; Department of Infectious Diseases, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia., Al Qunfoidi R; Department of Medicine, International Medical Center, Jeddah, Saudi Arabia., Alfaraj M; Hematology Laboratory Section of Medical Laboratory Department, Qatif Central Hospital, Qatif, Saudi Arabia., Qushmaq N; Department of Hematology, King Abdullah Medical Complex, Jeddah, Saudi Arabia., Alansari R; Division of Hematology, Department of Medicine, King Fahd Military Medical Complex, Dhahran, Saudi Arabia., Dayel A; Department of Hematopathology, King Fahad Specialist Hospital, Dammam, Saudi Arabia., Elgohary G; Division of Hematology, Department of Pathology, King Saud University, Riyadh, Saudi Arabia.; Oncology Center, King Saud University Medical City, Riyadh, Saudi Arabia., Al Bahrani A; Department of Transfusion Medicine and Stem Cell Processing, King Fahad Specialist Hospital, Dammam, Saudi Arabia., Nabhan Abdelhameed AA; Internal Medicine, College of Medicine, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, Al Khobar, Saudi Arabia., AlZahrani HA; Department of Hematology and Bone Marrow Transplantation, Riyadh, Saudi Arabia., Alturkistani H; Department of Infectious Diseases, King Abdullah Medical City, Makkah, Saudi Arabia., AlShehry N; Department of Infectious Diseases, Asir Central Hospital, Abha, Saudi Arabia., Albalawi MA; Department of Internal Medicine, Taibah University, Madinah, Saudi Arabia., Elalfy I; Department of Critical Care, Dammam Medical Complex, Dammam, Saudi Arabia., Alhumaidan H; Pathology and Laboratory Medicine King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia., Al-Hashmi H; Department of Hematology and Stem Cell Transplantation, King Fahad Specialist Hospital, Dammam, Saudi Arabia. |
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| Jazyk: | angličtina |
| Zdroj: | Saudi journal of medicine & medical sciences [Saudi J Med Med Sci] 2021 Jan-Apr; Vol. 9 (1), pp. 16-23. Date of Electronic Publication: 2020 Dec 26. |
| DOI: | 10.4103/sjmms.sjmms_731_20 |
| Abstrakt: | Objective: 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). Trial Design and Participants: An open label, two-arm, phase-II clinical trial conducted across 22 hospitals from Saudi Arabia. The intervention group included 40 adults (aged ≥18 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, ≥30/min; SpO Interventions: The intervention group participants were infused 300 ml (200-400 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. Outcomes: 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. Results: 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 ( P = 0.147), hazard ratio (95% confidence interval): 0.554 (0.299-1.027; P = 0.061) by log-rank test. There was no significant difference in the days on mechanical ventilation and days to clinical recovery. Conclusion: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT04347681; Saudi Clinical Trials Registry No.: 20041102. Competing Interests: There are no conflicts of interest. (Copyright: © 2020 Saudi Journal of Medicine & Medical Sciences.) |
| Databáze: | MEDLINE |
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