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ORIGINAL ARTICLE
Year : 2021  |  Volume : 9  |  Issue : 1  |  Page : 16-23

Safety and Efficacy of Convalescent Plasma for Severe COVID-19: Interim Report of a Multicenter Phase II Study from Saudi Arabia


1 Department of Adult Hematology/BMT, King Fahad Medical City, Riyadh, Saudi Arabia
2 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
3 Department of Infection Control and Prevention, Prince Sultan Military Medical City, Riyadh, Saudi Arabia
4 Department of Infectious Diseases, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
5 Department of Hematology and Oncology, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia
6 Department of Pediatrics, King Saud University, Riyadh, Saudi Arabia
7 Department of Medicine, King Fahad General Hospital, Madinah, Saudi Arabia
8 Department of Epidemiology and Biostatistics, King Fahad Specialist Hospital, Dammam, Saudi Arabia
9 Department of Medicine, College of Medicine, Alfaisal University; Department of Medical Specialties, King Fahad Medical City; Research Center, Dr. Sulaiman Al Habib Medical Group, Riyadh, Saudi Arabia
10 Department of Hematology and Stem Cell Transplantation, King Fahad Specialist Hospital, Dammam, Saudi Arabia
11 Department of Emergency and Critical Care, College of Medicine, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, Al Khobar, Saudi Arabia
12 Department of Blood Bank, College of Medicine; Division of Hematology, Department of Pathology, King Saud University, Riyadh, Saudi Arabia
13 Department of Infectious Diseases, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia
14 Department of Medicine, International Medical Center, Jeddah, Saudi Arabia
15 Hematology Laboratory Section of Medical Laboratory Department, Qatif Central Hospital, Qatif, Saudi Arabia
16 Department of Hematology, King Abdullah Medical Complex, Jeddah, Saudi Arabia
17 Division of Hematology, Department of Medicine, King Fahd Military Medical Complex, Dhahran, Saudi Arabia
18 Department of Hematopathology, King Fahad Specialist Hospital, Dammam, Saudi Arabia
19 Division of Hematology, Department of Pathology, King Saud University; Oncology Center, King Saud University Medical City, Riyadh, Saudi Arabia
20 Department of Transfusion Medicine and Stem Cell Processing, King Fahad Specialist Hospital, Dammam, Saudi Arabia
21 Department of Internal Medicine, College of Medicine, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, Al Khobar, Saudi Arabia
22 Department of Hematology and Bone Marrow Transplantation, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
23 Department of Infectious Diseases, King Abdullah Medical City, Makkah, Saudi Arabia
24 Department of Infectious Diseases, Asir Central Hospital, Abha, Saudi Arabia
25 Department of Internal Medicine, Taibah University, Madinah, Saudi Arabia
26 Department of Critical Care, Dammam Medical Complex, Dammam, Saudi Arabia
27 Department of Pathology and Laboratory Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

Correspondence Address:
Dr. Hani Al-Hashmi
Department of Hematology and Stem Cell Transplantation, King Fahad Specialist Hospital, Amr Bin Thabet Street, Dammam 31444
Saudi Arabia
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DOI: 10.4103/sjmms.sjmms_731_20

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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; SpO2, ≤93%, PaO2/FiO2 ratio, <300; and/or lung infiltrates >50% within 24–48 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. 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.


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