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

Nawal AlShehry; Syed Ziauddin A Zaidi; Ahmed AlAskar; Abdurahman Al Odayani; Jawaher Mubarak Alotaibi; Ahmed AlSagheir; Ayman Al-Eyadhy; Saud Balelah; Abdul Salam; Abdul Rehman Zia Zaidi; Diea Alawami; Mohammed S Alshahrani; Nour AlMozain; Yem M Abulhamayel; Reem Al Qunfoidi; Mona Alfaraj; Nahid Qushmaq; Rehab Alansari; Afra Dayel; Ghada Elgohary; Ahmed Al Bahrani; Arwa A Nabhan Abdelhameed; Hazza Abdullah AlZahrani; Hanan Alturkistani; Nada AlShehry; Mohammed Abdulhameed Albalawi; Ibrahim Elalfy; Hind Alhumaidan; Hani Al-Hashmi

doi:10.4103/sjmms.sjmms_731_20

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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 Nawal AlShehry¹, Syed Ziauddin A Zaidi¹, Ahmed AlAskar², Abdurahman Al Odayani³, Jawaher Mubarak Alotaibi⁴, Ahmed AlSagheir⁵, Ayman Al-Eyadhy⁶, Saud Balelah⁷, Abdul Salam⁸, Abdul Rehman Zia Zaidi⁹, Diea Alawami¹⁰, Mohammed S Alshahrani¹¹, Nour AlMozain¹², Yem M Abulhamayel¹³, Reem Al Qunfoidi¹⁴, Mona Alfaraj¹⁵, Nahid Qushmaq¹⁶, Rehab Alansari¹⁷, Afra Dayel¹⁸, Ghada Elgohary¹⁹, Ahmed Al Bahrani²⁰, Arwa A Nabhan Abdelhameed²¹, Hazza Abdullah AlZahrani²², Hanan Alturkistani²³, Nada AlShehry²⁴, Mohammed Abdulhameed Albalawi²⁵, Ibrahim Elalfy²⁶, Hind Alhumaidan²⁷, Hani Al-Hashmi¹⁰ 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 DOI: 10.4103/sjmms.sjmms_731_20

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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