Safety and Efficacy of Convalescent Plasma to Treat Severe COVID-19: Protocol for the Saudi Collaborative Multicenter Phase II Study.

Autor:	Albalawi M; Department of Internal Medicine, College of Medicine, Taibah University, Madinah, Saudi Arabia., Zaidi SZA; Department of Adult Hematology/Blood & Marrow Transplant, King Fahad Medical City, Riyadh, Saudi Arabia., AlShehry N; Department of Adult Hematology/Blood & Marrow Transplant, 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, Riyadh, Saudi Arabia., Zaidi ARZ; Department of Medicine, King Fahad Medical City, Riyadh, Saudi Arabia., Abdallah RNM; Department of Pulmonary and Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi Arabia., Salam A; Department of Epidemiology and Biostatistics, King Fahad Specialist Hospital, Dammam, Saudi Arabia., AlSagheir A; Department of Hematology and Oncology, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia., AlMozain N; Department of Blood Bank, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia., Elgohary G; Oncology Center, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia., Batarfi K; Transfusion Medicine Services, Department of Pathology & Laboratory Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia., Alfaraedi A; King Saud University, Riyadh, Saudi Arabia., Khojah O; King Saud University, Riyadh, Saudi Arabia., Al-Ansari R; Department of Medicine, King Fahad Military Medical Complex, Dhahran, Saudi Arabia., Alfaraj M; Hematology Laboratory Section of Medical Laboratory Department, Qatif Central Hospital, Qatif, Saudi Arabia., Dayel A; Department of Hematopathology, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia., Al Bahrani A; Department of Transfusion Medicine and Stem Cell Processing, King Fahad Specialist Hospital, Dammam, Saudi Arabia., Abdelhameed AN; Department of Internal Medicine, Imam Abdulrahman Bin Faisal University, Al-Khobar, Saudi Arabia., Alhumaidan H; Department of Pathology and Laboratory Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia., Al-Otaibi JM; Department of Infectious Diseases, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia., Radwi G; Department of Hematology, University of Alberta, Edmonton, ON, Canada., Raizah A; King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia., Shatry H; King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia., Alsaleh S; Department of Hematology and Oncology, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia., AlZahrani H; Department of Hematology and Bone Marrow Transplantation Section, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia., Al-Hashmi H; Adult Hematology & Stem Cell Transplantation Department, Oncology Centre, King Fahad Specialist Hospital, Dammam, Saudi Arabia.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2020 Oct 02; Vol. 9 (10), pp. e23543. Date of Electronic Publication: 2020 Oct 02.
DOI:	10.2196/23543
Abstrakt:	Background: The COVID-19 pandemic is expected to cause significant morbidity and mortality. The development of an effective vaccine will take several months to become available, and its affordability is unpredictable. Transfusion of convalescent plasma (CP) may provide passive immunity. Based on initial data from China, a group of hematologists, infectious disease specialists, and intensivists drafted this protocol in March 2020. Objective: The aim of this study is to test the feasibility, safety, and efficacy of CP in treating patients with COVID-19 across Saudi Arabia. Methods: Eligible patients with COVID-19 will be recruited for CP infusion according to the inclusion criteria. As COVID-19 has proven to be a moving target as far as its management is concerned, we will use current definitions according to the Ministry of Health (MOH) guidelines for diagnosis, treatment, and recovery. All CP recipients will receive supportive management including all available recommended therapies according to the available MOH guidelines. Eligible CP donors will be patients with COVID-19 who have fully recovered from their disease according to MOH recovery criteria as detailed in the inclusion criteria. CP donors have to qualify as blood donors according to MOH regulations except for the history of COVID-19 in the recent past. We will also test the CP donors for the presence of SARS-CoV-2 antibodies by a rapid test, and aliquots will be archived for future antibody titration. Due to the perceived benefit of CP, randomization was not considered. However, we will compare the outcome of the cohort treated with CP with those who did not receive CP due to a lack of consent or lack of availability. In this national collaborative study, there is a likelihood of not finding exactly matched control group patients. Hence, we plan to perform a propensity score matching of the CP recipients with the comparator group patients for the major characteristics. We plan to collect demographic, clinical, and laboratory characteristics of both groups and compare the outcomes. A total sample size of 575 patients, 115 CP recipients and 460 matched controls (1:4 ratio), will be sufficient to detect a clinically important hospital stay and 30-day mortality difference between the two groups with 80% power and a 5% level of significance. Results: At present, patient recruitment is still ongoing, and the interim analysis of the first 40 patients will be shared soon. Conclusions: In this paper, we present a protocol for a national collaborative multicenter phase II study in Saudi Arabia for assessing the feasibility, safety, and potential efficacy of CP in treating patients with severe COVID-19. We plan to publish an interim report of the first 40 CP recipients and their matched comparators soon. Trial Registration: ClinicalTrials.gov NCT04347681; https://clinicaltrials.gov/ct2/show/NCT04347681. International Registered Report Identifier (irrid): PRR1-10.2196/23543. (©Mohammed Albalawi, Syed Ziauddin Ahmed Zaidi, Nawal AlShehry, Ahmed AlAskar, Abdul Rehman Zia Zaidi, Rania Nagib Mohammed Abdallah, Abdul Salam, Ahmed AlSagheir, Nour AlMozain, Ghada Elgohary, Khalid Batarfi, Alia Alfaraedi, Osamah Khojah, Rehab Al-Ansari, Mona Alfaraj, Afra Dayel, Ahmed Al Bahrani, Arwa Nabhan Abdelhameed, Hind Alhumaidan, Jawaher M Al-Otaibi, Ghazala Radwi, Abdulrahman Raizah, Hind Shatry, Sara Alsaleh, Hazzaa AlZahrani, Hani Al-Hashmi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.10.2020.)
Databáze:	MEDLINE
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