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Convalescent Plasma in COVID-19; Mortality-Safety First Results Of ccines & a V f V a OPEN ACCESS Freely available online o c l c i a n n a r t u i o o n J ISSN: 2157-7560 Journal of Vaccines & Vaccination Research Article Convalescent Plasma in COVID-19; Mortality-Safety First Results of the Prospective Multicenter FALP 001-2020 Trial Raimundo Gazitua1*, Jose Luis Briones1, Carolina Selman2, Franz Villarroel-Espíndola3, Adam Aguirre-Ducler3, Roxana Gonzalez-Steigmaier3, Karina Cereceda3, Mauricio Mahave4, Ricardo Morales5, Fernanda Yarad5, Nicolas Yannez6, María Elvira Balcells7, Luis Rojas7, Bruno Nervi8, Jyh Kae Nien9, Javier Garate10, Carolina Prieto11, Sofía Palma11, Carolina Escobar11, Josefina Bascuñán12, Rodrigo Muñoz13, Mónica Pinto13, Daniela Cardemil13, Marcelo Navarrete14, Soledad Reyes15, Victoria Espinosa15, Betzabé Rubio16, Pedro Ferrer-Rosende16, Jorge Sapunar16, Hugo Marsiglia16, Christian Caglevic16 1Department of Hematology, Arturo López Pérez Foundation Oncological Institute, Santiago, Metropolitan Region, Chile;2Department Diagnostic, Arturo López Pérez Foundation Oncological Institute, Santiago, Metropolitan Region, Chile;3Translational Medicine Research Laboratory, Arturo López Pérez Foundation, Santiago, Metropolitan Region, Chile;4Department of Medical Oncology, Arturo López Pérez Foundation Oncological Institute, Santiago, Metropolitan Region, Chile;5Department of Internal Medicine, Arturo López Pérez Foundation Oncological Institute, Santiago, Metropolitan Region, Chile;6Department of Medical Oncology, Regional Hospital of Talca, Maule Region, Chile;7Department of Infectious Diseases, School of Medicine, Pontifical Catholic University of Chile, Santiago, Metropolitan Region, Chile;8Department of Hematology and Oncology, School of Medicine, Pontifical Catholic University of Chile, Santiago, Metropolitan Region, Chile;9Dávila Clinic, Santiago, Metropolitan Region, Chile;10Red Salud Clinic, Santiago, Metropolitan Region, Chile;11Dipreca Hospital, Santiago, Metropolitan Region, Chile;12Hospital del Trabajador, Chilean Security Association, Santiago, Metropolitan Region, Chile;13Department of Infectious Diseases, Magallanes Clinical Hospital, Punta Arenas, Magallanes and Chilean Antarctic Region, Chile;14School of Medicine, University of Magallanes, Punta Arenas, Magallanes and Chilean Antarctic Region, Chile;15Clínica Alemana Temuco, Araucanía Region, Chile;16Department of Cancer Research, Oncological Institute Arturo López Pérez Foundation, Santiago, Metropolitan Region, Chile ABSTRACT Background: The use of Convalescent Plasma (CP) to treat COVID-19 has shown promising results; however, its effectiveness remains uncertain. The purpose of this study was to determine the safety and mortality of CP among patients hospitalized with COVID-19. Study design and methods: This multicenter, open-label, uncontrolled clinical trial is currently being conducted at nine hospitals in Chile. Patients hospitalized due to COVID-19 with less than 14 days since symptom onset were eligible. Enrolled patients were classified into four groups: Patients with cancer and severe COVID-19. Patients with cancer and non-severe COVID-19. Patients with severe COVID-19 and patients with non-severe COVID-19 only. The intervention involved two 200-cc. CP transfusions with anti-SARS-CoV-2 IgG titers ≥ 1:320 collected from COVID-19-recovered donors. Results: 192 patients hospitalized for COVID-19 received CP transfusions. At the first transfusion, 90.6% fulfilled the criteria for severity, and 41.1% required mechanical ventilation. 11.5% of the patients had cancer. Overall, 7-day and 30-day mortality since the first CP transfusion was 5.7% and 16.1% respectively. There were no differences at either time point in mortality between the four groups. Patients on mechanical ventilation when receiving CP had higher mortality rates than those who were not: 22.8% (95% C.I. 14.1-33.6%) vs. 11.5% (95% C.I. 6.3–18.9%) (p=0.037). Overall, 30-day mortality was higher in patients over 65 than in younger patients: 26.7% (95% C.I. 16.1– 39.7%) (p=0.019). Severe adverse events were reported in four patients (2.1%) with an overall transfusion-related lung injury rate of 1.56%. No CP-related deaths occurred. Discussion: CP is safe when used in patients with COVID-19 even when also presenting severity criteria or risk factors. Our mortality rate is comparable to reports from larger studies. Controlled clinical trials are required to determine efficacy. Conclusion: CP is safe when used in the COVID-19 population even for those who present severity criteria and/or risk factors for poor prognosis including cancer. In-depth analyses of the serological and molecular characteristics of CP are needed to evaluate the efficacy of this intervention through controlled clinical trials. Registration: NCT04384588 Keywords: COVID-19; Vaccine; Convalescent plasma; Diagnosis Correspondence to: Raimundo Gazitua, Department of Hematology, Arturo López Pérez Foundation Oncological Institute, Santiago, Metropolitan Region, Chile, Tel: +56-9-84290128; Email: [email protected] Received: March 10, 2021; Accepted: March 25, 2021; Published: April 01, 2021 Citation: Gazitua R, Briones JL, Selman C, Villarroel-Espíndola F, Aguirre-Ducler A, Gonzalez-Steigmaier R, et al. (2021) Convalescent Plasma in COVID-19; Mortality-Safety First Results of the Prospective Multicenter FALP 001-2020 Trial. J Vaccines Vaccin. S12: 002. Copyright: © 2021 Gazitua R, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. J Vaccines Vaccin, Vol. S12 No: 1000002 1 Gazitua R, et al. OPEN ACCESS Freely available online INTRODUCTION This project was developed and executed in accordance with Chilean Law No. 20.120 (“On scientific research in the human being, its Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) genome, and prohibits human clonation” : All scientific research was first described in December 2019 in Wuhan, China and quickly on a human being must have his prior, express, free and informed spread across the globe, being declared a pandemic by the World consent, or, failing that, that of the person who must supply his Health Organization (WHO) on March 11, 2020 [1]. The first will in accordance with the law."); Law No. 20,584 ("Regulates the case in South America was reported on February 26 in Brazil [2], rights and duties that people have in relation to actions related while in Chile, the index case was confirmed on March 3, 2020 [3]. to their health care”); Law No. 19.628 ("On protection of private Currently, 29% of the cases worldwide are concentrated in Latin life”); CIOMS Guidelines, Declaration of Helsinki, Nuremberg America, one of the most affected areas in the world [2], which code, The Universal Declaration of Human Rights and The constitutes a serious health problem considering the complex International Covenant on Civil and Political Rights. socioeconomic and health characteristics of this region. At the time of study start, there was neither a completely effective Ethics standard of care nor a proven effective vaccine against COVID-19. The study was approved by our local ethics committee: Comité Many therapies have been evaluated against SARS-CoV-2 with Ético Científico Fundación Arturo López Pérez, on April 7th, mixed results. The combination of hydroxychloroquine and 2020. Informed consent was obtained from all participants by an azithromycin in an early case series seemed promising [4], but authorized delegate in each participating center as follows: randomized studies were unable to confirm its efficacy, and had Donors an even higher incidence of adverse effects [5-7]. The antiviral drug remdesivir provides clinical improvement yet no decrease in Written informed consent was provided by all the participating mortality [8,9]. Moreover, antiviral drugs lopinavir/ritonavir were donors. Consent by a legal representative was not needed. also shown to be ineffective against SARS CoV-2 [10]. Only low All plasma units were fully anonymized following the guidelines doses of dexamethasone decrease the mortality rate in patients with established in local Blood Banks before being accessed by the mechanical ventilation and oxygen supplementation requirements research team [11]. Plasma recipient Passive immunotherapy with Convalescent Plasma (CP) from individuals who have already recovered from infection has been All plasma recipients or the corresponding legal representative safe and effective against previous viral outbreaks including the provided written informed consent as authorized by the SARS-CoV-1, MERS-CoV, influenza A (H1N1), and the Ebola corresponding Ethics Committee. Remote informed consent virus epidemics [12-17]. The initial reports published on using CP was authorized by the Local Ethics Committee when legal to treat COVID-19 suggest that it confers clinical improvement, representatives were unable to physically attend. The remote decreases viral load, and shortens mechanical ventilation duration consent was obtained by a video/phone call followed by digital [18,19]. The use of CP is safe, with an incidence of related serious transfer of the signed form. adverse events of less than 1% of treated patients, similar to the This study did not include underage participants. usual practice of transfusion medicine [20]. Patients were enrolled between May 2020 and August 2020. In this work, we report on the safety and in-hospital mortality
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