Convalescent Plasma in COVID-19. Mortality-Safety First Results of the Prospective Multicenter FALP 001-2020 Trial
Journal of Vaccines and Vaccination(2020)
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 who were still within 14 days since symptom onset 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% vs. 11.5%; p = 0.037). Overall 30-day mortality was higher in patients over 65 than in younger patients (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.
Registration NCT04384588
### Competing Interest Statement
Dr. Nicolas Yanez reports personals fees from Merck and Pfizer. Dr. Christian Caglevic reports personals fees from Bristol Myers Squibb, MSD, Roche, Boehringer-Ingelheim and Andes Biotechnology, Lilly, Merck Sharpe and Dohme, Medivation, Astra Zeneca, and Astellas Pharma. All other authors have no conflict of interest.
### Clinical Trial
NCT04384588
### Clinical Protocols
### Funding Statement
Funding source: Fondo de Adopcion tecnologica SIEmpre supported by SOFOFA, Confederacion de la Produccion y de Comercio y Ministerio de Ciencia y Tecnologia, Conocimiento e Innovacion. Chile.
### Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
This project was developed and executed in accordance with Chilean Law No. 20,120 (On scientific research in the human being, its genome, and prohibitis human clonation : All scientific research on a human being must have his prior, express, free and informed consent, or, failing that, that of the person who must supply his will in accordance with the law.); Law No. 20,584 (Regulates the rights and duties that people have in relation to actions related to their health care); Law No. 19.628 (On protection of private life); CIOMS Guidelines, Declaration of Helsinki, Nuremberg code, The Universal Declaration of Human Rights and The International Covenant on Civil and Political Rights This protocol was approved by our local ethics committee: Comite Etico Cientifico Fundacion Arturo Lopez Perez, on April 7th, 2020. Informed consent was obtained from all patients or a representative when the patients were unable to sign themselves due to their health condition. A total of 41 patients from the [NCT04375098][1] trial were included in this report through a collaborative network.
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
We are unable to make the data available in a public repository or uploaded as supplementary information because this is not permitted by our organisation s research governance policy and ethics committee regulations. Anonymised data can be made available to researchers who meet the conditions of the ethics approval and research governance policy that applies to this study. Researchers may request anonymized data access by contacting Principal Investigator at raimundo.gazitua{at}falp.org
[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04375098&atom=%2Fmedrxiv%2Fearly%2F2020%2F12%2F02%2F2020.11.30.20218560.atom
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Key words
plasma,mortality-safety
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