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Research Article
A randomized open-label clinical trial to evaluate convalescent plasma compared to conventional standard care management for SARS-CoV-2 (COVID-19) in hospitalized patients in the Dominican Republic
1 Research Manager, Instituto Nacional de Investigaciones de Enfermedades Infecciosas (INIEICONT), Santo Domingo, Dominican Republic
2 Blood Bank Director, Hospital General de la Plaza de la Salud Santo Domingo, Dominican Republic
3 Research Director, Hospital General de la Plaza de la Salud Santo Domingo, Dominican Republic
4 Senior Medical Manager, Macopharma SAS Medical Affairs, Atlanta, GA, USA
5 Research Director of the Faculty of Health Sciences, Universidad Autonoma de Santo Domingo, Santo Domingo, Dominican Republic
6 Universidad Autonoma de Santo Domingo, Santo Domingo, Dominican Republic
Address correspondence to:
Angiolina Camilo Reynoso
MD, PhD, Instituto Nacional de Investigación de Enfermedades Infecto-Contagiosas (INIEICONT), C/Colon No. 2, Santa Bárbara, Santo Domingo, D.N.,
Dominican Republic
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Article ID: 100071Z02AC2022
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Reynoso AC, Sosa S, Mejia D, Frontier L, Diaz A, Montero R. A randomized open-label clinical trial to evaluate convalescent plasma compared to conventional standard care management for SARS-CoV-2 (COVID-19) in hospitalized patients in the Dominican Republic. Int J Blood Transfus Immunohematol 2022;12:100071Z02AC2022.ABSTRACT
Aims: The potential benefit of blood therapy in the pandemic is an opportunity for breakthrough therapy. Still, it is also a test for countries to understand their blood supply system and its regulatory infrastructure to succeed in a potentially life-saving alternative for emergent pandemics.
Methods: A multicenter, randomized, zero-phase exploratory study is to compare the efficacy and safety of Convalescent Plasma (CP, test group) with standard care therapy (control group) in hospitalized patients for SARS-CoV-2 (COVID-19).
Results: Thirty-five patients were randomized; 18 (51.4%) corresponded to the treated group. There was a clinical improvement over time for both groups (p < 0.001), but CP didn’t show a significantly different result than standard treatment for non-critically ill patients infected with COVID-19 in the Dominican Republic (p = 0.058). The appearance of dyspnea, the increase of >50% of pulmonary infiltrates between 24 and 48 hours of evolution, and positive qualitative polymerase chain reaction (PCR) results improved significantly in the control group. Therefore, convalescent therapy presented a significant recovery in these signs and symptoms. No adverse events were reported.
Conclusion: This prospective study serves as a pilot to propose an investigation with a representative sample to evaluate the benefits of this therapy’s effects in a bigger population. The most significant advantage of Convalescent Plasma (CP) therapy was obtained in the first six days, where the improvement in clinical categorization was faster, suggesting CP is best for early and mild cases of COVID-19. Actions for enrolling volunteers for this study were not productive, an opportunity for the Dominican Republic health authorities to improve their blood donation strategies and support blood availability.
Keywords: Convalescent plasma, COVID-19, SARS-CoV-2, Dominican Republic
SUPPORTING INFORMATION
Acknowledgments
This research was carried out thanks to funding from INIEICONT and UASD, supported by the Dominican Republic MSP and the HGPS. All authors, donors, and patients were volunteers in this research. Professor Guarionex Gomez (Statistics, UASD) and Dr. Ignacio Alvarez (Statistics-Madrid) contributed to the statistical analysis. Oskuary Jimenez and Luis Bido were from INIEICONT. Dr. Miguel Nuñez (Infectious Diseases, Dom. Rep.) was a scientific advisor.
Author ContributionsAngiolina Camilo Reynoso - Conception of the work, Design of the work, Acquisition of data, Drafting the work, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Socrates Sosa - Conception of the work, Design of the work, Analysis of data, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Dolores Mejia - Conception of the work, Design of the work, Acquisition of data, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Ludwig Frontier - Conception of the work, Design of the work, Analysis of data, Drafting the work, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Angel Diaz - Analysis of data, Drafting the work, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Rafael Montero - Analysis of data, Revising the work critically for important intellectual content, Final approval of the version to be published, Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Guarantor of SubmissionThe corresponding author is the guarantor of submission.
Source of SupportNone
Consent StatementWritten informed consent was obtained from the patient for publication of this article.
Data AvailabilityAll relevant data are within the paper and its Supporting Information files.
Conflict of InterestAuthors declare no conflict of interest.
Copyright© 2022 Angiolina Camilo Reynoso et al. This article is distributed under the terms of Creative Commons Attribution License which permits unrestricted use, distribution and reproduction in any medium provided the original author(s) and original publisher are properly credited. Please see the copyright policy on the journal website for more information.
