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

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.