This study is a multicenter, randomized, sequential and adaptive design clinical trial that will use the plasma extracted from around 200 convalescent patients with COVID-19 to treat patients in the acute phase of this disease compared with standard treatment. The trial will be carried out in two phases:
- A pilot phase of up to 100 patients to evaluate the safety of the procedure and obtain more precise parameters on the characteristics of these patients, the markers of the disease´s evolution and clinical results, as well as defining the primary objective to be used in the next phase.
- A pivotal phase with up to 200 additional patients to evaluate the efficacy and safety of using plasma from COVID-19 convalescent patients, compared to standard treatment, in the treatment of hospitalized patients with acute phase of COVID-19.
"The know-how and excellence in clinical research of the clinical investigators´ teams, together with Pivotal's vast experience in research methodology in clinical trials, will allow us to accelerate the research and to test this new treatment regimen. The potential positive results could provide a therapeutic tool available to all hospitals to significantly reduce COVID-19´s mortality," said Dr. José Javier García, M.D., vice president of Data Management and Biostatistics at Pivotal. “The challenge of this project is that the data is continuously uploaded and updated. Given the context of hospital centers today and the adaptive design of the study, we have had to design and implement a sufficiently robust information system in a few days to meet the strict international standards for clinical trials while also being agile and flexible enough that it collects information immediately from donors and patients from all the involved centers and thus, is able to provide daily access to safety reports to the Monitoring Committee to quickly implement the decisions that guarantee patient safety.”
The historical aggregated data to date for COVID-19 and other diseases caused by coronavirus suggest that hyperimmune plasma´s transfusion to hospitalized patients with COVID-19 is safe, and that, due to the severity and high mortality of this disease and the potential advantages of hyperimmune plasma transfusion use, a clinical trial in the initial phase of this disease in these patients outweighs its potential risks.