Pivotal to Support Hyperimmune COVID-19 Plasma Trial

Pivotal, a European CRO, has been contracted to provide specialized clinical research services in a clinical trial to study the efficacy and safety of hyperimmune plasma, obtained from cured and convalescent COVID-19 patients, in the treatment of hospitalized patients with COVID-19.

This study will use the plasma extracted from approximately 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 will 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 will evaluate the efficacy and safety of using plasma from COVID-19 convalescent patients, compared to standard treatment, in 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,” says Dr. José Javier García, MD, Vice President of Data Management and Biostatistics at Pivotal.

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.