Pivotal is providing its specialized clinical research services for the conduct of a clinical trial in patients with COVID-19
- The clinical trial, which plans to include a total of up to 300 patients, has recently begun to include the first patients in Madrid and will incorporate up to 25 European center
- The clinical trial will research whether treatment with hyperimmune plasma containing antibodies against the virus of patients who have already overcome the disease will benefit patients with COVID-19 acute phase without immunity against SARS-CoV-2
Pivotal, a European-wide full-service CRO, headquartered in Madrid, has announced today that it has been contracted to provide its specialized clinical research´s 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 who are admitted in an acute phase.
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 for the treatment of patients in the acute phase of this disease compared to 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 disease´s evolution and clinical results, as well as defining the primary objective to be used in the next phase; and, 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 illness.
“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 in this trial, the potential positive results which 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 challenge of this project which requires that the data is continuously uploaded and updated, given the context of hospital´s centers today and the adaptive design of the study, has been to design and implement in a few days a sufficiently robust information´s system to meet the strict international standards for clinical trials while also being agile and flexible so that it collects information immediately from donors and patients from all the involved centers and thus, be able to provide a daily access to safety reports to the Monitoring Committee to quickly implement the decisions that guarantee patients´ safety.”
The historical aggregated data to date in 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, in the context of a clinical trial in the initial phase of this disease in these patients, outweighs its potential risks.
Ms. Natalia Farr