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European full-service contract research organisation (CRO) Pivotal is providing specialised clinical research services for conducting a clinical study in patients suffering from coronavirus.
The clinical trial intends to include up to 300 patients in up to 25 European centres. It has begun with first patients in Madrid.
According to Pivotal, the trial will study whether the treatment against the virus with hyperimmune plasma containing antibodies in patients, who have already recovered from the virus, will stand to benefit those patients with Covid-19 acute phase without immunity against SARS-CoV-2.
The trial is designed to be a multicentre, randomised, sequential and adaptive study that will use the plasma extracted from about 200 convalescent Covid-19 patients for the treatment of patients suffering with the acute phase of this disease, compared to standard treatment.
It will be carried out in two phases.
A pilot phase will involve the participation of 100 patients to evaluate the safety of the procedure, as well as obtain more precise parameters on the characteristics of these patients. Disease´s evolution and clinical results, and also defining the primary objective to be used in the next phase will be carried out in this phase.
The second phase, which is a pivotal phase and involving up to 200 additional patients, will evaluate the safety and efficiency of using plasma from Covid-19 convalescent patients.
Pivotal Data Management and Biostatistics vice-president José Javier García said: “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.”
Last July, Pivotal announced to support two Phase II clinical trials of a new immunotherapy drug in metastatic melanoma (MM) and non-small cell lung cancer (NSCLC) patients.