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May 8, 2020updated 12 Jul 2022 11:48am

Pivotal to conduct clinical trial on Covid-19 patients

European full-service contract research organisation (CRO) Pivotal is providing specialised clinical research services for conducting a clinical study in patients suffering from coronavirus.

European full-service contract research organisation (CRO) Pivotal is providing specialised clinical research services for conducting a clinical study in patients suffering from coronavirus.

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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.

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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