Madrid (Spain), 28 April 2020 – Pivotal, a European-wide full-service CRO, has announced today that it has been contracted to provide specialised 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 hospitalised patients with COVID-19 who are admitted in an acute phase.
This study is a multicentre, randomised, 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 hospitalised 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 challenge of this project is that the data is continuously uploaded and updated. Given the context of hospital centres 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 centres 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 hospitalised 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.
Pivotal was founded in 2001 by Dr. Ibrahim Farr on the principle that strategic medical advice and support should be the backbone of all clinical trials. After working for over two decades in the pharmaceutical industry, Dr. Farr recognised the need for a medium-sized CRO with a solid internal medical franchise that could act not only as the "doers" but also as the “co-thinkers” for their clients, through its strategic scientific advice. To date, we are the trusted adviser and counsellor for many companies to deliver maximum value in their drug and medical devices development programs. We are a leading privately held European CRO and, since inception, we have experienced a fast and steady organic growth in Europe.
Pivotal´s client portfolio spans major pharmaceutical, biotechnological, medical device and nutrition companies, as well as independent investigators and cooperative groups. We have long-standing relations with over 200 clients. Pivotal has extensive experience across major therapeutic areas and phases I to IV. Our highly customised teams bring to each client a combination of broad industry knowledge and operational excellence, to offer our clients fresh perspectives and breakthrough business insights. Additionally, we have built a strong oncology, innovative therapies, rare diseases and early phases hub that enables us to tackle our customers' most difficult challenges, turning recommendations into concrete actions. By remaining true to our core principles and values, our vision is to become our clients' preferred outsourcing solution partner.
For more information, please visit http://www.pivotal.es