The AEMPS is working on different avenues of clinical research for the treatment of COVID-19
Two trials of remdesivir for patients with moderate or severe disease have begun at three health centers, with another five to be added in the coming days.
Another clinical trial has been started, promoted by the FLS Foundation, focused on confirmed non-serious cases of COVID-19 and chemoprophylaxis of risky contacts.
The approval of a WHO clinical trial protocol to extract relevant information from the practice that is being carried out in health centers is being finalized.
THE AEMPS makes itself available to promoters and researchers to offer scientific and regulatory advice in order to accelerate research in this area.
The emergence of a new disease such as COVID-19 is a challenge from the therapeutic point of view because it requires the development of treatment strategies based on robust evidence, but starting practically from scratch and while living with a growing number of cases every day in which decisions have to be made with the treatments that are available.
At this point, clinical research plays a fundamental role and it is necessary to articulate it in a flexible and pragmatic way, but at the same time that robust and interpretable evidence is generated that allows defining which new drugs or which new uses of drugs already authorized are effective and safe for COVID-19.
The Spanish Agency for Medicines and Health Products (AEMPS) works with the European Medicines Agency (EMA), the rest of the national agencies of the European Union, the World Health Organization (WHO) and the rest of the world agencies work to generate study protocols applicable in this situation of overload of the health system, but at the same time capable of generating evidence.
In relation to clinical trials of new drugs, the AEMPS has authorized two clinical trials with a new molecule called remdesivir for patients with disease moderate o reaction in which three Spanish centers participate, with five more to join shortly.
The AEMPS has also authorized a trial, promoted by the FLS Foundation for the fight against AIDS, infectious diseases and the promotion of health and science, for the treatment of confirmed non-serious cases of COVID-19 and chemoprophylaxis of their contacts as a prevention strategy.
In addition, the AEMPS works with the WHO in a protocol that can cover a multitude of authorized drug uses but not in the authorized indications such as Lopinavir / Ritonavir, chloroquine, hydroxychloroquine, among others, in addition to the aforementioned remdesivir as compassionate use. This protocol is being finalized these days and it is expected that a significant number of centers in Spain will participate. These types of protocols, called pragmatic, try to extract relevant information from routine practice and sacrifice part of their robustness for the sake of their feasibility, which is enormously important at times of high saturation of healthcare professionals who are treating patients in the centers.
The AEMPS maintains contacts with other potential commercial and non-commercial promoters in Spain and around the world both to authorize clinical trials of new molecules and to evaluate new uses of already authorized drugs. The AEMPS has made available the resources to evaluate these trials -also all kinds of observational study within the scope of its competences- in very short terms and makes itself available to all kinds of promoters to offer scientific and regulatory advice. It is intended to channel the efforts of all and join them in clinical trials with multiple arms of different treatments while allowing the generation of evidence. For this, it is made available to researchers and promoters through any of the email addresses of the Office of Innovation (innov_spain@aemps.es), from the scientific advisory area (ascina@aemps.es) or the clinical trials area (aecaem@aemps.es).
