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a European clinical trial of four experimental treatments is underway

Coordinated by Inserm, from Lyon, a large European clinical trial began this Sunday. He will evaluate four experimental treatments against Covid-19. This trial will include at least 800 French patients suffering from severe forms of Covid-19 and will quickly involve around twenty establishments.

A clinical Review, baptized Discovery and coordinated by Inserm as part of the Reacting consortium, starts this weekend in France to Review four experimental treatments against the Covid-19. This is a European project (supported by the Combacte, Prepare and Recover projects), the French part of which is funded by the Ministries of Higher Education, Research and Innovation (MESRI) and of Health and of Solidarities (MSS).

It is led by Florence Ader, infectious disease specialist in the infectious and tropical diseases department at the Croix-Rousse hospital at the CHU in Lyon and researcher at the International Center for Research in Infectious Disease Ciri (Inserm, CNRS, University Claude Bernard Lyon 1).

The strength of an adaptive essay

The objective is to assess the efficacy and safety of four experimental therapeutic strategies that could have an effect against Covid-19 at look current scientific data. " We analyzed data from the scientific literature concerning coronavirus SARS and MERS as well as the first publications on the SARS-CoV-2 from China to come up with a list of antiviral molecules to Review: remdesivir, lopinavir in combination with ritonavir, the latter treatment being associated or not withinterferon beta, and hydroxychloroquine. The list of these potential drugs is also based on the list of treatments classified as priority by theWorld Health Organization ", explains Florence Ader.

The Discovery trial begins with five treatment methods: standard care; standard care plus remdesivir; standard care plus lopinavir and ritonavir; standard care plus lopinavir, ritonavir and beta interferon; standard care plus hydroxy-chloroquine.

The allocation of treatment modalities will be done randomly, i.e. randomly, but patients and doctors will know which treatment is used (this is known as an open trial). The analysis of the efficacy and safety of the treatment will be evaluated 15 days after the inclusion of each patient.

"The great strength of this essay is its character "adaptive". This means that very quickly ineffective experimental treatments can be abandoned and replaced by other molecules that emerge from research. We will therefore be able to react in real time, consistent with the most recent scientific data, in order to highlight the best treatment for our patients. “Continues Florence Ader.

At least 800 French patients will participate in the trial

It is planned to include 3,200 European patients including Belgium, the Netherlands, Luxembourg, the United Kingdom, Germany and Spain, and possibly other countries including at least 800 in France, hospitalized for a infection Covid-19 in a medical service or directly in resuscitation. " Five French hospitals will participate at the start (Paris – Bichat-AP-HP hospital, Lille, Nantes, Strasbourg, Lyon) then, we will open other centers to reach at least twenty participating establishments. Our center opening strategy will follow the epidemiological reality ofepidemic with prioritization at the start of the trial in hospitals under strong pressure " Recruitment starts today.

" This essay is designed in a pragmatic and adaptive way. Its purpose is to analyze the efficacy and tolerance of the therapeutic options for patients in a limited time. It is a resolutely proactive research approach against the disease ", She concludes.

This trial will also complement the data that will be collected during another international clinical trial which will soon start under the aegis of the World Health Organization, dubbed " Solidarity "

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