Coronavirus: Clinical trial piloted in Lyon, what should be remembered?

This is a real-time research project that has mobilized many researchers night and day since March 1. Sunday was launched Discovery, a European clinical trial piloted in Lyon and intended to evaluate different molecules to fight against the coronavirus.

So what do we need to know about this large-scale project detailed by Florence Ader, professor of infectious diseases at the CHU de Lyon, in charge of recruiting patients for this trial, and Bruno Lina, Lyon virologist and member of the committee scientist who surrounds Emmanuel Macron to manage the coronavirus crisis.

This is a real-time research project that has mobilized many researchers night and day since March 1. Sunday was launched Discovery, a European clinical trial piloted in Lyon and intended to evaluate different molecules to fight against the coronavirus. So, what do you need to know about this large-scale project detailed by Florence Ader, professor of infectious diseases at the CHU de Lyon, in charge of recruiting patients for this trial, and Bruno Lina, Lyon virologist and member of the scientific committee which surrounds Emmanuel Macron to manage the coronavirus crisis.

What to expect from such a test in the midst of a health crisis?

This research project, coordinated by Inserm as part of the European Reacting consortium, was set up in just a few weeks thanks to the mobilization of researchers and specialists in infectious diseases.

“It is an absolute feat to have successfully mounted a project of this magnitude. Inserm has done an extraordinary job, ”

Florence Ader

underlines Florence Ader, who is piloting this clinical trial intended to bring out one or more treatments that are effective against the coronavirus and tolerated by patients.

The objective is to make patients benefit from it as quickly as possible on a larger scale if one of the molecules evaluated shows its superiority in the therapeutic scheme.

Which molecules are evaluated?

Four therapeutic treatments will be studied. This is remdesivir, “an antiviral designed to fight the Ebola virus, but which has a broader spectrum and is able to block other viruses,” said Professor Lina.

The results of in vitro tests are very good and in humans, much is expected of this molecule, “he added. Lopinavir, a drug used against HIV, will be evaluated in combination with ritonavir.

This treatment will be experimented with or not combined with interferon beta (an immunomodulatory antiviral), to check whether this combination of molecules “helps block the inflammatory process” (respiratory problems) that appears with the coronavirus.

Finally, hydroxichloroquine, whose efficacy on Covid-19 is notably defended by Marseilles professor Raoult, was included in the trial at the request of the WHO and the State.

“We will compare these molecules to see if they are effective and well tolerated,” adds Florence Ader, emphasizing the “evolutionary” nature of Discovery. “This essay adapts to the situation. As the results progress, we will adapt. If a molecule appears ineffective, we will stop evaluating it and switch to other candidate molecules. “

Which patients will be included in the study?

This European project will include patients from Belgium, Holland, Germany, Spain and probably the United Kingdom. In France, 800 patients must participate in the clinical trial.

Patients eligible to participate in the study must be hospitalized and have breathing difficulties (pneumonia) related to the disease. “These are the patients already showing signs of seriousness who need treatment,” says Florence Ader.

And not all those who are affected by Covid-19 and who are cared for at home until recovery. Five hospitals are currently concerned: the Bichat hospital in Paris, and the Lille, Nantes, Strasbourg and Lyon teaching hospitals.

“We are following the mapping of the epidemic,” added the infectious disease specialist, adding that the hospitals included in the trial must have the human and logistical means to do so. In the hospitals concerned, patients admitted to intensive care or infectious disease departments, but also followed up in Covid-19 units, will be able to participate in the clinical trial.

When will the first treatments be evaluated?

Since March 22, the clinical trial has started in Bichat hospitals in Paris and at the CHU de Lyon. “Patients will receive treatment very quickly,” says Bruno Lina, the effectiveness of the molecules based in particular on early administration, as soon as the signs of infection appear. The trial will then be gradually extended to other hospitals.

Initial results should be known within a fortnight for the first patients included in the trial. But for them to be analyzed and enough data to demonstrate the superiority of a molecule to fight against the coronavirus, it will take more time.

“It is difficult today to say how much. We hope as soon as possible so that we can expand the use of this product. ”

Bruno LINA