Lyon (AFP)
Staying away from the controversies aroused by Professor Raoult, Professor Florence Ader explains to AFP how the lessons of Ebola were learned. She is piloting a clinical trial in Lyon aimed at finding a treatment against the coronavirus.
Blue eyes behind round glasses, Professor Florence Ader answers questions from AFP from the Croix-Rousse Hospital of the Hospices Civils de Lyon (HCL), "her element". She has been at the heart of a "crazy project" for a month, far from her usual daily life as a pulmonary infectious disease specialist.
From the outset, it sweeps the controversial questions around the supposed effectiveness of the chloroquine touted by Professor Didier Raoult. "We have to get out of the buzz and give priority to medical research," she said. Professor Ader is one of the rare women present in the current medical debate and chooses discretion in front of some of her thunderous colleagues.
She therefore prefers to speak of the "feat" that the French public service has, according to her, managed to set up with Discovery, a clinical trial coordinated by Inserm which is to test four treatments, including hydroxychloroquine, on 3,200 patients. Europe, including at least 800 in France. Only hospitalized and severely ill patients.
"This is one of the big lessons from the 2014 Ebola crisis. The one and only randomized trial had been started too late, with only 72 patients."
Today, "being able to set up a clinical trial of this type in real time is very hopeful". France is capable at the same time of "deploying a medical network on the territory to treat patients and of coordinating a national research organization to provide the fastest possible response".
Hexagon is also the first European country to have set up and launched such a trial, she insists. Its budget: a few million euros, funded by the General Directorate of Care Offerings of the Ministry of Health. The World Health Organization (WHO) is also to launch its major trial, "Solidarity", but it is still in the preparatory phase.
- "No concessions" -
Discovery started a week ago. To date, it has included 123 patients in seven hospitals. Some doctors have reported to the press in recent days, problems convincing Covid-19 patients, who wanted Plaquenil (derived from chloroquine) and nothing else. But no, she says, there is "no difficulty" in finding volunteers.
Each participant is allocated one of the four treatments tested or standard care, at random, after a digital randomization.
Are tested: remdesivir (antiviral initially designed for Ebola), lopinavir in combination with ritonavir (anti-HIV), the same combination but associated with interferon beta to try to lower the inflammatory process and hydroxychloroquine (cousin chloroquine, but with less risk of toxicity, this anti-malarial has the advantage of being known and inexpensive).
And she insists: "For the moment we have no confirmation of the reality of the effectiveness of these treatments. We only have disparate data on these molecules. We have in vitro data for some, not for d 'others; data on animal models for some, but not all, other data on small series of patients, not for others ".
Hence for her the importance of making "no concessions" and ensuring the same level of requirement despite the urgency of a pandemic which has already killed some 30,000 people in the world, according to an assessment established by AFP .
"The more significant and methodologically robust the results, the higher the level of evidence and the more we will be of service to people," assumes Florence Ader.
- No specific deadline -
Even if it is heavy, it ensures that this test is carried out with all the speed and adaptability necessary to the context.
Pr Ader is surrounded by around twenty people who work hard. First a project manager who manages the very heavy logistics from a center in the south: what treatment? Sent to which patient? In what city ? And when ?
In the field, hundreds of technicians, researchers, clinical trial doctors collect the data. And instructs the Inserm methodology team to use them.
The first patient assessments will begin after 15 days of treatment, in about a week. One will be able to estimate in particular if their clinical state improved, if they tolerated the treatment.
After analyzing these initial data, it is possible that the trial may abandon the tests of one or more of the four visibly ineffective treatments in order to test new ones. But "there is not yet a precise deadline, interim analyzes will be regularly carried out", concludes Professor Ader, keeping the pressure at a good distance.
© 2020 AFP