Coronavirus clinical trials: Europe is getting started, what can we expect?

Four experimental treatments against Covid-19 are being tested in Belgium, the Netherlands, Luxembourg, the United Kingdom, Germany, Spain and France from Sunday March 22, 2020. In France, nearly 800 people hospitalized have been included.

Remdesivir, lopinavir, ritonavir, hyroxychloroquine … these drug names were not combined to give you a headache, but to try to find an effective treatment to treat severe forms of Covid-19.

Indeed, a clinical trial which answers to the name of Discovery was launched in Europe on Sunday March 22, 2020. Coordinated by the National Institute of Health and Medical Research (Inserm) in its French section, it is piloted by the infectiologist Florence Ader, from the Croix-Rousse hospital at the CHU de Lyon, and also a researcher at the International Center for Research in Infectious Disease CIRI.

Which countries are affected?

The trial will take place with 3,200 patients selected in Belgium, the Netherlands, Luxembourg, the United Kingdom, Germany, Spain and France.

Other countries may be added to it. The five French establishments participating in the project are those of Paris (Bichart-AP-HP hospital), Lille, Nantes, Strasbourg and Lyon. In total, around twenty French centers will gradually be added to this study.

“”Our strategy for opening a center will follow the epidemiological reality of the epidemic, with priority given to the opening of the trial in hospitals under high pressure””

INSERM

How many people participate in this test?

It is expected that at least 800 people hospitalized in France for a Covid-19 infection in a medical department, or directly in intensive care, will be included in the study. “Patients eligible to enter the trial are hospitalized patients, with a number of predetermined criteria and marked out in the protocol.

These include the presence of virus-linked pneumonia, and / or having need oxygen support. These are the patients who need treatment. Patients who stay at home on an outpatient basis are not eligible for this protocol, as it takes place exclusively in the hospital, “says Florence Ader. .

What treatments are tested?

The objective of this research is to assess the efficacy and safety of four experimental treatments: remdesivir, lopinavir in combination with ritonavir, the latter treatment being associated or not with interferon beta, and hydroxychloroquine.

“We analyzed the data from the scientific literature concerning the SARS and MERS coronaviruses as well as the first publications on SARS-COV2 from China to arrive at a list of antiviral molecules to be tested,”

Explains the researcher.

This list of drugs is also consistent with that established by the World Health Organization.

Patients will receive, either randomly but transparently, either standard care, or standard care and remdesivir, or standard care as well as lopinavir and and ritonavir, or standard care, lopinavir, ritonavir, and beta interferon, standard care and hydroxychloroquine.

After two weeks of treatment, the researchers will analyze the efficacy and safety of the treatment for each patient. The adaptive peculiarity of this trial makes it possible to easily abandon and replace any ineffective treatment.

When will we get results?

Health Minister Olivier Véran said on LCI that the first available data should be released within 15 days. At the same time, he called for caution, as experimental treatments can sometimes have disappointing results.