In the midst of the global Coronavirus pandemic, a European clinical trial to evaluate four experimental treatments began on March 22, 2020.
This clinical trial entitled “Discovery” is being coordinated by French National Institute of Health and Medical Research (“Inserm”) as part of the Reacting consortium. The data from this trial will be included in another international clinical trial that will soon begin under the authority of the World Health Organization (WHO), called “Solidarity”.
The French part of this European trial will be directed in Lyon, by Florence Ader, an infectious disease specialist at the International Center for Research in Infectious Disease.
In France, at least 800 French patients suffering from severe forms of COVID-19 will be enrolled. Five French hospitals are taking part in this trial: Paris, Lille, Nantes, Strasbourg and Lyon. More hospitals will be included depending on the epidemiological situation, with a priority given to the hardest-hit hospitals. The clinical trial aims to recruit 3,200 European patients from Belgium, Germany, Luxembourg, the Netherlands, Spain, and the United Kingdom.
The purpose is to assess the efficacy and safety of four experimental therapeutic protocols, which, in light of the latest scientific information, especially from China, might be effective against COVID. The World Health Organization (WHO) gave these drugs a priority status as experimental treatments to be examined and used in clinical trials.
Allocation of patients to the various treatment modalities will be randomized, i.e. by random draw, but patients and physicians will know which treatment is used (this is called an open trial).
Fifteen days after each patient begins treatment, the efficacy and safety will be evaluated.
Florence Ader explains that this is an “adaptive” trial, where changes can be made in real time. Thus, ineffective treatments can be dropped and replaced by others, which appear promising according to emerging scientific data.
The four initial treatments to be tested are:
- lopinavir combined with ritonavir,
- the latter, administered with or without, interferon beta,
- and hydroxychloroquine.