The “Discovery” clinical trial for the treatment of COVID-19 began on Sunday, March 22, 2020 in Lyon

On The March 30, 2020

“Discovery”, a real-time, adaptive clinical trial, will test four different treatments against Covid-19 and will enroll 800 patients in France.

The protocol for the “Discovery” clinical trial, coordinated by the Inserm, was implemented in record time by clinicians and researchers from the REACTing (REsearch and ACtion targeting emerging infectious diseases) consortium led by the World Health Organization (WHO).

On Sunday, March 22, 2020, the first patients were enrolled in the clinical trial, which is being conducted at the Hôpital Bichat in Paris in Professor Yazdan Yazdanpanah’s department (APHP), and at the Croix-Rousse Hospital in Lyon in Professor Florence Ader and Professor Bruno Lina’s departments (Hospices Civils de Lyon - HCL, Centre International de Recherche en Infectiologie - CIRI), which are both members of the Ecofect LabEx.The trial plans to enroll 800 patients in France, and a total of 3,200 patients across Europe, with trial sites in Belgium, Holland, Germany, Spain and England.

The clinical trial will test four different and complementary treatments, some of which are a single molecule, and others a combination of molecules:
  • Remdesivir: an antiviral treatment originally developed for the Ebola virus, but which is effective against a wider range of viruses. In vitro data have shown that remdesivir can prevent the replication of coronaviruses, including Covid-19.
  • Lopinavir + ritonavir: this is a combination of two molecules used against HIV. The in vitro data are promising and a first clinical trial has been carried out in China. The “Discovery” trial will provide further testing of this combination, since the Chinese clinical trial included too few patients, some of whom were included in the later stages of the disease, and it was too late for the antiviral to be effective.
  • Lopinavir + ritonavir + interferon-ß: this combination should enable us to treat both phases of the disease: a) the viral replicative phase, during which antivirals such as lopinavir and ritonavir may have an effect, and b) the immunopathological phase with an inflammatory syndrome, during which clinicians hope that interferon-ß may be able to act by inhibiting the inflammatory process.
  • Hydroxychloroquine: this is used to treat malaria. It is also used as an anti-inflammatory and immunomodulator to treat certain chronic diseases such as rheumatoid arthritis and lupus. The WHO and the French government requested that hydroxychloroquine be included in the “Discovery” trial to determine its potential effectiveness against Covid-19.

Find out more about Chloroquine, Hydroxychloroquine and the clinical trials

Patient eligibility criteria

This protocol was established to include patients from infectious disease and intensive care units. Patients from Covid-19 units which have been set up within units at the HCL hospitals that do not usually treat patients with infectious diseases may also be enrolled. Patients will be enrolled in the trial in the early stages of the disease so that the antiviral treatments will be more effective.

Patients participating in the trials are required to meet two criteria:

  • have a respiratory infection and/or require oxygen support;
  • be admitted to hospital (excludes outpatients)

Clinical trial details

Five French hospitals are currently participating in the trial (Paris, Lyon, Lille, Nantes and Strasbourg) and patients are being enrolled gradually since the beginning of the trial. The number of patients will be progressively increased in France, then in Europe, when patients from trial sites in other countries are enrolled in “Discovery”.

The first efficacy and safety evaluations will be assessed on treatment day 15 for each patient, so there needs to be a sufficient number of patients in the first wave to produce the first results.

“Discovery” is a clinical trial conducted in real-time, as it is designed to include patients affected by the epidemic, and is adaptive as the trial may be amended at any time depending on the effectiveness of the four treatments being tested, in order to enroll more patients for one of the more effective treatments if another treatment proves ineffective.

You can find out more by watching the press conference given by Professor Florence Ader (HCL, CIRI, Université Claude Bernard Lyon 1) and Professor Bruno Lina (HCL, CIRI, Université Claude Bernard Lyon 1, Ecofect LabEx) below.