Launch of a European clinical trial against COVID-19
See here an analysis of the similar UK protocol: https://covexit.com/oxford-recovery-evaluation-of-covid-19-therapy-flawed-against-hydroxychloroquine-and-dangerous-to-patients/
See Media Release:
A European clinical trial to evaluate four experimental treatments for COVID-19 starts today. Coordinated by Inserm as part of the Reacting consortium, this trial will include at least 800 French patients with severe forms of COVID-19.
A clinical trial, called Discovery and coordinated by Inserm as part of the Reacting consortium, starts today in France to test four experimental treatments against COVID-19. This is a European project, the French part of which is financed by the Ministries of Higher Education, Research and Innovation (MESRI) and Health and Solidarity (MSS). The European part is supported at least by COMBACTE, PREPARE and RECOVER. It is led by Florence Ader, infectiologist in the Infectious and Tropical Diseases Department of the Croix-Rousse Hospital of Lyon University Hospital and researcher at the CIRI International Research Centre in Infectiology (Inserm/CNRS / Claude Bernard University Lyon 1).
The objective is to evaluate the efficacy and safety of four experimental therapeutic strategies which, in light of latest scientific information, might be effective against COVID-19.
“We analysed data from the scientific literature on SARS and MERS coronaviruses and the first publications on SARS-COV2 from China in order to come up with a list of antiviral molecules to be tested: remdesivir, lopinavir and ritonavir in combination, the latter being administered with or without interferon beta and hydroxychloroquine. The list of these potential drugs is also based on the subset of experimental treatments classified as top priorities by the World Health Organization (WHO).
The great strength of this trial is its “adaptive” nature. This means that ineffective experimental treatments can very quickly be dropped and replaced by other molecules that emerge from research efforts. We will therefore be able to make changes in real time, in line with the most recent scientific data, in order to find the best treatment for our patients,” explains Florence Ader.
It is planned to include 3200 European patients from Belgium, France, Germany Luxembourg, the Netherlands, Spain, Sweden, and the United Kingdom. In France, at least 800 hospitalized COVID-19 patients will be recruited in conventional medicine departments or in intensive care. “Five French hospitals will initially participate (Paris – Hôpital Bichat-AP-HP, Lille, Nantes, Strasbourg, Lyon) and then we will open other centres to reach at least 20 participating establishments. Our strategy of opening centres will follow the epidemiological situation of the epidemic with a priority for opening new sites in hospitals under high pressure”. Recruitment starts today.
“This trial is designed to be pragmatic and adaptive. Its aim is to analyze the efficacy and safety of treatment options for patients within a limited time frame. It is a resolutely proactive approach to develop tools against the disease,” she concludes.
This trial will also complement the data that will be collected as part of another international clinical trial that will soon begin under the auspices of the World Health Organization, called Solidarity.
For more information:
The DISCOVERY trial includes five treatment modalities:
- standard of care
- standard of care plus remdesivir
- standard of care plus lopinavir and ritonavir,
- standard of care plus lopinavir, ritonavir and interferon beta
- standard of care plus hydroxy-chloroquine.
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). The analysis of treatment efficacy and safety will be evaluated 15 days after inclusion of each patient.