The international “Discovery” study, coordinated by the French National Institute of Health and Medical Research (Institut national de la santé et de la recherche médicale – Inserm), aims to test four experimental therapies against the novel COVID-19.
FIRST OF 60 PATIENTS RECRUITED
The first of a total of 60 patients from Luxembourg foreseen to take part in the European clinical trial “Discovery” was recruited on 30 April 2020 at the Centre Hospitalier de Luxembourg (CHL). The first patient has randomly been allocated one of the planned treatments. CHL, and specifically its National Infectious Disease Department (Service National des Maladies Infectieuses – SNMI) and Intensive Care Unit, as well as the Hôpitaux Robert Schuman (HRS), together with the Luxembourg Institute of Health (LIH), had previously joined the consortium of the study upon its launch, on March 22nd.
Why is this study important?
Novel coronavirus disease (COVID-19) is an infectious disease caused by the new Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and characterised by flu-like symptoms such as cough, fever, and in more severe cases, respiratory failure. There are currently no specific treatments for COVID-19.
Aim and design of the study
A PROACTIVE INTERVENTIONAL STUDY
Discovery will assess the efficacy and safety of four experimental antiviral molecules which may be effective against COVID-19, selected according to the latest scientific evidence.
These include remdesivir, lopinavir, ritonavir, lopinavir-ritonavir associated with interferon beta and hydroxy-chloroquine, which are classified as top priority experimental treatments by the World Health Organization (WHO).
The molecules will be administered through four different treatment modalities in parallel with standard care, and will be compared to standard care alone as a reference. Namely, the modalities comprise remdesivir plus standard care; a combination of lopinavir and ritonavir plus standard care; the latter combination in the presence of interferon beta; and hydroxy-chloroquine plus standard care.
These treatment options will be randomly allocated to the study participants, although both patients and physicians will know which modality has been administered. The efficacy and safety of the drugs will be assessed 15 days following the recruitment of each participant.
Discovery aims to include a total of 3,200 patients with moderate to severe forms of the disease from various European countries.
The strength of the trial lies in its proactive and adaptive nature, which will make it possible to refine the tested therapies in real time, excluding the ones that prove to be ineffective and replacing them with new drugs being developed under ongoing research projects. This will allow the rapid identification of the most effective treatments and an ensuing fast intervention on COVID-19 patients.
The “Discovery” study is coordinated by the French National Institute of Health and Medical Research (Institut national de la santé et de la recherche médicale – Inserm. The Luxembourg participation is led by:
- Dr Thérèse Staub (CHL)
- Dr Jean Reuter (CHL)
- Dr Claude Braun (HRS)
- Dr Marc Berna (HRS)
LIH will ensure its coordination in Luxembourg, which will allow other hospitals across the country to participate. The CHL team is responsible for the recruitment of patients in the trial and cooperates closely with the Clinical and Epidemiological Investigation Centre (CIEC) of the LIH Department of Population Health. The launch of the study was facilitated by the rapid mobilisation of the Ministry of Health and of the National Research Ethics Committee (CNER), which ensured the implementation of the necessary authorisation and protocol revision procedures.
“We are delighted to have so promptly begun the enrolment operations, just a few weeks after the official launch of the trial”, states Dr Staub, Head of the SNMI and Principal Investigator of the study. “The aim of the project is to provide concrete treatment solutions to a growing number of patients in critical state as quickly as possible. Tight collaboration with the competent national authorities and LIH has been decisive in ensuring the swift roll-out of the study, therefore marking the start of our contribution to the containment of the ongoing pandemic in Luxembourg and abroad”, she adds.
“We are proud to have put our expertise in clinical trial set-up at the service of the Luxembourgish community by contributing to the timely implementation of this prestigious international study”, concludes Prof Laetitia Huiart, Director of the LIH Department of Population Health and affiliated professor at the Faculty of Science, Technology and Medicine of the University of Luxembourg.
The study will also complement the data that will be generated under Solidarity, an upcoming international clinical trial under the auspices of the World Health Organization.
Discovery, coordinated by Inserm, is a European trial financially supported by the EU projects COMBACTE, PREPARE and RECOVER.
Research Luxembourg is a joint initiative of the main players in Luxembourg public research Luxembourg Institute of Health (LIH); Luxembourg Institute of Socio-Economic Research (LISER); Luxembourg Institute of Science and Technology (LIST); Laboratoire National de santé (LNS); University of Luxembourg; Fonds National de la Recherche (FNR), supported by the Ministry of Higher Education and Research. The main aim of the initiative is to promote scientific cooperation in Luxembourg and to communicate the activities of the sector as a whole.