COVERAGE, an innovative clinical trial for early treatment of Covid-19
Launched on the 15th April by the University of Bordeaux and Bordeaux University Hospital, this trial will compare four different treatments in patients over the age of 65 and who, from the onset of the disease, are treated at home. It benefits from the support of the University’s Covid-19 coordination unit.
An outpatient trial at home to avoid hospitalization
Although clinical trials generally take place in hospitals, COVERAGE is different in that it will be conducted directly at patients’ homes. Mobile teams, consisting of a physician and a nurse, will make home visits to include those patients who have tested positive for Covid-19 and to administer one of the trial treatments.
The target patients for this trial in the Bordeaux metropolitan area are men and women over the age of 65, a population that is particularly concerned by Covid-19 infections and that faces a high risk of disease aggravation. By treating them in their homes, they can receive ongoing follow-up by telephone or digital devices and thus have the advantage of treatment and strict monitoring without the upheaval of hospitalization.
The trial will also provide an opportunity to analyze the optimal conditions for coming out of lockdown for this population of over 65, providing possible ways forward for local and national authorities.
A large-scale trial comparing 4 types of treatment
Four types of treatments will be administered to four different groups of patients, including hydroxychloroquine. All in all, more than 1,000 patients should be followed, receiving precise follow-up throughout the treatment in order to track the development of the disease. Healthcare professionals in the community will be closely involved in the process and represent a key link in the effective implementation of the trial.
The COVERAGE trial will be carried out with local Covid-19 outpatient response platforms operating in the Gironde area: the “15” emergency hotline, Covid-19 diagnosis units, hospital emergency rooms, the VILLEHOP and Ange Gardien (RAFAEL Covid) platforms, mobile care home support teams and the ‘SOS Médecins’ house call service. It will also collaborate with local GPs in their surgeries, health centers and COVID consultation units.
The national authorities have shown an interest in the trial and asked Bordeaux University Hospital and University to consider extending it to other major cities and university hospitals in France. Requests for funding have been filed with the Ministry for Solidarity and Health and also with the European Commission.
Bordeaux University Hospital and the University of Bordeaux are the sponsors of the COVERAGE trial. The principal investigator is Professor Denis Malvy, a specialist in infectious diseases and head of the Tropical and Travel Diseases Unit at Bordeaux University Hospital and a researcher in the IDLIC “Infectious Diseases in Lower-Income Countries” team headed by Dr Xavier Anglaret at the Bordeaux Population Health Research Centre (BPH - INSERM and the University of Bordeaux). The EUCLID/F-CRIN Platform (European Clinical Trials Platform & Development) at the Bordeaux Clinical Investigation Center is also involved in the project.
The trial is supported by Bordeaux University Hospital, in liaison with the University’s General Medicine Department, INSERM, the University of Bordeaux and the National College of General Practice Teaching. The trial received the go-ahead from the French National Agency for Medicines and Health Products Safety (ANSM) on the 10th April 2020 and a positive opinion from the Ethics Committee (Comité de Protection des Personnes).
In partnership with the City of Bordeaux and Bordeaux Metropolitan Authority
The City of Bordeaux and Bordeaux Metropolitan Authority are partnering the trial and have provided considerable logistical support to start recruitments in record time for such a trial. For example, the Albert Thomas Gymnasium near Chaban-Delmas Stadium has been placed at the disposal of Bordeaux University Hospital for the trial kick-off as a facility for equipment storage and putting together the sampling kits that will be used in patients’ homes. The telephone follow-up and data analysis unit is also located on the site. As this trial monitors patients in their own homes, no patients infected by Covid-19 will come to the site and the only people present there will be the hospital and university staff, along with the interns and students who have volunteered.
A large number of other partners from the private-sector have provided logistical support and equipment to facilitate a quick launch of this clinical trial and its successful kick-off owes much to their generosity: Palau automobile dealership, SIPA automobile dealership, EDENAUTO automobile dealership, Europrisme, SoLocal, Bureau Vallée, Auchan, Arcade, SAS Objectif Sécurité, GMF insurance, EDF, Château d'Eau, EDF Ingenium, EDF CNPE BLAYAIS, IKEA, Leroy Merlin, Les P’tits plats d’Audrey restaurant, and Laurent Lajugie.