Since the appearance of COVID-19, the international community has mobilized to find treatments for this viral infection. Remdesivir has received worldwide attention as a potentially effective treatment for the severe form of the infection and has been used increasingly to treat patients in hospital. As the High Authority for Health reminds us, this antiviral from the Gilead laboratory was the first to obtain, on July 3, 2020, a conditional marketing authorization for the treatment of patients with pneumonia associated with COVID-19 and receiving a oxygen therapy. The laboratory had even submitted a file for reimbursement.
But as more clinical studies were carried out, one of which was published in the journal The Lancet, their results suggested “a moderate or weak efficacy of remdesivir on clinical improvement. of hospitalized patients for the management of COVID-19 and “an absence of efficacy of remdesivir on mortality. ” affirms on this subject the French Society of Pharmacology and Therapeutics. Proof that this craze has died down, Inserm announced on January 27 that it is stopping testing remdesivir against Covid-19, for lack of evidence of its effectiveness, as part of its Discovery trial launched in March to assess thes possible treatments for Covid-19.
Discovery trial: the molecules tested disappoint
At the start of the pandemic, Inserm set up Discovery, a European clinical trial aimed at evaluating the effectiveness of four antiviral treatments repositioned in the indication of Covid-19 requiring hospitalization: remdesivir, hydroxychloroquine, lopinavir and interferon beta-1a. Its objective is to evaluate five different treatment strategies for SARS-CoV-2, a control group (with routine care) and four experimental treatment groups. At the same time, the World Health Organization (WHO) set up a large consortium of clinical trials called “Solidarity”, the objective of which was also to test the effectiveness of these four treatments.
“Launched in March under the aegis of the global Solidarity clinical trial, Discovery is a clinical trial of efficacy and safety. This is the only large-scale European trial involving on Covid-19 treatments », Explains Inserm on this subject. One of the four treatment groups was to receive the combination remdesivir + standard care for hospitalized patients for severe Covid-19. Last December, the organization was already making it known that none of these treatments “has any effect on clinical improvement of patients, does not significantly reduce overall mortality, the risk of having recourse to mechanical ventilation or the length of hospitalization. ”
Lack of proof of efficacy after 15 days of treatment
But the decision had been made to continue patient inclusions of the “remdesivir” group because the continued evaluation of this drug was deemed important to have more data “in order to fully assess its effectiveness. When announcing the end of the tests on remdesivir, Inserm specifies what motivated its decision. Its experts say that on January 13, the trial’s Data and Safety Oversight Boards (DSMBs) assessed data from an interim report based on 776 patients: 389 had received remdesivir and 387 standard care. The effectiveness of the treatment was evaluated after 15 days and measured on the WHO reference scale.
It was following this assessment that the DSMB recommended suspending patient recruitment. “This recommendation was based on the lack of evidence for the effectiveness of remdesivir after 15 days and on a very low probability of concluding with the inclusion of additional participants. There was also no proof of the efficacy of the treatment on day 29, nor from the results of an analysis limited to participants at moderate risk on day 15. ”, underlines Inserm. Discovery researchers will nevertheless consolidate the data on all the participants included in the clinical study, to publish their detailed results in a scientific journal.
In addition, the Discovery trial benefited from a European expansion and it is in this context that it will continue in 80 centers in 14 European countries, in order to evaluate a combination of two monoclonal antibodies targeted on SARS CoV2. Because in addition to the deployment of vaccines, “it remains essential to find new drugs and provide solid evidence of their effectiveness on patients affected by Covid-19”, concludes Inserm. This decision regarding remdesivir is added to WHO mixed conclusions and several French health agencies in particular the High Authority of Health and the High Council of Public Health, due to uncertainties about its efficacy and tolerance.
To find out more about the coronavirus, the editorial staff invites you to discover its more complete and regularly updated articles:
- an article on Covid-19 disease and the evolution of the epidemic
- an article on the different screening tests
- an article on vaccines under development.