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Discovery stops testing Remdesivir against Covid-19 for lack of evidence of its efficacy

Press release | 27 Jan 2021 - 19h11 | By INSERM PRESS OFFICE
Covid-19 | Immunology, inflammation, infectiology and microbiology | Public health

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The Discovery trial was originally launched in March 2020 by Inserm to evaluate possible treatments for COVID-19. Its European expansion (Discovery Europe) was made possible by the EU-RESPONSE[1] project funded by the European Commission (see details in the box below). On January 13th, 2021, the Discovery Europe trial Data Safety Monitoring Boards (DSMB) evaluated an interim report based on 776 patients of whom 389 received remdesivir and 387 received standard of care. The efficacy of the treatment was evaluated after 15 days and measured on the WHO-7-point ordinal scale. As a result of the evaluation, the DSMB recommended that patient recruitment be suspended.

This recommendation was based on lack of evidence of efficacy of remdesivir after 15 days and a very low probability to conclude with the inclusion of additional participants. There was also no evidence for treatment efficacy at day 29 (on the same scale or on mortality), nor in the analysis restricted to moderate-risk participants at day 15. This recommendation has been endorsed by the Discovery Europe Steering Committee.

Discovery researchers are now collecting and monitoring data on all participants enrolled in the clinical study in order to publish their detailed scientific findings in a peer reviewed scientific journal.

The Discovery Europe trial will continue in 80 centres from 14 European countries and will soon launch the clinical evaluation of a combination of two monoclonal antibodies. Beside the deployment of vaccines, it remains paramount to provide strong evidence for adding effective medicines for the treatment of patients affected by Covid-19.

 

The Discovery trial was originally launched in March 2020 by Inserm to evaluate possible treatments for Covid-19. An agreement was signed with the WHO Solidarity trial so that it became an add-on trial of Solidarity. Discovery is now part of the EU-RESPONSE project (Discovery Europe), funded through Horizon 2020, the EU’s research and innovation programme. It is a multicentre adaptative randomized platform trial for the evaluation of the clinical and virological efficacy, as well as the safety, of candidate treatment versus standard of care in hospitalized adult patients with laboratory confirmed Covid-19. The initial set of tested treatments includes lopinavir/ritonavir, lopinavir/ritonavir plus IFN-b-1a, hydroxychloroquine, and remdesivir. The primary endpoint is the clinical status at day 15, measured on the WHO 7-point ordinal scale..

In June 2020, the DSMBs of Solidarity recommended to stop the hydroxychloroquine arm for futility concern as well as both lopinavir/ritonavir containing arms for futility and safety concern. In July 2020, continuing the evaluation of remdesivir, approved for conditional marketing authorisation in the European Union, was felt important because more data were needed to fully assess its efficacy.

[1] https://cordis.europa.eu/project/id/101015736

TO CITE THIS POST :
Press release – Inserm press room Discovery stops testing Remdesivir against Covid-19 for lack of evidence of its efficacy Link : https://presse.inserm.fr/en/discovery-stops-testing-remdesivir-against-covid-19-for-lack-of-evidence-of-its-efficacy/42034/
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