Remdesivir Shortened COVID-19 Time to Recovery
A new article published in the New England Journal of Medicine reported on the NIAID sponsored clinical study, which tested remdesivir on COVID-19 disease patients in a hospital setting.
The data and safety monitoring board for the phase 3 Clinical Trial NCT04280705, recommended early unblinding of the results on the basis of findings from an analysis that showed a shortened time to recovery in the remdesivir group.
This preliminary result is from the 1,059 patients with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days, as compared with 15 days, in those who received a placebo.
Enrollment for this U.S. NIH sponsored study began on February 21, 2020, and ended on April 19, 2020.
There were 60 trial sites and 13 subsites in the United States (45 sites), Denmark (8), the United Kingdom (5), Greece (4), Germany (3), Korea (2), Mexico (2), Spain (2), Japan (1), and Singapore (1).
This is important news since several therapeutic agents are currently being evaluated for the treatment of Covid-19, but none have yet been shown to be efficacious.
Remdesivir (GS-5734), an inhibitor of the viral RNA-dependent, RNA polymerase with inhibitory activity against SARS-CoV and the Middle East respiratory syndrome (MERS-CoV), was identified early in 2020 as a promising therapeutic candidate for Covid-19 disease because of its ability to inhibit SARS-CoV-2 coronavirus in vitro.
In addition, in nonhuman primate studies, remdesivir initiated 12 hours after inoculation with MERS-CoV, reduced lung virus levels, and lung damage.
These researchers said ‘the benefit was most apparent in patients with a baseline ordinal score of 5 (requiring oxygen), a finding most likely due to the larger sample size in this category.
Furthermore, an ‘additional analyses of outcomes such as the time to a one- or two-point improvement on the ordinal scale score will be conducted after the full cohort has completed 28 days of follow-up and may provide additional insight into the treatment of this critical subgroup.’
‘Our findings highlight the need to identify Covid-19 cases and start antiviral treatment before the pulmonary disease progresses to require mechanical ventilation,’ concluded this NEJM article.
In the USA, the Food and Drug Administration has made remdesivir available under an Emergency Use Authorization for the treatment of adults and children with severe Covid-19 disease.
This phase 3 trial (NCT04280705) was sponsored and primarily funded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD. No conflicts of interest were disclosed.
Precision Vaccinations publishes COVID-19 disease therapeutic development news.