Authors: Kate Lovesey, Future Science Group
A preliminary analysis published in The New England Journal of Medicine, using data collected from the Adaptive COVID-19 Treatment Trial (ACTT), has demonstrated that remdesivir improves time to recovery, supporting proposals that it should be the standard treatment for hospitalized adults with COVID-19.
On 21 Feb 2020, the randomized, double-blind, controlled ACTT, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), enrolled 1063 participants, from 10 countries over 58 days, who tested positive for COVID-19 with lower respiratory tract involvement.
The participants all received a local standard care and were either injected intravenously with a 10-day course of the antiviral remdesivir (developed by Gilead Sciences, CA, USA) or a placebo. The ACTT defined recovery as a participant being discharged from the hospital or being medically stable enough to be discharged from the hospital.
The results demonstrated that patients receiving remdesivir had a significantly shorter time to recovery. The 538 participants who were injected with remdesivir had a median time to recovery of 11 days, compared with the 521 participants receiving the placebo, who had a median time to recovery of 15 days.
Researchers observed a mortality rate of 7.1% at 14 days for participants injected intravenously with antiviral remdesivir, compared with a mortality rate of 11.9% at 14 days for participants receiving the placebo. However, while this suggests a survival benefit, these results were not statistically significant.
Antiviral remdesivir was found to be the most effective for hospitalized participants with severe SARS-CoV-2 infections, requiring supplemental oxygen therapy, whereas other participant subgroups were less conclusive.
Also, the clinical status of the study arms on day 15 demonstrated that the likelihood of improvement in the ordinal scale was higher in the remdesivir arm compared with the placebo arm.
Overall, the results support antiviral remdesivir as the standard treatment for hospitalized participants with severe SARS-CoV-2 infections who require supplemental oxygen therapy. However, the authors note that there is still a need to evaluate the effectiveness of antivirals with other therapeutic agents, in order to improve the clinical outcomes of COVID-19 patients.
On 8 May 2020, the NIAID began a second clinical trial termed ACTT 2 to determine the effectiveness of remdesivir in combination with baricitinib, an anti-inflammatory drug, compared with remdesivir alone for treating COVID-19 patients.
Sources: Beigel JH, Tomashek KM, Dodd LE et al., Remdesivir for the Treatment of Covid-19 — Preliminary Report. N. Engl. J. Med. 1-12, (2020). doi: 10.1056/NEJMoa2007764; www.nejm.org/doi/10.1056/NEJMoa2007764