NIH’s new trial, New Remdesivir and Baricitinib Results, and Vaccine Testing in Older Adults

Over the past weeks there have been several exciting updates in COVID-19 clinical trials. The first are some results released from the ACTT-2 trial, which is evaluating combined Remdesivir with Barcitinib (a JAK inhibitor). This trial, in collaboration with Eli Lily, reported beneficial outcomes of the combined therapy in reducing COVID-19mortality by 35% (by Day 29, p=0.04) , reducing average time to recovery from 8 to 7 days, and  improving overall clinical outcomes (defined as time to discharge, p=0.04). Given positive results of combined therapy in the ACTT-2 trial, there is hope on the horizon for ACTT-3 trial, a combined therapy trial of interon-beta and Remdesivir. Also on the Remdesivir front, the final report from the ACTT-1 trial testing a regimen of only Remdesivir was recently published in the New England Journal of Medicine (Beigel JH, et al. 2020). This study confirmed similar findings from the initial preliminary report that was published (Beigel JH, et al. 2020).

The second exciting update is the announcement of a new NIH trial to study hyperimmune intravenous immunoglobulin (hIVIG) that contains convalescent antibodies from COVID-19 donor’s plasma. This therapy will be combined with Remdesivir and compared to a control regimen of Remdesivir alone. It will be interesting to compare the efficacy of this therapy to convalescent plasma given the current controversy about COVID-19 treatment with convalescent plasma. The study is aiming to provide hIVIG to patients at the earliest time point of symptom onset. It will be interesting to see if the trial results demonstrate  that preemptive antibody therapy before severe symptom onset may reduce disease progression. 

Last but certainly not least, the Moderna mRNA vaccine trial published their results demonstrating efficacy of the vaccine in older adults (Anderson EJ, et al. 2020). It will be crucial to continue to monitor and test the vaccines in populations such as older adults, pregnant women, children, and recovered COVID-19 patients. As vaccine trials are completed, it will be important to continue to monitor both safety and long term efficacy.