INSIGHT network to study monoclonal antibodies for COVID-19 including LY-CoV555

Simon Collins, HIV i-Base

On 4 August 2020 the US NIH announced a new study of a monoclonal antibody LY-CoV555 as a treatment for COVID-19, in a study run by the INSIGHT network (responsible for the SMART and START studies).

The ACTIV-3 study will use an adaptive two-stage phase 3 design that can be adapted to test additional experimental treatments at either stage 1 or stage 2.

If a treatment appears to be safe and effective in the initial stage, the investigational therapeutic proceeds to stage 2 testing, with more participants.

LY-CoV555 was isolated from an adult who recovered from COVID-19 and was discovered by Abcellera Biologics in collaboration with NIAIDs vaccine research centre and developed by Eli Lilly.

Stage 1 will randomise approximately 300 volunteers who have been hospitalised with mild to moderate COVID-19 with fewer than 13 days of symptoms to either active treatment or placebo.  An additional 700 participants will be enrolled if the compound progresses to stage 2.Standard of care for all participants will also include remdesivir.

The use of a shared placebo group means that as new compounds are added, the chances for new participants to receive an active antibody treatment also increases.

Reference

NIH press release. NIH launches clinical trial to test antibody treatment in hospitalized COVID-19 patients. (4 August 2020).
https://www.nih.gov/news-events/news-releases/nih-launches-clinical-trial-test-antibody-treatment-hospitalized-covid-19-patients

This article was originally posted on 5 August 2020.