Monoclonal Antibody Trial Halted for Safety Concern
Brief19 has learned that the ACTIV-3 monoclonal antibody trial for the treatment of covid-19 has been paused due to a potential safety concern. An email obtained by Brief19 (below) made the announcement today.
The ACTIV-3 trial is a randomized blinded clinical trial testing the safety and effectiveness of a monoclonal antibody (Ly-CoV555) produced by the pharmaceutical giant Eli Lilly in combination with remdesivir, an anti-viral with emergency use authorization for covid-19. This trial is designed to test this combination against a combination of remdesivir and placebo alone.
No details regarding the nature of the safety concern have been obtained. However, this is the same kind of compound that President Trump received at the beginning of this month (made by Regeneron). President Trump also received remdesivir at that time.
Very few patients have received monoclonal antibodies designed to target SARS-CoV-2. Even fewer have received them in combination with remdesivir. Therefore, other than investor slide decks and press releases from the companies that make these compounds, little to nothing is known about how well they combat SARS-CoV-2 and how safe they are alone and in combination with other treatments.
This news casts doubt as to the wisdom and safety of the approach used by President Trump's medical team. Trump, who became infected with SARS-CoV-2 sometime in late September, received a combination of medications, including a cocktail of monoclonal antibody for which there is scant clinical and safety data.
Whether this current setback will turn out to be a small safety problem or a large one remains to be seen. Either way, this episode highlights the perils of proceeding with giving patients unvetted treatments on the basis of the fool-hardy premise that says, "what's the harm?"