Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial

SPS commentary:

The proportion of patients with COVID-19–related hospitalisations or ED visits was 5.8% (9 events) for placebo and 0.9% (1 event) for combination treatment.  No other clinical outcomes were reported.  Authors state that further ongoing clinical trials will focus on assessing the clinical benefit of antispike neutralizing antibodies in patients with COVID-19 as a primary end point.

A related editorial highlights that these results are in contrast to reports which found 2800 mg dose of bamlanivimab monotherapy, compared with placebo, achieved statistical significance for the primary outcome of the mean change in viral load from baseline at day 11.  It states that this difference in outcomes has arisen, because in the earlier publication, follow-up for the placebo group was incomplete at the time of the database lock. In the final analysis reported here the longer follow-up for the placebo group, which is now complete, resulted in changes in the primary outcome among that group. The comparison of the monotherapy groups against the final results for the placebo group led to changes in the effect sizes, and the loss of previously reported statistical significance in the group that received 2800 mg of bamlanivimab.  The editorial discusses the difficulty in reviewing interim study results, which would generally be avoided, but that these are extraordinary times.

It concludes that clinicians face an ever-changing treatment narrative and must make decisions based on the best information available. While the world waits for widespread administration of effective vaccines and additional data on treatments, local efforts should work to improve testing access and turnaround time and reduce logistical barriers to ensure that monoclonal therapies can be provided to patients who are most likely to benefit.