The Phase 3 NIH study assessed the efficacy and safety of a single dose of immune modulators including intravenous abatacept (Orencia) 10 mg/kg compared with placebo and standard of care (SOC).

The investigators found that although abatacept did not result in significant improvement, there was a trend toward improved time to recovery as determined by the day of discharge, which was the primary endpoint of the study.

With regard to secondary endpoints, the biologic decreased risk of death and improved clinical status at 28 days after the initiation of therapy. Specifically, the risk of death was 11% in those receiving abatacept plus SOC vs. 15% in those receiving placebo plus SOC. Furthermore, those patients who received abatacept were 34.2% more likely to experience clinical improvement. Relative improvement in mortality was comparable in both moderately and severely ill COVID arms. Importantly, no new safety concerns were found.

Discussion questions: Would you consider adding abatacept or other immune modulators? If to speed recovery or decrease risk of death in moderate to severe COVID? Please explain. What are the perceived benefits and drawbacks? How would you monitor clinical outcomes?