COVID-19: neutralizing Ab treatment shows promise for mild-moderate disease

  • Chen P & al.
  • N Engl J Med
  • 28 Oct 2020

  • curated by Liz Scherer
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • A neutralizing antibody (Ab) shows promise against mild to moderate COVID-19 in a phase 2 trial.
  • An interim analysis suggests that a single, intravenous (IV) infusion of the neutralizing Ab LY-CoV555 2800 mg (but not 700 or 7000 mg) accelerates decreased viral load at day 11, reduces hospitalization, and lowers symptom burden.

Why this matters

  • Ongoing data collection will yield further information about LY-CoV555 IV efficacy for emergency, outpatient treatment of mild-moderate COVID-19.

Key results

  • 452 patients (309 LY-CoV555, 143 placebo).
  • Day 11, observed mean decline in log viral load from baseline: 
    • 2800 mg: −0.53 (P=.02, lower viral load factor=3.4).
    • 700 mg: −0.20 (P=.38).
    • 7000 mg: 0.09 (P=.70).
  • Symptom score days 2-6 from baseline were slightly lower with LY-CoV555 vs placebo. 
  • Day 29 hospitalizations, pooled: 1.6% with LY-CoV555 vs 6.3% with placebo. 
  • Serious adverse events (AEs): 0.0% with LY-CoV555 vs 0.7% placebo.
  • AEs: 22.3% with LY-CoV555 vs 24.5% placebo.

Study design

  • Interim, phase 2 analysis from ongoing, randomized, double-blind, placebo-controlled, single-dose trial evaluating LY-CoV555 safety, efficacy in outpatients with mild to moderate COVID-19.
  • Funding: Eli Lilly.

Limitations

  • Interim analysis; more data are needed.
  • Inability to assess lower respiratory tract secretions.