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COVID-19 Management

Neutralizing Antibody Medication for Outpatient COVID-19: Interim Results from the BLAZE-1 RCT

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BACKGROUND AND PURPOSE:

  • Neutralizing monoclonal antibodies may reduce viral load, lessens symptoms of COVID-19, and reduce hospitalizations
  • LY-CoV555 antibody binds with high affinity to the receptor-binding domain of SARS-CoV-2
  • Chen et al. (NEJM, 2020) report early results on the efficacy and safety of LY-CoV555, a monoclonal antibody treatment for COVID-19

METHODS:

  • Randomized, double-blind, placebo-controlled, single-dose trial
    • 41 centers in the US
    • Interim analysis of ongoing phase 2 trial
  • Data source
    • Blocking Viral Attachment and Cell Entry with SARS-CoV-2 Neutralizing Antibodies (BLAZE-1) trial
  • Participants
    • Mild or moderate COVID-19
    • Managed as outpatients
  • Intervention
    • Antibody LY-CoV555: Single IV infusion in either a 700 mg, 2800 mg, or 7000 mg dose
    • Placebo
  • Primary outcome
    • Change from baseline in viral load at day 11

RESULTS:

  • 452 patients included in primary analysis
    • Antibody group: 309 patients
    • Placebo: 143 patients
  • By day 11, most patients had progressed towards viral clearance, even those in the placebo group
  • Among the intervention groups, patients who received the 2800-mg dose of LY-CoV555 had the greatest decrease in viral load compared to placebo
    • Mean decrease from baseline: −0.53 (95% CI, −0.98 to −0.08; P=0.02)
    • Viral load was lower by a factor of 3.4
  • On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo
  • Percentage of patients who had a Covid-19–related hospitalization or visit to an emergency department
    • Antibody group: 1.6%
    • Placebo group: 6.3%
  • Safety profiles were similar between groups

CONCLUSION:

  • A 2800-mg dose of neutralizing antibody LY-CoV555 in patients with mild to moderate COVID-19 seems to accelerate a reduction in viral load by day 11, compared to placebo
    • 11 days was not a meaningful endpoint as most patients in the placebo group also cleared the virus by day 11
  • However, these results do indicate fewer hospitalizations and a lower symptom burden vs placebo
  • The authors conclude that

If these results are confirmed in additional analyses in this trial, LY-CoV555 could become a useful treatment for emergency use in patients with recently diagnosed Covid-19

Learn More – Primary Sources:

SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19

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