COVID 19 CME Course Update: Regeneron – Monoclonal Antibodies April 2021

Regen COV SQ in prevention symptomatic infection in high risk patients April 2021

NIH/NIAID Phase 3 Double Blind Clinical Trial Data

  • 1500 patients – 750 treatment with RegenCOV 1200mg SQ /750 placebo
  • Demographics
    • 41% Hispanic
    • 9% African American
    • 31% at least one high risk health factor
  • Household contacts – living with COVID 19 positive taking appropriate precautions (Historically 10% symptomatic transmission rate)
  • Treatment – RegenCOV 1,220mg in 4 separate SQ shots within 4 days of household contact positive COVID test
  •  Results at 29 days
    • Symptomatic Infections 
      • Placebo – 59  
      • Treatment – 11 
    • Adverse Events – ER visit or Hospitalization
      • Placebo – 27
      • Treatment – 2
  • What is New?
    • SQ instead of IV administration – much less of a barrier to treatment.
    • Rapid onset of action.
    • Prevent symptomatic disease in HIGH RISK individuals (81% effective).

 

Click on BOLD links for more information

Monoclonal Antibody Treatment – Casirivimab and Imdevimab

  • Laboratory made
  • SARS-COV-2 Spike Protein
  • Block viral detachment and entry into cells

FDA Emergency Use Authorization (EUS) News Release Nov. 21, 2020

Provider Fact Sheet

Patient Fact Sheet

HHS Casirivimab/Imdevimab Allocation Dashboard 

Who – early intervention

  • Mild to moderate symptoms
    • Older than 65 yo
    • high risk due to complicating factors
  • Pediatric
    • 12 yo or older
    • Greater then 85lbs
  • Not hospitalized patients
  • Not patients on supplemental O2

How 

  • IV
  • Single dose 2,400mg
  • Within 3 days of positive COVID test

Outcomes 799 patients

  • Day 7 viral load reduction
    • Day 7 viral load correlates with severity of illness
  • 3 times less hospitalizations (3% vs 9%)
  • 3 times less ER visits

NEJM Oct 29, 2020  SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19 

  • 467 patients
    • 317 treatment
    • 150 controls
  • Symptoms
    • Lower in treated group
  • Hospitalizations
    • 4% vs 15% in high risk patients
    • 1.6% vs 6.3% overall
  • Lower symptoms scores
  • Safety
    • No serious adverse effects
    • Minor adverse effects no greater than control group

NIH Comment Dec 2020

  • At this time, there are insufficient data to recommend either for or against the use of casirivimab plus imdevimab for the treatment of outpatients with mild to moderate COVID-19.
  • The casirivimab plus imdevimab combination should not be considered the standard of care for the treatment of patients with COVID-19.
  • Health care providers are encouraged to discuss participation in SARS-CoV-2 neutralizing antibody clinical trials with patients who have mild to moderate COVID-19.
  • Casirivimab plus imdevimab should not be withheld from a pregnant individual who has a condition that poses a high risk of progression to severe COVID-19 if the clinician thinks that the potential benefit of the drug combination outweighs potential risk (see the criteria for EUA use of casirivimab plus imdevimab below).
  • Patients who are hospitalized for COVID-19 should not receive casirivimab plus imdevimab outside of a clinical trial.