Molnupiravir is Restricted: High-risk* outpatients > 18 years of age with mild-to-moderate COVID-19, Laboratory or home test confirmed COVID-19, Symptom onset ≤ 5 days, When other options are not available or cannot be used***

• For outpatient use only
  • Note: if patients are hospitalized after starting treatment, we recommend stopping therapy due to potential for drug-drug interactions and lack of benefit
• Patients must meet EUA criteria: for the treatment of mild-moderate COVID-19 in adults with positive direct SARS-CoV-2 testing and high risk of progression to severe COVID-19* and when other treatment options are unavailable due to relatively less reported efficacy (see NIH order of preference for COVID therapies)
  • *High risk for progression to severe disease: over 60 years of age, diabetes, obesity (BMI ≥30), chronic kidney disease, serious heart conditions, chronic obstructive pulmonary disease, or active cancer
• Inclusion criteria:
  • Laboratory confirmed COVID-19 ≤ 5 days
  • Symptom onset ≤ 5 days
  • Mild-moderate COVID-19 symptoms
  • Age ≥ 18 years old
  • Unvaccinated for COVID-19**
  • High risk for progression to severe disease
  • Assessment of pregnancy with low suspicion of current pregnancy in individuals of childbearing potential
• Exclusion criteria:
  • Pregnancy or unwillingness to use appropriate contraception during treatment (not breastfeeding – should be advised to pump/dump during and for 4 days after treatment)
  • Hospitalization for COVID-19 or expected to need hospitalization for COVID-19 within 48 hours
  • eGFR less than 30 ml/minute per 1.73 m² or HD
  • Severe neutropenia (absolute neutrophil count of <500 per milliliter)
  • Platelet count <100,000 per microliter
  • HIV w/ viral load > 50 copies/mL***
  • LFTs > 3x ULN
• Combining outpatient COVID-19 therapeutics is not currently recommended

  **Note: benefit of molnupiravir is unknown in vaccinated or previously infected patients.

  ***Consider HIV testing in high-risk patients, balance risk of potential development of HIV resistance with delaying therapy

See Ambulatory COVID Therapeutic Guidance

See Ambulatory COVID Treatment Order Form

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