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Immunomodulators Under Evaluation for the Treatment of COVID-19

Last Updated: July 8, 2021

Summary Recommendations
Summary Recommendations

See Therapeutic Management of Hospitalized Patients with COVID-19 for the COVID-19 Treatment Guidelines Panel’s (the Panel) recommendations on the use of the following immunomodulators for patients with a specified disease severity:

  • Baricitinib with dexamethasone,
  • Dexamethasone, and
  • Tocilizumab with dexamethasone.

Additional Recommendations

There is insufficient evidence for the Panel to recommend either for or against the use of the following immunomodulators for the treatment of COVID-19:

  • Colchicine for nonhospitalized patients
  • Fluvoxamine
  • Granulocyte-macrophage colony-stimulating factor inhibitors for hospitalized patients
  • Interleukin (IL)-1 inhibitors (e.g., anakinra)
  • Interferon beta for the treatment of early (i.e., <7 days from symptom onset) mild to moderate COVID-19
  • Sarilumab for patients who are within 24 hours of admission to the intensive care unit (ICU) and who require invasive mechanical ventilation, noninvasive ventilation, or high-flow oxygen (>0.4 FiO2/30 L/min of oxygen flow)

The Panel recommends against the use of the following immunomodulators for the treatment of COVID-19, except in a clinical trial:

  • Baricitinib with tocilizumab (AIII)
  • Interferons (alfa or beta) for the treatment of severely or critically ill patients with COVID-19 (AIII)
  • Kinase inhibitors:
    • Bruton’s tyrosine kinase inhibitors (e.g., acalabrutinib, ibrutinib, zanubrutinib) (AIII)
    • Janus kinase inhibitors other than baricitinib (e.g., ruxolitinib, tofacitinib) (AIII)
  • Non-SARS-CoV-2-specific intravenous immunoglobulin (IVIG) (AIII). This recommendation should not preclude the use of IVIG when it is otherwise indicated for the treatment of complications that arise during the course of COVID-19.
  • Sarilumab for patients who do not require ICU-level care or who are admitted to the ICU for >24 hours but do not require invasive mechanical ventilation, noninvasive ventilation, or high-flow oxygen (BIIa)
  • The anti-IL-6 monoclonal antibody siltuximab (BIII)

The Panel recommends against using colchicine for the treatment of COVID-19 in hospitalized patients (AI).

Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials without major limitations; IIa = Other randomized trials or subgroup analyses of randomized trials; IIb = Nonrandomized trials or observational cohort studies; III = Expert opinion