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Immunomodulators Under Evaluation for the Treatment of COVID-19

Last Updated: April 21, 2021

Summary Recommendations
Summary Recommendations

See Therapeutic Management of Patients with COVID-19 for the COVID-19 Treatment Guidelines Panel’s (the Panel’s) recommendations on the use of the following:

  • Baricitinib in combination with remdesivir when corticosteroids cannot be used,
  • Dexamethasone (or other corticosteroids) with or without remdesivir, and
  • Tocilizumab with dexamethasone (with or without remdesivir).

See additional recommendations on the use of baricitinib and tocilizumab below.

Other Immunomodulators

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

  • Baricitinib in combination with a corticosteroid; because both agents are potent immunosuppressants, there is a potential additive risk of infection.
  • Baricitinib in combination with remdesivir for hospitalized patients with COVID-19 when corticosteroids can be used
  • Colchicine for nonhospitalized patients with COVID-19
  • Fluvoxamine
  • 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)
  • Tocilizumab for most hospitalized patients with hypoxemia who require conventional oxygen therapy (see Therapeutic Management of Adults With COVID-19 for more detailed information)

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

  • Baricitinib without remdesivir (AIII)
  • Colchicine for hospitalized patients with COVID-19 (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 supplemental oxygen administered through a high-flow device (BIIa)
  • The anti-IL-6 monoclonal antibody siltuximab (AIII)
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