Skip to main content
U.S. flag

An official website of the United States government

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Https

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Guideline PDFs

Sign up for updates

Related Content

Table 4c. Characteristics of Immunomodulators Under Evaluation for the Treatment of COVID-19

Last Updated: April 21, 2021

  • The information in this table is derived from data on the use of these drugs for FDA-approved indications or in investigational trials, and it is supplemented with data on their use in patients with COVID-19, when available.
  • For dose modifications for patients with organ failure or those who require extracorporeal devices, please refer to product labels, when available.
  • There are currently not enough data to determine whether certain medications can be safely coadministered with therapies for the treatment of COVID-19. When using concomitant medications with similar toxicity profiles, consider performing additional safety monitoring.
  • The potential additive, antagonistic, or synergistic effects and the safety of using certain combination therapies for the treatment of COVID-19 are unknown. Clinicians are encouraged to report AEs to the FDA Medwatch program.
  • For the Panel’s recommendations for the drugs listed in this table, please refer to the drug-specific sections of the Guidelines and to Therapeutic Management of Adults With COVID-19.
Table 4c. Characteristics of Immunomodulators Under Evaluation for the Treatment of COVID-19
Table 4c. Characteristics of Immunomodulators Under Evaluation for the Treatment of COVID-19

  1. Colchicine (Colcrys) [package insert]. Food and Drug Administration. 2009. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022351lbl.pdf.
  2. Randomised Evaluation of COVID-19 Therapy (RECOVERY). Low-cost dexamethasone reduces death by up to one third in hospitalised patients with severe respiratory complications of COVID-19. 2020. Available at: https://www.recoverytrial.net/news/low-cost-dexamethasone-reduces-death-by-up-to-one-third-in-hospitalised-patients-with-severe-respiratory-complications-of-covid-19. Accessed February 9, 2021.
  3. Stauffer WM, Alpern JD, Walker PF. COVID-19 and dexamethasone: a potential strategy to avoid steroid-related strongyloides hyperinfection. JAMA. 2020;Published online ahead of print. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32761166.
  4. Liu J, Wang T, Cai Q, et al. Longitudinal changes of liver function and hepatitis B reactivation in COVID-19 patients with pre-existing chronic HBV infection. Hepatol Res. 2020;50(11):1211-1221. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32761993.
  5. Centers for Disease Control and Prevention. Parasites—strongyloides: resources for health professionals. 2020. Available at: https://www.cdc.gov/parasites/strongyloides/health_professionals/index.html. Accessed April 8, 2021.
  6. Omrani AS, Saad MM, Baig K, et al. Ribavirin and interferon alfa-2a for severe Middle East respiratory syndrome coronavirus infection: a retrospective cohort study. Lancet Infect Dis. 2014;14(11):1090-1095. Available at: https://www.ncbi.nlm.nih.gov/pubmed/25278221.
  7. Shalhoub S, Farahat F, Al-Jiffri A, et al. IFN-alpha2a or IFN-beta1a in combination with ribavirin to treat Middle East respiratory syndrome coronavirus pneumonia: a retrospective study. J Antimicrob Chemother. 2015;70(7):2129-2132. Available at: https://www.ncbi.nlm.nih.gov/pubmed/25900158.
  8. Zhou Q, Chen V, Shannon CP, et al. Interferon-alpha2b treatment for COVID-19. Front Immunol. 2020;11:1061. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32574262.
  9. Peginterferon alfa-2a (Pegasys) [package insert]. Food and Drug Administration. 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf.
  10. Hung IF, Lung KC, Tso EY, et al. Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, Phase 2 trial. Lancet. 2020;395(10238):1695-1704. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32401715.
  11. Interferon beta-1a (Rebif) [package insert]. Food and Drug Administration. 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103780s5204lbl.pdf.
  12. Sarilumab (Kevzara) [package insert]. Food and Drug Administration. 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf.
  13. Regeneron and Sanofi provide update on U.S. Phase 2/3 adaptive-designed trial of KEVZARA® (sarilumab) in hospitalized COVID-19 patients. News release. Regeneron. 2020. Available at: https://investor.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-provide-update-us-phase-23-adaptive. Accessed: April 8, 2021.
  14. Tocilizumab (Actemra) [package insert]. Food and Drug Administration. 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s127,125472s040lbl.pdf.
  15. Lier AJ, Tuan JL, Davis MW, et al. Case report: disseminated strongyloidiasis in a patient with COVID-19. Am J Trop Med Hyg. 2020;103(4):1590-1592. Available at: https://pubmed.ncbi.nlm.nih.gov/32830642/.
  16. Marchese V, Crosato V, Gulletta M, et al. Strongyloides infection manifested during immunosuppressive therapy for SARS-CoV-2 pneumonia. Infection. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32910321.
  17. Siltuximab (Sylvant) [package insert]. Food and Drug Administration. 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125496s018lbl.pdf.
  18. Baricitinib (Olumiant) [package insert]. Food and Drug Administration. 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207924s001lbl.pdf.
  19. Food and Drug Administration. Fact sheet for healthcare providers: Emergency Use Authorization (EUA) of baricitinib. 2020. Available at: https://www.fda.gov/media/143823/download.

Guideline PDFs

Sign up for updates

Related Content