Antiviral Drugs That Are Approved, Authorized, or Under Evaluation for the Treatment of COVID-19
Last Updated: April 29, 2022
Remdesivir is the only drug that is approved by the Food and Drug Administration (FDA) for the treatment of COVID-19. Ritonavir-boosted nirmatrelvir (Paxlovid), molnupiravir, and certain anti-SARS-CoV-2 monoclonal antibodies (mAbs) have received Emergency Use Authorizations from the FDA for the treatment of COVID-19.
This section focuses on the COVID-19 Treatment Guidelines Panel’s (the Panel) recommendations for using small-molecule antiviral drugs to treat COVID-19. These recommendations are based on the available data; for more information, see Table 2f. For recommendations and information regarding the use of anti-SARS-CoV-2 mAbs, see Anti-SARS-CoV-2 Monoclonal Antibodies and Table 3c.
Recommendations for Treating Nonhospitalized Patients
Recommendations for Treating Hospitalized Patients
Antiviral Drugs That the Panel Recommends Against
|Rating of Recommendations: A = Strong; B = Moderate; C = Weak|
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
Because SARS-CoV-2 replication leads to many of the clinical manifestations of COVID-19, antiviral therapies are being investigated for the treatment of COVID-19. These drugs prevent viral replication through various mechanisms, including blocking SARS-CoV-2 entry, inhibiting the activity of SARS-CoV-2 3-chymotrypsin-like protease (3CLpro) and RNA-dependent RNA polymerase (RdRp), and causing lethal viral mutagenesis.1-3 Because viral replication may be particularly active early in the course of COVID-19, antiviral therapy may have the greatest impact before the illness progresses to the hyperinflammatory state that can characterize the later stages of disease, including critical illness.4 For this reason, it is necessary to understand the role of antiviral medications in treating mild, moderate, severe, and critical illness in order to optimize treatment for people with COVID-19.
The following sections describe the underlying rationale for using different antiviral medications, provide the COVID-19 Treatment Guidelines Panel’s recommendations for using these medications to treat COVID-19, and summarize the existing clinical trial data. Additional antiviral therapies will be added to this section of the Guidelines as new evidence emerges.
- Food and Drug Administration. Fact sheet for healthcare providers: emergency use authorization for molnupiravir. 2022. Available at: https://www.fda.gov/media/155054/download.
- Food and Drug Administration. Fact sheet for healthcare providers: emergency use authorization for Paxlovid. 2022. Available at: https://www.fda.gov/media/155050/download.
- Remdesivir (Veklury) [package insert]. Food and Drug Administration. 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214787Orig1s000lbl.pdf.
- Siddiqi HK, Mehra MR. COVID-19 illness in native and immunosuppressed states: a clinical-therapeutic staging proposal. J Heart Lung Transplant. 2020;39(5):405-407. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32362390.