Last Updated: August 17, 2021
The Coronavirus Disease 2019 (COVID-19) Treatment Guidelines is published in an electronic format that can be updated in step with the rapid pace and growing volume of information regarding the treatment of COVID-19.
The COVID-19 Treatment Guidelines Panel (the Panel) is committed to updating this document to ensure that health care providers, patients, and policy experts have the most recent information regarding the optimal management of COVID-19 (see the Panel Roster for a list of Panel members).
New Guidelines sections and recommendations and updates to existing Guidelines sections are developed by working groups of Panel members. All recommendations included in the Guidelines are endorsed by a majority of Panel members (see the Introduction for additional details on the Guidelines development process).
Major revisions to the Guidelines within the last month are as follows:
August 17, 2021
The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Casirivimab Plus Imdevimab as Post-Exposure Prophylaxis for SARS-CoV-2 Infection
Vaccination remains the most effective way to prevent SARS-CoV-2 infection. However, despite widespread availability of SARS-CoV-2 vaccines, a number of individuals are either not fully vaccinated or cannot mount adequate responses to the vaccine. Some of these people, if infected, are at high risk of progression to serious COVID-19. On July 30, 2021, the Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) indication for the anti-SARS-CoV-2 monoclonal antibodies casirivimab plus imdevimab to allow this combination to be used as post-exposure prophylaxis (PEP) for selected individuals, as described below.
The Panel recommends using casirivimab 600 mg plus imdevimab 600 mg administered as subcutaneous injections (AI) or an intravenous infusion (BIII) as PEP for people who are at high risk for progression to severe COVID-19 if infected with SARS-CoV-2 AND who have the following vaccination status AND exposure history:
Not fully vaccinated (defined as people who were never vaccinated or those who received the second vaccine dose in a two-dose series or a single-dose vaccine <2 weeks ago); or
Fully vaccinated, but not expected to mount an adequate immune response (e.g., those with immunocompromising conditions, including those who are taking immunosuppressive medications)
Exposure History to SARS-CoV-2:
Had a recent exposure to an individual with SARS-CoV-2 infection that is consistent with the Centers for Disease Control and Prevention close contact criteria; or
At high risk of exposure to an individual with SARS-CoV-2 infection because of recent occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (e.g., nursing homes, prisons)
The Panel’s statement includes additional recommendations on the use of casirivimab plus imdevimab and a detailed discussion of the clinical data that support these recommendations.
August 4, 2021
Key Updates to the Guidelines
This section has been updated to incorporate information that was previously included in the Panel’s anti-SARS-CoV-2 monoclonal antibody statements. The changes to this section include:
Adding sotrovimab as a recommended treatment for nonhospitalized patients with mild to moderate COVID-19 who are at high risk for clinical progression.
Revising the dosing and administration information for casirivimab plus imdevimab.
Recommending against the use of bamlanivimab plus etesevimab at this time because the Gamma (P.1) and Beta (B.1.351) variants of concern (VoC), which have reduced susceptibility to both agents, are circulating in the United States.
Discussing the FDA’s decision to revise the EUAs for anti-SARS-CoV-2 monoclonal antibodies to include a broader range of conditions that place patients at high risk for clinical progression.
Clarifying and updating the discussion on using anti-SARS-CoV-2 monoclonal antibodies in patients who are hospitalized for severe COVID-19.
Updating the information on the in vitro susceptibility of circulating VoC and variants of interest to different anti-SARS-CoV-2 monoclonal antibodies, as well as the potential activities of these antibodies against these variants. The Panel has also added a new table to the section to summarize this information.
This section now includes a discussion on the use of inhaled corticosteroids in nonhospitalized patients with COVID-19. Based on available clinical trial data, the Panel has determined that there is currently insufficient evidence to recommend either for or against the use of inhaled budesonide for the treatment of COVID-19.