What's New in the Guidelines
Last Updated: January 26, 2023
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 Guidelines Development for additional details on the development process).
Major revisions to the Guidelines within the past month are as follows:
January 26, 2023
On November 9, 2022, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the use of anakinra in certain hospitalized adults with COVID-19. The population of eligible patients described in the EUA is based on results from the SAVE-MORE trial. This trial enrolled patients with moderate or severe COVID-19 pneumonia and plasma levels of soluble urokinase plasminogen activator receptor (suPAR) ≥6 ng/mL, and patients who received anakinra had a lower risk of clinical progression of COVID-19 than those who received placebo. Because the assays that measure suPAR levels are not available in the United States, the FDA developed a scoring system that uses common clinical and laboratory factors to identify patients who are likely to have suPAR levels ≥6 ng/mL. The EUA allows for the use of anakinra in patients who meet ≥3 of these criteria.
The Panel continues to note that there is insufficient evidence to recommend either for or against the use of anakinra for the treatment of COVID-19. Data from randomized trials have not consistently demonstrated a benefit of anakinra in patients with COVID-19. In addition, suPAR assays are not available in the United States, and the scoring system that the FDA developed to identify patients who might have high suPAR levels requires further validation.
Minor Updates to the Guidelines
Minor updates were made to the following Guidelines sections:
January 10, 2023
The COVID-19 Treatment Guidelines Panel’s Statement on Tixagevimab Plus Cilgavimab (Evusheld) as Pre-Exposure Prophylaxis of COVID-19
In the United States, the prevalence of subvariants likely to be resistant to tixagevimab plus cilgavimab (Evusheld) is more than 91%. Although tixagevimab plus cilgavimab is still authorized by the FDA for COVID-19 pre-exposure prophylaxis (PrEP), it is unlikely to be effective at preventing COVID-19 in the vast majority of individuals. However, no alternative options for PrEP are available, and clinicians could still administer tixagevimab plus cilgavimab after considering an individual patient’s risks and the regional prevalence of the resistant subvariants.
December 28, 2022
Updates Regarding the Use of Bebtelovimab
Due to the increasing prevalence of SARS-CoV-2 Omicron subvariants that are anticipated to be resistant to bebtelovimab (i.e., BQ.1, BQ.1.1, XBB), bebtelovimab is not currently authorized by the FDA for the treatment of COVID-19 in any region of the United States. The Panel recommends against the use of bebtelovimab for the treatment of nonhospitalized patients with COVID-19 who are at high risk of progressing to severe COVID-19 (AIII).
In this update, several sections of the Guidelines have been revised to reflect this recommendation. These sections include: