What's New in the Guidelines
Last Updated: November 18, 2020
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:
November 18, 2020
The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Bamlanivimab for the Treatment of COVID-19
On November 9, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) for the treatment of nonhospitalized patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. Based on the available data, the Panel has determined the following:
- At this time, there are insufficient data to recommend either for or against the use of bamlanivimab for the treatment of outpatients with mild to moderate COVID-19.
- Bamlanivimab should not be considered the standard of care for the treatment of patients with COVID-19.
- More data are needed to assess the impact of bamlanivimab on the disease course of COVID-19 and to identify those people who are most likely to benefit from the drug. Health care providers are encouraged to discuss participation in bamlanivimab clinical trials with their patients.
- Patients who are hospitalized for COVID-19 should not receive bamlanivimab outside of a clinical trial.
- Given the possibility of a limited supply of bamlanivimab, as well as challenges distributing and administering the drug, patients at highest risk for COVID-19 progression should be prioritized for use of the drug through the EUA. In addition, efforts should be made to ensure that communities most affected by COVID-19 have equitable access to bamlanivimab.
- The Panel will continue to evaluate emerging clinical data on the use of bamlanivimab for the treatment of outpatients with mild to moderate COVID-19 and anticipates updating these recommendations as more information becomes available.
November 3, 2020
Key Updates to the Guidelines
Remdesivir
On October 22, 2020, the FDA approved remdesivir for the treatment of hospitalized patients with COVID-19. Several Guidelines sections related to remdesivir (Antiviral Drugs That Are Approved or Under Evaluation for the Treatment of COVID-19, Remdesivir, Remdesivir: Selected Clinical Data, and Table 2) have been updated. The updated information includes:
- The addition of key information from the FDA product label and updates that correspond to changes to the remdesivir Emergency Use Authorization;
- The addition of a study description in the Remdesivir: Selected Clinical Data section; and
- Updates to remdesivir-related considerations in pregnancy.
The Panel’s recommendations for the use of remdesivir (with or without corticosteroids) based on disease severity and the rationale for each recommendation have been moved to the Therapeutic Management of Patients with COVID-19 section.
A number of sections of the Guidelines have been updated to remove statements indicating that no drugs have been approved by the FDA for the treatment of COVID-19.
Corticosteroids
This section has been updated to include summaries for a number of recently published studies on the use of corticosteroids for the treatment of patients with COVID-19. The Panel’s recommendations for the use of corticosteroids (with or without remdesivir) based on disease severity and the rationale for each recommendation have been moved to the Therapeutic Management of Patients with COVID-19 section.
Other Updates to the Guidelines
Testing for SARS-CoV-2 Infection
This section has been updated with additional information on who should be tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the diagnostic tests that are currently under investigation.
Vitamin C
This section has been updated with new clinical trial data on the use of vitamin C and thiamine (with or without hydrocortisone) in patients with severe pneumonia, sepsis, or septic shock.
October 22, 2020
New Section of the Guidelines
Influenza and COVID-19
This new section of the Guidelines provides information for clinicians when influenza viruses and SARS-CoV-2 are cocirculating in the community. It includes information on influenza vaccination for persons with COVID-19, influenza and SARS-CoV-2 testing in patients with acute respiratory symptoms, and treatment of influenza. Several treatment considerations for patients hospitalized with suspected or confirmed SARS-CoV-2 and influenza virus coinfection are also outlined in the section.