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What's New in the Guidelines

Last Updated: December 3, 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:

December 3, 2020

Therapeutic Management of Patients with COVID-19

This section has been revised to include an Executive Summary with a more detailed discussion of the processes that are thought to drive the pathogenesis of COVID-19. These processes suggest that the effect of antiviral therapies will be greatest early in the course of COVID-19, whereas immunosuppressive/anti-inflammatory therapies are likely to have their greatest effect later in the course of the disease. Based on this understanding, the Panel updated Figure 1 to provide guidance on the use of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies, remdesivir, and dexamethasone in patients with different severities of disease.

December 2, 2020

The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of the Casirivimab Plus Imdevimab Combination for the Treatment of COVID-19

On November 21, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to make the casirivimab plus imdevimab combination available for the treatment of nonhospitalized patients with mild to moderate COVID-19 who are at high risk for progressing to severe disease and/or hospitalization. After reviewing the available evidence, the Panel has determined the following:

  • At this time, there are insufficient data to recommend either for or against the use of casirivimab plus imdevimab for the treatment of outpatients with mild to moderate COVID-19.
  • The casirivimab plus imdevimab combination should not be considered the standard of care for the treatment of patients with COVID-19.
  • Health care providers are encouraged to discuss participation in SARS-CoV-2 neutralizing antibody clinical trials with patients who have mild to moderate COVID-19.
  • Given the possibility of a limited supply of the casirivimab plus imdevimab combination, as well as challenges distributing and administering the drugs, patients at highest risk for COVID-19 progression should be prioritized for use of the drugs through the EUA. In addition, efforts should be made to ensure that the communities that are most affected by COVID-19 have equitable access to casirivimab plus imdevimab.
  • Casirivimab plus imdevimab should not be withheld from a pregnant individual who has a condition that poses a high risk of progression to severe COVID-19, if the clinician thinks that the potential benefit of the drugs outweighs the potential risk.
  • Patients who are hospitalized for COVID-19 should not receive casirivimab plus imdevimab outside of a clinical trial.
  • There are currently no comparative data to determine whether there are differences in clinical efficacy or safety between casirivimab plus imdevimab and bamlanivimab.

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 FDA issued an 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 EUA;
  • 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 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.