What's New in the Guidelines

Last Updated: August 4, 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 4, 2021

Key Updates to the Guidelines

Anti-SARS-CoV-2 Monoclonal Antibodies

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 Food and Drug Administration’s decision to revise the Emergency Use Authorizations 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.

Corticosteroids

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.

July 8, 2021

New Sections of the Guidelines

General Management and Therapeutic Management of Nonhospitalized Patients

Outpatient Management of Acute COVID-19 has been divided into two sections:

A new figure has been created for Therapeutic Management of Nonhospitalized Adults With COVID-19 to provide guidance on the use of therapeutic agents (e.g., anti-SARS-CoV-2 monoclonal antibodies) based on the patient’s disposition.

Nitazoxanide

This section has been added to discuss the evidence and considerations for using nitazoxanide as an antiviral drug for the treatment of COVID-19. The Panel recommends against the use of nitazoxanide for the treatment of COVID-19, except in a clinical trial (BIIa).

Granulocyte-Macrophage Colony-Stimulating Factor Inhibitors

This section has been added to address the use of granulocyte-macrophage colony-stimulating factor (GM-CSF) inhibitors as immunomodulators for the treatment of COVID-19. Based on the preliminary results from two, randomized, placebo-controlled trials investigating otilimab and lenzilumab, and a small, randomized, placebo-controlled trial of mavrilimumab, the Panel has determined that there is insufficient evidence to recommend either for or against the use of GM-CSF inhibitors for the treatment of hospitalized patients with COVID-19.

Key Updates to the Guidelines

Therapeutic Management of Hospitalized Adults with COVID-19

This section has been updated to incorporate new recommendations and rationale for when to use baricitinib in combination with dexamethasone in certain hospitalized patients with COVID-19. The update is based on results from the COV-BARRIER trial. The Panel recommends against the use of baricitinib in combination with tocilizumab (AIII).

Chloroquine or Hydroxychloroquine and/or Azithromycin

This section has been updated with new clinical data from multiple clinical trials. The recommendation for the use of these agents in nonhospitalized patients has been revised, and a recommendation regarding azithromycin monotherapy has been added.

Colchicine

A large, unpublished, randomized, placebo-controlled trial (RECOVERY) evaluated the role of colchicine in hospitalized patients with COVID-19. The study showed no difference in 28-day all-cause mortality between patients who received colchicine and those who received usual care. Based on these results, the Panel has updated its recommendation, and recommends against the use of colchicine for the treatment of hospitalized patients with COVID-19 (AI).

Special Considerations in Pregnancy

This section has been updated to include more recent epidemiologic data indicating that some pregnant people may be at increased risk of COVID-19. In general, the therapeutic management of COVID-19 should be the same for pregnant patients as for nonpregnant patients. Developing a treatment plan should involve shared decision-making between the patient and the clinical team, with considerations based on the severity of maternal disease and the safety of the medication for the pregnant individual and the fetus. Breastfeeding in the setting of COVID-19 is not contraindicated, and decision-making surrounding feeding breast milk while the patient is receiving therapeutic agents for COVID-19 is addressed. Updates to this section also include safety data on the use of COVID-19 vaccines during pregnancy.

Other Updates

The following sections have been updated with more current information:

Overview of COVID-19 (updated information on SARS-CoV-2 variants of concern and variants of interest)
Prevention and Prophylaxis of SARS-CoV-2 Infection (added information on vaccine-related adverse effects)
Hemodynamics (update on rationale for using norepinephrine as vasopressor of choice)
Ivermectin: Selected Clinical Data (additional clinical trial data)

Sections Under Revision

The following sections are currently under revision: