What's New in the Guidelines
Last Updated: November 2, 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:
November 2, 2023
Ritonavir-Boosted Nirmatrelvir (Paxlovid) Update
In May 2023, the Food and Drug Administration (FDA) approved the use of ritonavir-boosted nirmatrelvir (Paxlovid) for the treatment of certain adults with COVID-19. However, ritonavir-boosted nirmatrelvir was initially only available from Emergency Use Authorization (EUA) supplies, and its use was constrained by the terms and conditions of the EUA.
Beginning November 1, 2023, distribution of EUA-labeled ritonavir-boosted nirmatrelvir by the U.S. government will transition to distribution of commercially available, FDA-approved ritonavir-boosted nirmatrelvir by Pfizer. There will be a period of time during which both the EUA-labeled and FDA-approved packaged products will be available for use. Ritonavir-boosted nirmatrelvir is still available through an FDA EUA for the treatment of mild to moderate COVID-19 in nonhospitalized adolescents aged 12 to 17 years and weighing ≥40 kg.
The Panel updated the following sections of the Guidelines to reflect this change:
- Therapeutic Management of Nonhospitalized Adults With COVID-19
- Antiviral Agents, Including Antibody Products
- Ritonavir-Boosted Nirmatrelvir (Paxlovid)
- Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications
- COVID-19 Convalescent Plasma
- Table 4e
- Special Considerations in People Who Are Immunocompromised
- Special Considerations in Adults and Children With Cancer
- Special Considerations in Solid Organ Transplant, Hematopoietic Cell Transplant, and Cellular Immunotherapy Candidates, Donors, and Recipients
- Special Considerations in People With HIV
October 10, 2023
New Sections in the Guidelines
Two new sections, Abatacept and Infliximab, were added to the Guidelines to discuss the available clinical data on the use of these agents to treat certain hospitalized patients with COVID-19. The Panel’s recommendations for using these agents to treat COVID-19 are provided in Therapeutic Management of Hospitalized Adults With COVID-19.
Key Updates to the Guidelines
Certain hospitalized patients with COVID-19 who require supplemental oxygen but do not require mechanical ventilation or extracorporeal membrane oxygenation should receive dexamethasone in combination with another immunomodulator. Baricitinib or tocilizumab are the preferred options for this second immunomodulator; however, either intravenous (IV) abatacept (CIIa) or IV infliximab (CIIa) can be used as alternatives. The rationale for these recommendations is based on results from the ACTIV-1 trial.
The Panel updated the recommendation on the use of tofacitinib and sarilumab for the treatment of COVID-19 in certain hospitalized adults and noted that oral tofacitinib (CIIa) or IV sarilumab (CIIa) should only be used in combination with dexamethasone if baricitinib, tocilizumab, abatacept, or infliximab are not available or feasible to use.
New data regarding the use of remdesivir to treat certain hospitalized patients with COVID-19 who are immunocompromised have been added to the section.
The Panel revised the following sections to reflect the changes in Therapeutic Management of Hospitalized Adults With COVID-19:
The Panel has updated the recommendation for nonhospitalized patients with COVID-19 in this section. There is currently insufficient evidence to recommend either for or against the use of metformin in these patients. The Panel also added information about a secondary endpoint from the COVID-OUT study to the text and clinical data table for this section. This study reported a lower rate of hospitalization or death at Day 28 among patients with COVID-19 who received metformin than among those who received placebo. Because the TOGETHER trial did not show a benefit of metformin in symptomatic, nonhospitalized patients with COVID-19, the Panel noted that the trial results do not consistently show a benefit of using metformin in this population.
The Panel revised the recommendation on the use of an intermediate dose of anticoagulation for venous thromboembolism prophylaxis in hospitalized patients with COVID-19 who require intensive care unit-level care. This change is based on results from the recently published ANTICOVID trial. This study evaluated net clinical outcome among the participants, which was defined as a composite of venous and arterial thrombosis, major bleeding events, or all-cause mortality by Day 28. The study reported that a smaller percentage of patients who received an intermediate dose of low-molecular-weight heparin (LMWH) met the net clinical outcome criteria compared with those who received a prophylactic dose. Because the INSPIRATION trial did not show a benefit in patients who received an intermediate dose of LMWH, the Panel noted that the trial results do not consistently show a benefit of using an intermediate dose of LMWH in this population.
Minor Updates to the Guidelines
Minor updates were made to the following Guidelines sections: