What's New in the Guidelines
Last Updated: September 1, 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:
September 1, 2020
The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Convalescent Plasma for the Treatment of COVID-19
The Food and Drug Administration issued an Emergency Use Authorization for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. Based on the available evidence, the Panel has determined the following:
- There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.
- Convalescent plasma should not be considered the standard of care for the treatment of patients with COVID-19.
- Prospective, well-controlled, adequately powered randomized trials are needed to determine whether convalescent plasma is effective and safe for the treatment of COVID-19. Members of the public and health care providers are encouraged to participate in these prospective clinical trials.
August 27, 2020
Key Updates to the Guidelines
To reflect the results of large randomized controlled trials that enrolled hospitalized patients, the following recommendations have been updated to differentiate between hospitalized and nonhospitalized patients:
- The Panel recommends against the use of chloroquine or hydroxychloroquine for the treatment of COVID-19 in hospitalized patients (AI).
- In nonhospitalized patients, the Panel recommends against the use of chloroquine or hydroxychloroquine for the treatment of COVID-19, except in a clinical trial (AI).
Preliminary, unpublished data from randomized controlled trials have not demonstrated the efficacy of sarilumab or tocilizumab in patients with COVID-19. The data on the efficacy of siltuximab in patients with COVID-19 are limited and come from unpublished studies. The Panel’s recommendation on using interleukin (IL)-6 inhibitors for the treatment of COVID-19 has been revised:
- The Panel recommends against the use of anti-IL-6 receptor monoclonal antibodies (e.g., sarilumab, tocilizumab) or an anti-IL-6 monoclonal antibody (siltuximab) for the treatment of COVID-19, except in a clinical trial (BI).
New Sections of the Guidelines
A new subsection was added to Potential Antiviral Drugs Under Evaluation for the Treatment of COVID-19 to address the use of ivermectin for the treatment of COVID-19. The Panel recommends against the use of ivermectin for the treatment of COVID-19, except in a clinical trial (AIII).
Patients who are receiving active treatment for cancer have a higher risk of severe complications from COVID-19 than patients without cancer. These complications include a greater risk of mortality and a greater likelihood of being admitted to the intensive care unit. This new section provides recommendations for screening asymptomatic cancer patients for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The Panel also emphasizes the importance of consulting a hematologist or oncologist before adjusting a patient’s cancer-directed therapy. Decisions about administering cancer-directed therapies to patients with SARS-CoV-2 infection should be made on a case-by-case basis; clinicians should consider the indication for chemotherapy, the goals of care, and the patient’s history of tolerance to the treatment.
Other Updates to the Guidelines
Table 2a has been removed from the guidelines. The summaries of the clinical data for each antiviral agent are now included in new subsections that can be found under the individual drug sections.
This section has been updated to include the most recent epidemiological data for COVID-19 in pregnant people in the United States. This section also provides additional guidance on maternal and fetal monitoring in hospitalized patients who are pregnant and who have received a diagnosis of COVID-19. The Panel recommends that potentially effective treatment for COVID-19 should not be withheld from pregnant women because of theoretical concerns related to safety during pregnancy (AIII).
The following sections have been updated to include new data from clinical trials and observational cohort studies: