What's New in the Guidelines
Last Updated: May 12, 2020
New Section of the Guidelines
COVID-19 has been associated with inflammation and a prothrombotic state, with increases in fibrin, fibrin degradation products, fibrinogen, and D-dimers. Although the true incidence of thrombosis is unknown, there have been reports of increased incidence of thromboembolic disease associated with COVID-19 in patients in the intensive care unit.
A new section titled Antithrombotic Therapy in Patients with COVID-19 has been added to the guidelines to address many questions related to the role of coagulation markers and thrombolytic, anticoagulant, and antiplatelet agents in those with COVID-19. In this section, the COVID-19 Treatment Guidelines Panel (the Panel) provides recommendations on the use of antithrombotic agents for the prevention of venous thromboembolic events in hospitalized patients with COVID-19. In addition, the Panel recommends carefully monitoring, evaluating, and treating hospitalized patients with COVID-19 for incident thrombotic events when indicated.
Updates to the Guidelines
Throughout the section, study descriptions were updated to clearly indicate a study’s publication status and to provide an assessment of a study’s limitations and results. Data were also updated as needed based on changes to preprints or post-publication changes.
The following recommendations were added or revised in this section:
- On the basis of preliminary clinical trial data, the Panel recommends the investigational antiviral agent remdesivir for the treatment of COVID-19 in hospitalized patients with severe disease, defined as SpO2 ≤94% on ambient air (at sea level), requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (BI).
- Remdesivir is not approved by the Food and Drug Administration (FDA); however, it is available through an FDA emergency use authorization for the treatment of hospitalized adults and children with COVID-19. Remdesivir is also being investigated in clinical trials, and it is available through an emergency access program for children and pregnant patients.
- The Panel does not recommend remdesivir for the treatment of mild or moderate COVID-19 outside the setting of a clinical trial (AIII).
- The Panel recommends against using high-dose chloroquine (600 mg twice daily for 10 days) for the treatment of COVID-19 (AI), because the high dose carries a higher risk of toxicities than the lower dose.
- The FDA warning that cautioned against the use of chloroquine or hydroxychloroquine for COVID-19 outside the setting of a hospital or clinical trial was added to this section.
The following key changes were made to this section:
Convalescent Plasma and Immune Globulins:
- New information has been added to the section on convalescent plasma and SARS-CoV-2-specific immune globulins.
- A new section for non-SARS-CoV-2 intravenous immune globulin (IVIG) was created, in which the Panel recommends against the use of non-SARS-CoV-2-specific IVIG for the treatment of COVID-19, except in the context of a clinical trial (AIII). This should not preclude the use of IVIG when it is otherwise indicated for the treatment of complications that arise during the course of COVID-19.
- New data from an interim review of a Phase 2/3 clinical trial for sarilumab have been included.
- New preliminary results from a clinical trial for tocilizumab (CORIMUNO-TOCI) have been added.
- There is no change to the Panel’s recommendation for IL-6 inhibitors. There are insufficient data to recommend either for or against the use of IL-6 inhibitors (e.g., sarilumab, siltuximab, tocilizumab) for the treatment of COVID-19 (AIII).