NIH Updates COVID-19 Treatment Guidelines

The NIH today released a revised version of its Coronavirus Disease 2019 (COVID-19) Treatment Guidelines, in response to new data on SARS-CoV2, the virus that causes COVID-19 and on investigational treatments.

Key updates in this version include:

New: Antithrombotic Therapy in Patients with COVID-19

COVID-19 has been associated with inflammation and a prothrombotic state. Investigators have observed increases in fibrin, fibrin degradation products, fibrinogen, and D-dimers. There is currently no way to appreciate the incidecne of thrombosis, however, there have been a number of reports of increased rates of thromboembolic disease in COVID-19 patients treated in intensive care units.

This new section was added to address the many questions regarding the role of markers of coagulability and use of thrombolytic, anticoagulant, and antiplatelet agents in those with COVID-19. The Panel provides recommendations on antithrombotic agents to prevent VTE and guidance on management of incident thrombotic events when indicated.

Updated: Potential Antiviral Drugs Under Evaluation for the Treatment of COVID-19

Study descriptons in the section have been updated with publication status and assessment of a study's limitations and results, where available. All data included reflect changes to preprints and post-publication changes.

Recommendations added or revised:

Remdesivir: Based on prelinimary clincal trial data, the Panel recommends antiviral remdesivir for the treatment of COVID-19 in hospitalized patients with severe disease (ie, SpO2 ≤94% on ambient air [at sea level]), requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.

• Remdesivir is not approved by FDA but is available through an FDA EUA for 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).

Chloroquine: The Panel recommends against using high-dose chloroquine (600 mg twice daily for 10 days) for the treatment of COVID-19.

• This section now also includes FDA's warning against use of chloroquine or hydroxychloroquine for COVID-19 outside the setting of a hospital or clinical trial.

Immune-Based Therapy Under Evaluation for Treatment of COVID-19

Section Updated: Convalescent Plasma and 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.

Interleukin-6 Inhibitors: 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).

The guideline was initially published on April 21, 2020.

__________________________________________________________

For more COVID-19 coverage for primary care, visit our COVID-19 Resource Page.