NIH updates COVID-19 treatment guidelines

Evidence-based recommendations

January 2022
NIH updates COVID-19 treatment guidelines

 NIH updates COVID-19 treatment guidelines

The National Institutes of Health has made significant updates to its guidelines on treating people with COVID-19. Among the changes:

  • There is insufficient evidence to recommend for or against the use of colchicine in non-hospitalized patients. For hospitalized patients, colchicine is not recommended.
     
  • There is not enough evidence to make a recommendation for or against the use of fluvoxamine.
     
  • The guidelines include information on variants of interest and their in vitro susceptibility to various monoclonal antibodies.
     
  • The document also includes a new section on detection, classification and management of patients with mild to moderate COVID-19.

Updates to the guidelines 
Last updated: April 21, 2021

The coronavirus disease 2019 (COVID-19) treatment guidelines are published in an electronic format that can be updated to keep pace with the rapid pace and increasing volume of information on the treatment of COVID-19.

The COVID-19 Treatment Guidelines Panel is committed to updating this document to ensure that healthcare providers, patients, and policy experts have the latest information on the optimal management of COVID-19.

Working groups of Panel members develop new guideline sections and recommendations and updates to existing guideline sections. All recommendations included in the Guidelines are supported by the majority of Panel members.

The main revisions to the Guidelines made during the last month are as follows:

New sections of the guidelines 
Ambulatory management of acute COVID-19

In this section, the panel provides recommendations for the detection, triage, and therapeutic management of patients with mild to moderate COVID-19 who do not require hospitalization. This section also provides recommendations for the management of patients with COVID-19 after they are discharged from the emergency department or hospital.

Outpatient management of acute COVID-19 should include providing supportive care, taking measures to reduce the risk of SARS-CoV-2 transmission (including patient isolation), and advising patients on when to contact a healthcare provider. and find a doctor in person. evaluation (AIII).

Patients with COVID-19 symptoms should be triaged , when possible, through telehealth visits before receiving in-person care. Patients with dyspnea should be referred for in-person evaluation by a healthcare provider and should be followed closely for the first few days after the onset of dyspnea to assess for worsening respiratory status (AIII).

Management plans should be based on the patient’s vital signs, physical examination findings, risk factors for progression to serious illness, and availability of healthcare resources (AIII).

Specific therapy for outpatients with mild to moderate COVID-19

The COVID-19 Treatment Guidelines Panel (the Panel) recommends the use of one of the following combinations of anti-SARS-CoV-2 monoclonal antibodies to treat outpatients with mild to moderate COVID-19 who are at high risk of clinical progression, as defined by the Emergency Use Authorization Criteria (treatments are listed in alphabetical order):

  • Bamlanivimab 700 mg plus etesevimab 1,400 mg (AIIa); either
  • Casirivimab 1200 mg plus imdevimab 1200 mg (AIIa).

The Panel does not recommend the use of chloroquine or hydroxychloroquine with or without azithromycin (AI). There is insufficient data for the Panel to recommend for or against the use of other agents for the treatment of outpatients with COVID-19.

The Panel does not recommend the use of dexamethasone or other systemic glucocorticoids in outpatients in the absence of another indication (AIII). Currently, there is a lack of safety and efficacy data on the use of these agents in outpatients with COVID-19, and systemic glucocorticoids may cause harm in these patients.

The Panel does not recommend the use of antibacterial therapy (e.g., azithromycin, doxycycline) in the absence of another indication (AIII).

Healthcare providers should provide information about ongoing clinical trials of investigational therapies to eligible outpatients with COVID-19 so they can make informed decisions about clinical trial participation (AIII).

Recommendations rating: A = Strong; B = moderate; C = optional 
Evidence rating: I = one or more randomized trials without important limitations; IIa = Other randomized trials or subgroup analysis of randomized trials; IIb = non-randomized trials or observational cohort studies; III = Expert opinion

Colchicine

Based on the results of a large, randomized, placebo-controlled trial in outpatients with COVID-19, the Panel has determined that there are insufficient data to recommend the use of colchicine for or against the use of colchicine in patients without hospitalized with COVID-19. The Panel does not recommend the use of colchicine in hospitalized patients, except in a clinical trial (AIII).

Fluvoxamine

Based on the results of a small randomized controlled trial and an observational study, the Panel has determined that there is insufficient data to recommend for or against the use of fluvoxamine for the treatment of COVID-19.

Key Updates to 
Therapeutic Management of Adults with COVID-19 Guidelines

This section has been updated to incorporate recommendations on when to use the combination of anti-SARS-CoV-2 monoclonal antibodies and tocilizumab (in combination with dexamethasone) in certain patients with COVID-19. This section also includes a detailed discussion of the rationale behind these recommendations.

COVID-19 Overview

A new subsection has been added to discuss emerging information on SARS-CoV-2 variants of concern.

Clinical spectrum of SARS-CoV-2 infection

A new subsection describes reports of SARS-CoV-2 reinfection in people who had previously documented COVID-19. The discussion on patients experiencing persistent symptoms or organ dysfunction after acute COVID-19 was also updated.

Anti-SARS-CoV-2 monoclonal antibodies

This section now incorporates information and recommendations from the Panel Statement on the Emergency Use Authorization of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment of COVID-19 that was published on April 8, 2021. This section also includes Information on the various reported SARS-CoV-2 variants and the potential impact of the mutations on in vitro susceptibility to different anti-SARS-CoV-2 monoclonal antibodies.

Convalescent plasma

High-titer convalescent plasma is available through an Emergency Use Authorization from the Food and Drug Administration for the treatment of certain hospitalized patients with COVID-19. This section has been updated to include new recommendations regarding the use of convalescent plasma in hospitalized patients with COVID-19 (including those who have impaired humoral immunity) and in non-hospitalized patients with COVID-19. A new clinical data table summarizes the results of several randomized clinical trials and retrospective cohort studies of convalescent plasma use in patients with COVID-19.

Interleukin-6 inhibitors (with special attention to tocilizumab)

This section has been updated to incorporate and expand on the Panel’s statements on the use of tocilizumab for the treatment of COVID-19 that were published on February 3 and March 5, 2021. This section includes considerations for the use of tocilizumab in combination with dexamethasone in certain hospitalized patients experiencing rapid respiratory decompensation due to COVID-19. A new clinical data table summarizes the results of key studies on the use of tocilizumab and sarilumab in patients with COVID-19 that have had the greatest impact on the Panel’s recommendations.

Special considerations in children

This section now includes expanded discussions on treatment considerations for children with acute COVID-19. Additions to the section include updated information on the epidemiology and risk factors of COVID-19 in children, vertical transmission of SARS-CoV-2 infection, and multisystem inflammatory syndrome in children (MIS-C).

NIH updates COVID-19 treatment guidelines

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