Coronavirus Disease 2019 (COVID-19) Treatment Guidelines

1 Coronavirus Disease 2019 ( covid -19) Treatment GuidelinesCOVID-19 Treatment GuidelinesHow to Cite the covid -19 Treatment Guidelines : covid -19 Treatment Guidelines Panel. Coronavirus Disease 2019 ( covid -19) Treatment Guidelines . National Institutes of Health. Available at Accessed [insert date].The covid -19 Treatment Guidelines Panel regularly updates the recommendations in these Guidelines as new information on the management of covid -19 becomes available. The most recent version of the Guidelines can be found on the covid -19 Treatment Guidelines website ( ).Credit NIAID-RMLD ownloaded from on 1/19/2022 Visit to access the most up-to-date from on 1/19/2022 covid -19 Treatment Guidelines 2 Table of ContentsWhat s New in the Guidelines ..5 The covid -19 Treatment Guidelines Panel s Statement on Tixagevimab Plus Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis for SARS-CoV-2 Infection.

2 8 The covid -19 Treatment Guidelines Panel s Statement on Anticoagulation in Hospitalized Patients With covid -19 ..11 The covid -19 Treatment Guidelines Panel s Statement on Therapies for High-Risk, Nonhospitalized Patients With Mild to Moderate covid -19 ..14 The covid -19 Treatment Guidelines Panel s Statement on Potential Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications ..22 The covid -19 Treatment Guidelines Panel s Interim Statement on Patient Prioritization for Outpatient Anti-SARS-CoV-2 Therapies or Preventive Strategies When There Are Logistical or Supply Constraints ..26 Introduction ..29 Overview of covid -19 ..32 Testing for SARS-CoV-2 Infection ..37 Prevention of SARS-CoV-2 Infection ..43 Clinical Spectrum of SARS-CoV-2 Infection.

3 52 Clinical Management Summary ..61 General Management of Nonhospitalized Patients with Acute covid -19 ..64 Therapeutic Management of Nonhospitalized Adults With covid -19 ..71 Therapeutic Management of Hospitalized Adults With covid -19 ..77 Care of Critically Ill Adult Patients With covid -19 ..90 General Considerations ..92 Infection Control ..100 Hemodynamics ..103 Oxygenation and Ventilation ..107 Acute Kidney Injury and Renal Replacement Interventions ..116 Extracorporeal Membrane Oxygenation ..117 Antiviral Drugs That Are Approved or Under Evaluation for the Treatment of covid -19 .119 Remdesivir ..121 Table 2a. Remdesivir: Selected Clinical Data ..125 Chloroquine or Hydroxychloroquine and/or Azithromycin ..130 Table 2b. Chloroquine or Hydroxychloroquine and/or Azithromycin: Selected Clinical Data.

4 134 Interferons ..144 Table 2c. Interferons: Selected Clinical Data ..146 Downloaded from on 1/19/2022 covid -19 Treatment Guidelines 3 Ivermectin ..152 Table 2d. Ivermectin: Selected Clinical Data ..157 Lopinavir/Ritonavir and Other HIV Protease Inhibitors ..166 Nitazoxanide ..171 Table 2e. Nitazoxanide: Selected Clinical Data ..173 Table 2f. Characteristics of Antiviral Agents ..176 Anti-SARS-CoV-2 Antibody Products ..180 Anti-SARS-CoV-2 Monoclonal Antibodies ..181 Table 3a. Anti-SARS-CoV-2 Monoclonal Antibodies: Selected Clinical Data ..190 Convalescent Plasma ..193 Table 3b. covid -19 Convalescent Plasma: Selected Clinical Data ..200 Immunoglobulins: SARS-CoV-2-Specific ..207 Table 3c. Characteristics of SARS-CoV-2 Antibody-Based Products ..208 Cell-Based Therapy Under Evaluation for the Treatment of covid -19.

5 212 Immunomodulators Under Evaluation for the Treatment of ..216 Corticosteroids ..221 Table 4a. Systemic Corticosteroids: Selected Clinical Data ..228 Table 4b. Inhaled Corticosteroids: Selected Clinical Data ..234 Fluvoxamine ..238 Table 4c. Fluvoxamine: Selected Clinical Data ..241 Granulocyte-Macrophage Colony-Stimulating Factor Inhibitors ..244 Table 4d. Granulocyte-Macrophage Colony-Stimulating Factor Inhibitors: Selected Clinical Data ..247 Immunoglobulins: Non-SARS-CoV-2-Specific ..251 Interleukin-1 Inhibitors ..253 Interleukin-6 Inhibitors ..259 Table 4e. Interleukin-6 Inhibitors: Selected Clinical Data ..265 Kinase Inhibitors: Janus Kinase Inhibitors and Bruton s Tyrosine Kinase Inhibitors ..272 Table 4f. Characteristics of Immunomodulators ..280 Antithrombotic Therapy in Patients with covid -19.

6 292 Supplements ..301 Vitamin C ..302 Vitamin D ..305 Zinc ..307 Considerations for Using Concomitant Medications in Patients With covid -19 ..311 covid -19 and Special Populations ..313 Downloaded from on 1/19/2022 covid -19 Treatment Guidelines 4 Special Considerations in Pregnancy ..314 Special Considerations in Children ..319 Special Considerations in Adults and Children With Cancer ..330 Special Considerations in Solid Organ Transplant, Hematopoietic Stem Cell Transplant, and Cellular Immunotherapy Candidates, Donors, and Recipients ..339 Special Considerations in People With HIV ..347 Influenza and covid -19 ..354 Appendix A, Table 1. covid -19 Treatment Guidelines Panel Members ..359 Appendix A, Table 2. Panel on covid -19 Treatment Guidelines Financial Disclosure for Companies Related to covid -19 Treatment or Diagnostics.

7 361 Downloaded from on 1/19/2022 covid -19 Treatment Guidelines 5 What s New in the GuidelinesLast Updated: January 19, 2022 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 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).

8 Major revisions to the Guidelines within the last month are as follows:January 19, 2022 The covid -19 Treatment Guidelines Panel s Statement on Therapies for High-Risk, Nonhospitalized Patients With Mild to Moderate covid -19 The Panel has updated this statement to address the fact that the (Omicron) variant of concern (VOC) is now the dominant SARS-CoV-2 variant in the United States. Because the anti-SARS-CoV-2 monoclonal antibodies (mAbs) bamlanivimab plus etesevimab and casirivimab plus imdevimab are predicted to have markedly reduced activities against this VOC, and because real-time testing to identify rare, non-Omicron variants is not routinely available, the Panel recommends against the use of these anti-SARS-CoV-2 mAbs (AIII).January 5, 2022 The covid -19 Treatment Guidelines Panel s Statement on Tixagevimab Plus Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis for SARS-CoV-2 InfectionOn December 8, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the mAbs tixagevimab plus cilgavimab (Evusheld).

9 The EUA allows this combination to be used as pre-exposure prophylaxis (PrEP) in certain individuals who, if infected, are at high risk of progressing to severe covid -19. The Panel recommends using tixagevimab plus cilgavimab as SARS-CoV-2 PrEP for adults and adolescents (aged 12 years and weighing 40 kg) who do not have SARS-CoV-2 infection, who have not been recently exposed to an individual with SARS-CoV-2 infection, AND who: Are moderately to severely immunocompromised and may have an inadequate immune response to covid -19 vaccination (BIIa); or Are not able to be fully vaccinated with any available covid -19 vaccines due to a documented history of severe reactions to a covid -19 vaccine or any of its components (AIIa). The statement includes a list of moderately or severely immunocompromising conditions that will qualify an individual to receive tixagevimab plus cilgavimab as SARS-CoV-2 PrEP under the EUA.

10 It also includes a detailed discussion of the clinical data that support the from on 1/19/2022 covid -19 Treatment Guidelines 6 The covid -19 Treatment Guidelines Panel s Statement on Anticoagulation in Hospitalized Patients With covid -19 Several randomized controlled trials have evaluated the role of therapeutic doses of heparin in reducing venous thromboembolism or mortality in patients hospitalized for covid -19. This statement includes the Panel s recommendations on the use of anticoagulation therapy in hospitalized, nonpregnant adults with covid -19 who are receiving supplemental oxygen. These recommendations are presented according to whether the patient is receiving intensive care unit level of statement includes additional recommendations on the use of anticoagulation therapy in pregnant adults with covid -19 and discusses the clinical data supporting the Panel s 30, 2021 The covid -19 Treatment Guidelines Panel s Statement on Therapies for High-Risk, Nonhospitalized Patients With Mild to Moderate covid -19 The FDA recently issued EUAs that allow 2 oral antiviral agents to be used as treatments for covid -19 in nonhospitalized patients with mild to moderate covid -19 who are at high risk of progressing to serious Disease : ritonavir-boosted nirmatrelvir (Paxlovid) and molnupiravir.