Module 1: COVID-19 Outpatient Therapeutics Overview

Who Is At Risk for Severe COVID-19?

COVID-19 Risk Continuum

Sociodemographic factors and non-pharmaceutical interventions affect exposure
Original illustration by Dr. William Werbel, adapted for the COVID-19 Real-Time Learning Network

For more information, refer to: CDC Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals

Summary of COVID-19 Preventative Agents & Treatments

# Be sure to check latest updates on inpatient care

¹ Convalescent Plasma EUA High titer convalescent plasma is authorized for specific immunocompromised patients.
² Refer to individual product Fact Sheets for authorization details

NIH Guidelines For Treatment of Mild to Moderate COVID-19 in Non-hospitalized Adults Who Are at High Risk of Progressing to Severe COVID-19

The COVID-19 Treatment Guidelines Panel (the Panel) recommends the following anti-SARS-CoV-2 therapies as preferred treatments for COVID-19.

These drugs are listed in order of preference:
- Nirmatrelvir co-packaged with ritonavir (Paxlovid) (AIIa)
- Remdesivir (Veklury) (BIIa)
Alternative therapy. For use when the preferred therapies are not available, feasible to use, or clinically appropriate.
- Molnupiravir (Lagevrio) (CIIa)

To learn more, refer to NIH COVID Treatment Guidelines: Antiviral Agents, Including Antibody Products

NIH: Patient Prioritization for Treatment

The NIH Prioritization Guidelines are for use only when logistical constraints limit the availability of therapies.
Remdesivir is a recommended option if nirmatrelvir co-packaged with ritonavir cannot be used.
Some treating facilities may not have the ability to provide a 3-day course of remdesivir intravenous infusions to all eligible patients. In these situations, prioritizing patients who will benefit the most from the therapy becomes necessary.
Prioritization strategy includes 4 factors: age, vaccination status, immune status, and clinical risk factors.

Tier	Risk Group
1	Immunocompromised individuals not expected to mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection due to their underlying conditions, regardless of vaccine status (see Immunocompromising Conditions below); or Unvaccinated individuals at the highest risk of severe disease (anyone aged ≥75 years or anyone aged ≥65 years with additional risk factors).
2	Unvaccinated individuals not included in Tier 1 who are at risk of severe disease (anyone aged ≥65 years or anyone aged <65 years with clinical risk factors)
3	Vaccinated individuals at risk of severe disease (anyone aged ≥65 years or anyone aged <65 years with clinical risk factors) Note: Vaccinated individuals who are not up to date with their immunizations are likely at higher risk for severe disease; patients within this tier who are in this situation should be prioritized for treatment.

Recommendations for Special Populations: Immunocompromised & Pediatrics

NIH Guidelines for Patients Who are Immunocompromised

All people who are moderately or severely immunocompromised should receive COVID-19 vaccination.
All close contacts of people who are immunocompromised are strongly encouraged to be up to date on vaccination against COVID-19.
There is insufficient evidence for recommendation for or against the use of SARS-CoV-2 serologic testing to assess for immunity or to guide clinical decision about using COVID-19 vaccines or PrEP for certain people.
Management of COVID-19 in individuals who are moderately to severely immunocompromised:
- Patients should be treated quickly with appropriate COVID-19 therapeutics.
- Decisions regarding stopping or reducing the doses of immunosuppressive drugs in patients with COVID-19 should be made in consultation with the appropriate specialists. When selecting treatments for COVID-19, clinicians should consider factors such as the underlying disease, the specific immunosuppressants being used, the potential for drug-drug interactions, and the severity of COVID-19.

For more information, refer to the Immunocompromised COVID-19 Treatment Guidelines

Therapeutics for Pediatric Patients < 12 Years Old

Veklury (Remdesivir) prescribing information
Pediatric patients 28 Days of Age and Older and weighing3 kg to less than 40 kg*

* Pediatric patients less than 12 years of age but weighing 40kg or greater receive Veklury at the adult dose

NIH Guidelines For Therapeutic Management in Non-hospitalized Children With COVID-19

Risk of Severed COVID-19	Panel's Recommendations
Risk of Severed COVID-19	Aged 12-17 years	Aged <12 years
Symptomatic, Regardless of Risk Factors	Provide supportive care (AIII).	Provide supportive care (AIII).
High Risk^a,b	Use 1 of the following options (listed in order of preference):^c Nirmatrelvir co-packaged with ritonavir (Paxlovid) within 5 days of symptom onset (BIII) Remdesivir within 7 days of symptom onset (CIII)	Nirmatrelvir co-packaged with ritonavir is not authorized by the FDA for use in children aged <12 years. There is insufficient evidence to recommend either for or against the routine use of remdesivir. Consider treatment based on age and other risk factors.
Intermediate Risk^b,d	There is insufficient evidence to recommend either for or against the use of any antiviral therapy. Consider treatment based on age and other risk factors.	There is insufficient evidence to recommend either for or against the routine use of remdesivir
Low Risk^b,e	Manage with supportive care alone (BIII).	Manage with supportive care alone (BIII).

a. Molnupiravir is not authorized by the FDA for use in children aged <18 years and should not be used.
b. See Table 3b for the Panel's framework for assessing the risk of progression to severe COVID-19 based on patient conditions and COVID-19 vaccination status.
c. Initiate treatment as soon as possible after symptom onset.
d. The relative risk of severe COVID-19 for intermediate-risk patients is lower than the risk for high-risk patients but higher than the risk for low-risk patients.
e. Low-risk patients include those with comorbid conditions that have a weak or unknown association with severe COVID-19. Patients with no comorbidities are included in this group.

For more information, refer to Therapeutic Management of Nonhospitalized Children With COVID-19

Module 1: COVID-19 Outpatient Therapeutics Overview

Who Is At Risk for Severe COVID-19?

COVID-19 Risk Continuum

Summary of COVID-19 Preventative Agents & Treatments

NIH Guidelines For Treatment of Mild to Moderate COVID-19 in Non-hospitalized Adults Who Are at High Risk of Progressing to Severe COVID-19

NIH: Patient Prioritization for Treatment

Recommendations for Special Populations: Immunocompromised & Pediatrics

NIH Guidelines for Patients Who are Immunocompromised

Therapeutics for Pediatric Patients < 12 Years Old

NIH Guidelines For Therapeutic Management in Non-hospitalized Children With COVID-19

Additional Tools to Assist in COVID-19 Outpatient Therapeutic Selection

Introduction

Module 1: COVID-19 Outpatient Therapeutics Overview

Module 2: Products for Treatment of Mild-to-Moderate COVID-19

Module 3: Oral Antiviral Administration

Module 4: Facilitating Patient Access

Module 5: Reimbursement

Module 6: Product Returns

Module 7: Additional Resources

Module 8: Appendices