Outpatient COVID-19 Treatments: Information for Healthcare Providers

Updated July 12, 2022

The U.S. Food and Drug Administration (FDA) has authorized several widely-available therapeutics to treat mild-to-moderate COVID-19 in people who are at high-risk for progressing to severe COVID-19, and to prevent infection in moderate to severely immunocompromised patients not expected to mount an adequate immune response to the COVID-19 vaccines. This webpage will help assist you in understanding which treatments might be beneficial for your patients.

On this page:

What's new

Here are the most recent updates to this page:

Therapeutics decision resources

Overview of outpatient therapeutics

The chart below provides an overview of eligibility criteria, routes of administration, and links to fact sheets for each drug. For more detail, please refer to the HHS side-by-side comparison of outpatient treatments for mild-moderate COVID-19 (PDF).

  Paxlovid (Pfizer) Remdesivir (Gilead) Molnupiravir (Merck) Bebtelovimab
(Eli Lilly)
Age eligibility

12+

All

18+

12+
Initiate within # days of symptom onset

< 5 days

< 7 days

< 5 days

< 7 days
Mechanism of action

Viral protease inhibitor that halts viral replication.

Nucleoside analog that halts viral replication

Nucleoside analog that inhibits viral replication by viral mutagenesis

Monoclonal antibody against spike protein; blocks viral entry.
Route of administration

Oral

IV

Oral

IV
Duration of treatment

5 days

3 infusions over 3 days

5 days

One IV injection
Clinical considerations (May want to note on prescription order as applicable)
DHSS COVID-19 Oral Medication Order Form Aid (Word doc)

High efficacy,
ritonavir-related drug-drug interactions. Assess eGFR: dose adjustment for ≥30 to <60 mL/min, contraindicated for <30 mL/min.

High efficacy. FDA-approved. Determine eGFR, hepatic testing, and prothrombin time before therapy and during use as appropriate. Contraindicated for eGFR <30 mL/min.

Lower efficacy. Not recommended for use in pregnancy, counsel on use of contraception

Symptomatic improvement on Day 5 reduction in viral load vs. placebo. No direct comparison to other agents in trials.
Links Paxlovid: EUA fact sheet
for healthcare providers
, Paxlovid product website
Remdesivir:
Prescribing information (PDF)
, Remdesivir (VEKLURY) product website
Molnupiravir: EUA
fact sheet for healthcare providers
, Molnupiravir product website
Bebtelovimab: EUA fact sheet for healthcare providers, Bebtelovimab product website

Note:

Paxlovid rebound: In a study of 483 high-risk patients treated with Paxlovid, 4 patients experienced a rebound, which was generally mild, at median of 9 days after treatment, and all resolved without additional COVID-19-directed therapy. The CDC advises that there is currently no evidence that additional treatment is needed for COVID-19 rebound.

The FDA has updated its authorizations for the following monoclonal antibody treatments: GlaxoSmithKline's sotrovimab; Lilly's bamlanivimab plus etesevimab; Regeneron's casirivimab plus imdevimab (REGEN-COV). FDA says these treatments are not currently authorized due to their inactivity against Omicron subvariants

Pre-Exposure Prophylaxis

Evusheld (tixagevimab/cilgavimab) is a long-acting monoclonal antibody therapy that has been authorized by the FDA under EUA for pre-exposure prophylaxis for COVID-19. It is only authorized for individuals (aged ≥12 years and weighing ≥88 lbs) who are not currently infected with or recently exposed to COVID-19, and only for individuals who are moderately to severely immunocompromised or cannot be fully vaccinated with any available COVID-19 vaccines.

Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

This product is given by intramuscular injection every six months and may help prevent infection. For more information, read the NIH COVID-19 Treatment Guidelines Panel's statement on Evusheld.

In Alaska, Evusheld is available through nearly all infusions centers and clinics that care for the eligible patient populations.

Notes:

  • On June 29, 2022, FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection.
  • On February 24, 2022, the FDA increased the initial authorized dose of Evusheld to one injection of 300 mg of tixagevimab and 300 mg of cilgavimab. Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible to raise their monoclonal antibody levels to those expected for patients receiving the higher dose.

Distribution of therapeutics

Healthcare providers can find information about local availability of oral antiviral medications on the therapeutics locator map and therapeutics location data provided by the U.S. Department of Health and Human Services (HHS).

Information about monoclonal antibody infusion sites can be found on the HHS monoclonal antibody locator map as well as the National Infusion Center Association map.

Other resources

Webinars