Overview of COVID-19 Therapeutics and Prophylaxis for Non-Hospitalized Patients

The resources below provide:
  1. Interim guidance on outpatient treatment decisions for patients at risk of developing severe COVID-19.
  2. Comparison table of treatment options.

Treatment

*Adapted from COCA call 1/22/22
Clinicians should refer to the EUA healthcare provider fact sheets for further details on paxlovid, remdesivir, and molnupiravir. For the FDA-approved remdesivir (Veklury) for 12 yrs and older weight at least 40kg, refer to the full prescribing information.

Prophylaxis

There are currently no authorized prophylactic treatments for COVID-19.
Evusheld
Description
  • Evusheld is a monoclonal antibody combination approved for use as a Pre-exposure Prophylaxis for those who are unable to receive or are not expected to mount an immune response with vaccines.
  • Distribution should be prioritized to hospitals that offer special services such as oncology and rheumatology, etc. Providers who care for such patients should refer to these centers for access to this product.
Patient Profiles
  • Active treatment for solid tumor and hematologic malignancies
  • Receipt of solid-organ transplant and taking immunosuppressive therapy
  • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within two years of transplantation or taking immunosuppression therapy)
  • Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
  • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents).

Locate COVID-19 Therapeutics In The City

Patients and health care providers may use the ASPR Treatments Locator to search for sites with commercial COVID-19 therapeutics inventory. Locations participating in the Paxlovid USG Patient Assistance Program (PAP) are also included on the locator. Find pharmacies, clinics, and other locations with safe and effective low cost COVID-19 medications.

State and Federal Reporting Requirements

  • Providers are expected to report all USG courses that they received and should report inventory, administration/dispensing, and disposal data until the provider’s USG product inventory is fully reconciled. 
    • Note: As of March 8, 2024, EUA-labeled Paxlovid is no longer authorized for use. All remaining EUA-labeled Paxlovid, regardless of expiration date, must be disposed of on site in accordance with all federal, state, and local regulations or returned for disposal. 
  • The U.S. Government has developed a mechanism for providers to report commercial treatment location data voluntarily that is now visible in an expanded treatments locator tool.
  • Sites can voluntarily upload commercially acquired inventory data for Paxlovid, Lagevrio, and outpatient Veklury via HPOP. HPOP users can leverage their existing accounts to note product availability, while non-HPOP users can use the HPOP volunteer reporting website
    • Sites only need to note that the product is available – not the number of treatment courses – once every 60 days, although more frequent updates provide more accurate information to patients and providers.

Provider Resource Library and Other Useful Links

Shelf life Extensions

Shelf-Life Extension infomation. Click the links to view the affected lot numbers.

New! Searchable database of COVID-19 Therapeutic Product Expiration Dates is now available
 
Access COVID-19 Antivirals for Free or at a Reduced Cost
On Nov. 1, 2023, Paxlovid and Lagevrio became commercially available. Patient assistance programs that help pay for these drugs are available to people who are underinsured, uninsured, or publicly insured through Medicaid, Medicare or other programs. See Sample Antiviral Access Programs