The U.S. Food and Drug Administration (FDA) authorized emergency use of three monoclonal antibody therapeutics and two oral antiviral therapeutics for the treatment of patients with COVID-19. These treatments have been shown to reduce hospitalization and deaths in high risk COVID-19 patients with mild to moderate symptoms. The FDA also has authorized emergency use of one long-acting antibody combination for prevention of COVID-19 in some patients.
Molnupiravir (LAGEVRIO), Paxlovid, Evusheld, and Bebtelovimab are among the new therapeutics. These therapeutics differ in efficacy, route of administration, risk profile, and populations for which they are authorized. Some also have important contraindications and drug-drug interactions. For more information please visit the HHS Side-by-Side Overview of Outpatient Therapies Authorized for Treatment of Mild-Moderate COVID-19.
This webpage is updated with the latest therapeutic information on a regular basis. Make sure to check back for important information including EUA updates, reporting platform changes, or other related topics.
- COVID-19 Test to Treat Federal Program
- Locator Sites
- Monoclonal Antibody Therapeutics
- Oral Antiviral Therapeutics
- Information for Providers
- Information for Patients
- Health Partner Ordering Platform (HPOP)
- Contact Information
COVID-19 Test to Treat Federal Program
Test to Treat is a new nationwide initiative that will give individuals an important new way to rapidly access free lifesaving treatment for COVID-19. In this program, people will be able to get tested and – if they are positive and treatments are appropriate for them – receive a prescription from a health care provider, and have their prescription filled all in one location. These “One-Stop Test to Treat” locations will be available at hundreds of locations nationwide, including pharmacy-based clinics, federally-qualified community health centers (FQHCs), and long-term care facilities. People will also continue to be able to be tested and treated by their own health care providers who can appropriately prescribe these oral antivirals at locations where they are being distributed.
- ASPR Fact Sheet: COVID-19 Test to Treat
- ASPR Test to Treat
- ASPR Test to Treat Locator
- How Test to Treat Sites Work (NBC Connecticut)
The U.S. Department of Health and Human Services (HHS) and the National Infusion Center Association (NICA) have provided the locations that have received shipments of COVID 19 therapeutics under the emergency use authorization (EUA) through their respective locators. The HHS COVID-19 Therapeutics Locator is continually adding locations and the map does not include all the sites with COVID-19 Therapeutics. Healthcare providers may wish to contact these locations to arrange for a patient to receive monoclonal antibody treatment. If you are a provider with questions on where to go for COVID-19 Therapeutics please send an email to DPHCovid.firstname.lastname@example.org and we will connect you with a location that is offering them. Patients should coordinate with their respective physician or care provider before contacting a location to receive treatment.
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. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval.FDA continues to monitor the neutralizing activity of Evusheld against emerging SARS-CoV-2 variants and will provide additional updates as needed. For further details, please refer to the FDA’s Frequently Asked Questions for Evusheld.
June 28, 2022 - FDA authorized the shelf-life extension of Evusheld from 18 months to 24 months for specific lots of refrigerated Evusheld. Please visit the ASPR website to learn more about this authorization, view an updated table of the effected co-pack lot numbers, labelled co-pack expiration dates, and extended co-pack expiration dates.
Tixagevimab/cilgavimab (EVUSHELD), a long-acting monoclonal antibody combination, is authorized for the pre-exposure prophylaxis (prevention) of COVID-19 in eligible adults and children 12 and older. This product is only authorized for people who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual with COVID-19. The authorization requires that patients either have moderate to severely compromised immune systems that may not mount an adequate immune response to COVID-19 vaccination, or a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines.
- Tixagevimab/Cilgavimab EUA Letter of Authorization (Updated)
- Tixagevimab/Cilgavimab – Storage and Stability (AstraZeneca)
- Tixagevimab/Cilgavimab – General Ingredients (AstraZeneca)
- Tixagevimab/Cilgavimab – Clinical Development Overview (AstraZeneca)
- Fact Sheet for Patients, Parents and Caregivers - EUA of EVUSHELD
- Fact Sheet for Health Care Providers - EUA of EVUSHELD
Eli Lilly’s bebtelovimab is a monoclonal antibody for the treatment of mild to moderate COVID-19 in adults and certain pediatric patients who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate. Bebtelovimab is administered as an intravenous injection.
- Bebtelovimab EUA Letter of Authorization
- Fact Sheet for Health Care Providers – EUA of Bebtelovimab
- Fact Sheet for Patients, Parents and Caregivers – EUA of Bebtelovimab
Other Monoclonal Antibody Therapeutics
As of January 24th, 2022, Because data show bamlanivimab/etesevimab and REGEN-COV are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions. For more information, please read the full FDA annoucement.
As of April 5, 2022, Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients. FDA will continue to monitor BA.2 in all U.S. regions and will provide follow-up communication when appropriate. (CDC Press Release)
Molnipiravir (LAGEVRIO) is for treating adults age 18 years and older, who are at high risk for progressing to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate.
- Molnupiravir EUA Letter of Authorization
- Fact Sheet for Health Care Providers - EUA of Molnupiravir
- Fact Sheet for Patients and Caregivers – EUA of Molupiravir
- Frequently Asked Questions on EUA for Molnupiravir
- DPH Molnupiravir Briefing Sheet
- Molnupiravir Quick Point-of-Care Reference (IDSA)
Paxlovid is authorized for treatment of mild to moderate COVID-19 in adults and pediatric patients age 12 years and older weighing at least 40 kg, with a positive SARS-CoV-2 test, who are at high risk for progressing to severe COVID-19, including hospitalization or death. Renal Paxlovid is a different dosing regimen of Paxlovid that is used for patients who have moderately impaired renal function.
- Paxlovid EAU Letter of Authorization
- Fact Sheet for Health Care Providers – EUA of Paxlovid (Updated)
- Fact Sheet for Patients, Parents, and Caregivers – EUA of Paxlovid
- Emergency Use Full Prescribing Information – Health Care Provider Fact Sheet (Pfizer)
- Paxlovid Point-of-Care Reference (IDSA)
- PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers (fda.gov)
- FDA Updates on Paxlovid for Health Care Providers | FDA
- Management of Drug Interactions With Nirmatrelvir/Ritonavir (Paxlovid®): Resource for Clinicians (idsociety.org)
- New Paxlovid Dose Pack Authorized by FDA
Ordering and Distribution Process for Monoclonal Antibodies and Antivirals
NIH has established guidelines to prioritize anti-SARS-CoV-2 therapies while they are in short supply. The Department of Public Health (DPH) works with healthcare partners to target the most at-risk patients while allocations from the federal government are limited.
For distribution of therapeutics, DPH is notified of Connecticut’s allocation of antivirals and monoclonal antibodies and then works with its partners to determine distributions within Connecticut. As of now, partners cannot order therapeutics directly through the new reporting and allocation system, Health Partner Ordering Platform (HPOP), but will receive allocations from DPH. Partners are required to report daily utilization and quantity on hand in HPOP to continue receiving allocations. For any questions, providers should email DPH at COVIDmeds.DPH@ct.gov.
Connecticut Department of Public Health
- HHS Therapeutics Decision Aid
- Using Therapeutics to Prevent and Treat COVID-19 (CDC HAN)
- HHS Monoclonal Antibody Therapeutics webpage
- HHS COVID-19 Treatments and Therapeutics webpage
- Side-by-Side Overview of Outpatient Therapies Authorized for Treatment of Mild-Moderate COVID-19
- Planning Considerations for Monoclonal Antibody Administration Tip Sheet
National Institutes of Health (NIH) Resources
- Updated COVID-19 Treatment Guidelines Panel’s Statement on the Prioritization of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment or Prevention of SARS-CoV-2 Infection When There Are Logistical or Supply Constraints (October 7, 2021)
- Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities - PubMed (nih.gov)
Infectious Diseases Society of America (IDSA) Resources
- CDC/IDSA COVID-19 Clinician Call: Outpatient COVID-19 Treatment Strategies for High-Risk Populations, Q&A (January 22, 2022)
- CDC/IDSA COVID-19 Clinician Call: Outpatient COVID-19 Treatment Strategies for High-Risk Populations, Recording (January 22, 2022)
- IDSA COVID-19 Outpatient Treatment Guidelines Roadmap
Connecticut Therapeutic News Spots
- How Test to Treat Sites Work (NBC Connecticut)
- Connecticut's public health commissioner reminds doctors about anti-coronavirus medicines (Connecticut Public Radio)
Center for Disease Control and Prevent
Department of Health and Human Services
Health Partner Ordering Platform
The Health Partner Ordering Platform (HPOP) is an ordering portal for allocating and/or requesting therapeutic products. HPOP will be used to order new products (AstraZeneca, Merck, Pfizer, etc).
HHS HPOP Help Desk Information for Users
- For any issues with logging into HPOP, please email email@example.com
- For password resets, please use the “I forgot my password” link on the sign-in screen
- For any issues with using the HPOP portal, please email HPOP-Therapeutics@hhs.gov
- For general program questions, please email COVID19Therapeutics@hhs.gov
HPOP Provider Resources