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.
- Oral Antiviral Therapeutics
- IV Antiviral Therapeutics
- Monoclonal Antibody Therapeutics
- COVID-19 Test to Treat Federal Program
- Locator Sites
- Information for Providers
- Information for Patients
- How to Protect Yourself and Others
- Health Partner Ordering Platform (HPOP)
- Contact Information
The oral antiviral treatments, Molnupiravir (LAGEVRIO) and PAXLOVID, are treatments covered by an Emergency Use Authorization (EUA) and should be considered for patients who meet the criteria in each EUA.
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
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)
Veklury (remdesivir) is an antiviral drug that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults and pediatric patients with a positive SARS-CoV-2 test. Veklury is for people with mild to moderate COVID-19 symptoms and are at high risk for progression to severe COVID-19, including hospitalization or death.
Veklury is administered as an IV infusion over the course of 3 days and should be initiated within 7 days of symptom onset. It is commercially available to providers through Gilead Pharmaceuticals. Ask your healthcare provider if you are eligible for this medication.
- Link to ASPR webpage on Veklury Veklury (remdesivir) | HHS/ASPR
- Information for Healthcare Providers: Prescribing, Preparation, and Storage Information
Evusheld (Tixagevimab/cilgavimab) is a combination of two monoclonal antibodies to help prevent COVID-19 before exposure in those who have a moderately to severely compromised immune system, it is not used to treat to COVID-19 symptoms. This monoclonal antibody treatment is covered by an Emergency Use Authorization. Ask your healthcare provider if you are eligible for medication to prevent COVID-19 before exposure.
On 1/6/23 FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld
- Evusheld (Tixagevimab/Cilgavimab) EUA Letter of Authorization (Updated)
- Fact Sheet for Patients, Parents and Caregivers - EUA of EVUSHELD
- Fact Sheet for Health Care Providers - EUA of EVUSHELD
Previously Available Products
Throughout the pandemic, the federal government has granted Emergency Use Authorization (EUA) for therapeutics to help combat COVID-19. Some treatments have been paused or discontinued in favor of options that treat people infected with current strains of COVID-19 more effectively. Previously authorized therapeutic products may prove to be effective in treating future COVID-19 variants. Therefore, the HHS recommends that sites retain any stockpiles of paused or discontinued products. Additional information can be found at COVID-19 Paused and Discontinued Products | HHS/ASPR
On November 30, 2022, the U.S. Food and Drug Administration announced that bebtelovimab is no longer authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.
Bamlanivimab/estesevimab and REGEN- COV
As of January 24th, 2022, the FDA revised the EUA fact sheet for bamlanivimab/etesevimab and REGEN-COV noting these two COVID-19 treatment are no longer authorized for use. For more information, please read the full FDA annoucement.
As of April 5, 2022, the FDA updated the EUA fact sheet for Sotrovimab noting it 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 that are expected to retain activity against new variants. Available treatment options include: Paxlovid, Veklury, and Lagevrio.
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), Urgent Care Clinics, 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 and 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.
Ordering and Distribution Process for Monoclonal Antibodies and Antivirals
In early 2022, when demand for COVID therapeutics was very high and supplies were in very limited, the federal government partnered with states to ensure an equitable distribution to points of care utilized my those most at risk for severe disease. At the time of this update, there are no supply constraints on Paxlovid, Lagevrio, and Evusheld.
The federal government has also partnered with national and independent pharmacy networks to increase access and equity nationwide. The Federal Retail Pharmacy Therapeutics Program (FRPTP) partners receive a distribution directly from the federal government. Information and a list of FRPTP partners can be found at this link: FRPTP Fact Sheet | HHS/ASPR
As the supply of COVID Therapeutics is no longer constrained many of Connecticut HPOP enrolled providers have transitioned back to their commercial distributors. A limited number of HPOP enrolled providers are supported through DPH’s weekly allocation, these include hospitals, independent pharmacies, long term care pharmacies, and urgent cares. Enrolled providers can place orders that are reviewed and approved on a weekly basis and are required to report utilization and quantity on hand in HPOP every Monday and Thursday. For any questions, providers should email DPH at COVIDmeds.DPH@ct.gov.
There are steps you can take to protect yourself, your household, and your community from severe illness from COVID-19. These include staying up to date on vaccination, getting tested for COVID-19 if you are symptomatic, and seeking treatment if you test positive.
CDC recommends individuals put together a COVID-19 plan so you have all the information you need on hand if you get sick with COVID-19. Here is a link to the CDC COVID-19 Plan that can be downloaded, printed, and shared with your family, friends, and healthcare provider.
LINK to COVID-19 PLAN: COVID-19 Personal Plan (cdc.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 (December, 2022)
- Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities - PubMed (nih.gov)
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
- HPOP Provider User Guide (PDF)
- Example on How to Report Doses Available/Administered in HPOP
- Process for Ordering COVID-19 Therapeutics