Case-Based Training Videos for Prescribers

Maine CDC, in collaboration with healthcare partners, has developed a series of recorded videos covering basic information about who to treat for COVID-19, available drugs, how to select the right drug for your patient, and how to access treatments in Maine, with several case-based examples of common clinical scenarios. These videos, aimed at healthcare providers who are not yet familiar with the outpatient treatment of COVID-19, are now available for free on YouTube, with accompanying slides.

COVID-19 Treatment in Maine: A Primer for Prescribers

• Videos
• Slides (PDF)

Overview of COVID-19 Vaccines and Therapeutics

COVID-19 vaccination remains the best way to prevent COVID-19 infection, hospitalization, and death. Vaccination is recommended for all persons age 6 months and older. Booster doses are recommended for persons age 5 years and older and are essential for preventing infection and severe disease as COVID-19 variants appear. People with immunocompromising conditions, including those who take certain immunosuppressive medications, are at increased risk for severe COVID-19 and should get additional pre-exposure prophylaxis after vaccination to further reduce the risk of infection and severe disease.

Infections, hospitalizations, and deaths continue to occur in unvaccinated individuals and in vaccinated individuals. Outpatient treatment can reduce the risk of progressing from mild illness to severe disease. Treatment is available for persons who have COVID-19 symptoms, a positive test (either PCR or antigen), and have one or more risk factors for severe COVID-19 (including age over 50 years, being unvaccinated or not being up to date on COVID-19 vaccinations, or specific medical conditions and behaviors).

Encourage patients at high risk for severe disease to test early and treat within the first few days after symptom onset, even if symptoms are mild. Many people with COVID-19 are at high risk for severe disease and can get treated, yet they do not learn about treatment options in time, or they encounter problems obtaining a prescription within the recommended timeframe. To aid in sharing information with patients about the availability of these medicines, we created simple graphics that you can print, post, and give to patients.

To find pharmacies in Maine that can fill a prescription for oral antivirals, and Test-to-Treat locations in Maine where patients can get tested, see a provider, and get treated, go to COVID-19 Treatment in Maine.

Summary of Vaccines and Therapeutics

All persons age 6 months and older	COVID-19 vaccines and boosters	U.S. CDC: Use of COVID-19 Vaccines in the United States Maine CDC: COVID-19 Vaccine Providers Portal
Persons age 6 months and older with moderate or severe immunocompromise	COVID-19 vaccines and boosters	U.S. CDC: COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised Maine CDC: COVID-19 Vaccine Providers Portal Maine CDC: COVID-19 Pre-Exposure Prophylaxis (Provider Information) Note: Long-acting antibodies for pre-exposure prophylaxis were previously available but are no longer authorized for use in the U.S. due to emerging variants. Simliar products that protect against the recent variants are under study and Maine CDC will share information if and when other products become available.
Persons exposed to COVID-19 who have not tested positive (i.e., post-exposure prophylaxis)	No treatments currently available	Note: monoclonal antibody therapies that were previously available for this purpose are no longer available due to poor effectiveness for current variants
Persons with asymptomatic COVID-19 infection	Symptomatic treatment only	Ensure readiness to test and access treatment if symptomatic and eligible. Monitor closely for the development of COVID-19 symptoms and treat if eligible.
Persons with mild or moderate COVID-19 symptoms and a positive test who are not at high risk for severe disease	Symptomatic treatment only
Persons with mild or moderate COVID-19 illness, a positive test (NAAT or antigen), and who have one or more risk factors for severe COVID-19 (including age over 50 years, being unvaccinated or not being up to date on COVID-19 vaccinations, or specific medical conditions and behaviors)	Oral antivirals IV antivirals	See additional treatment information below To find a pharmacy that can fill a prescription from any doctor, or a Test-to-Treat location where patients can get tested, seen by a provider, and treated, see COVID-19 Treatment in Maine (Patient Information). Note: monoclonal antibody therapies that were previously available for this purpose are no longer available due to poor effectiveness for current variants.
Persons with severe or critical COVID-19 symptoms	Advanced care	These persons should be seen urgently. Further treatment information is not covered here.

COVID-19 Treatment for Non-Hospitalized Patients

The U.S. Food and Drug Administration (FDA) has authorized or approved several COVID-19 therapies for certain patients. Several of these medications are available under FDA Emergency Use Authorization: note that eligibility is set by the FDA and off-label prescribing is not allowed for drugs available under EUA.

Medicine	Eligibility and notes	Resources
Paxlovid (nirmatrelvir/ritonavir) (PO) Oral therapy (5 days) Start within 0–5 days after COVID-19 symptoms begin Available under FDA Emergency Use Authorization	Individuals 12+ years old at high risk for progression to severe COVID-19 Treatment of choice for non-hospitalized patients (per NIH treatment guidelines (PDF)).	FDA: Paxlovid EUA Fact Sheet for Healthcare Providers (PDF) FDA: Paxlovid EUA Fact Sheet for Patients, Parents, and Caregivers (PDF) PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers FDA Updates on Paxlovid for Health Care Providers ASPR: COVID-19 Therapeutics Locator Maine CDC: Paxlovid prescription best practices
Veklury (remdesivir) (IV) IV therapy (daily x 3 days) Start within 0–7 days after COVID-19 symptoms begin FDA-approved	Individuals 28 days old and older at high risk for progression to severe COVID-19 Best option for patients who are unable to get Paxlovid due to drug-drug interaction. However, it requires insurance coverage and is not widely available at this time. Currently only available at selected facilities in Maine, primarily for patients under 12 years old. Consider for patients who are hospitalized for a non-COVID-19 cause if Paxlovid is not available in the inpatient setting or they lack oral access.	Gilead: PrescribingInformation for VEKLURY(for providers) Gilead: Important Facts about VEKLURY (for patients)  As of July 2022, Veklury for outpatients is available in Maine only at Maine Medical Center, LincolnHealth, and Eastern Maine Medical Center (see Where to Get Treated)
Lagevrio (molnupiravir) (PO) Oral therapy (5 days) Start within 0–5 days after COVID-19 symptoms begin Available under FDA Emergency Use Authorization	Individuals 18+ years old at high risk for progression to severe COVID-19 Best pick for patients who are unable to get Paxlovid due to drug-drug interaction or severe kidney or liver disease, and who do NOT have access to an IV infusion site (for remdesivir or Veklury). This medication has lower effectiveness than the other three therapies.	FDA: Lagevrio (molnupiravir) EUA Fact Sheet for Healthcare Providers (PDF) FDA: Lagevrio (molnupiravir) EUA Fact Sheet for Patients, Parents, and Caregivers (PDF) ASPR: COVID-19 Therapeutics Locator

Paxlovid prescription best practices

Prescribers writing prescriptions for Paxlovid should include the dispense-by date (i.e., within 5 days of the symptom onset date) and are encouraged to include information about the patient’s renal function and a statement that the patient’s medication list has been reviewed/reconciled. For further information, refer to FDA’s PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers (PDF).

Essential elements of a Paxlovid prescription

• Numeric dose of each active ingredient within PAXLOVID
• Dispense-by date (i.e., within 5 days of symptom onset)
• Optional: Renal function
• Optional: Medication list reviewed/reconciled

Patients at High, Higher, and Highest Risk for Severe Disease

Healthcare providers should offer treatment to older adults and others at high risk for progression to severe disease. Treatment of mild/moderate COVID-19 is the standard of care for eligible patients. The following information, based on analysis of Maine’s COVID-19 cases, hospitalizations, and deaths in early 2022 (the Omicron wave), describes patients at high, higher, and highest risk for severe disease. All of these patients are eligible to receive treatment if they have COVID-19 symptoms and a positive COVID-19 antigen or PCR test. This information may be helpful in guiding patient counseling prior to illness onset.

Category	Groups	Action
High Risk for Severe Disease	Persons age 50 years and older Unvaccinated persons People with underlying conditions1 placing them at higher risk for severe COVID-19	If COVID-19 symptoms and positive test, offer outpatient treatment
Higher Risk for Severe Disease	Unvaccinated2, 65+ years Vaccinated2, 65+ years, with 1+ risk factors1 Unvaccinated2 or vaccinated2, with 2+ risk factors1 Residing in a congregate facility3	If COVID-19 symptoms and positive test, offer outpatient treatment
Highest Risk for Severe Disease	Moderately/Severely Immunocompromised4 Unvaccinated1 or Vaccinated1, 75+ years Unvaccinated1, 50+ years, with 1+ risk factors2 Unvaccinated1, Pregnant5	If COVID-19 symptoms and positive test, offer outpatient treatment

• ¹ Some of the most important Underlying Medical Conditions Associated with High Risk for Severe COVID-19 include cancer, cardiovascular disease, chronic kidney disease, chronic lung disease, diabetes, immunocompromising conditions or receipt or immunosuppressive medications, obesity (BMI ≥30), pregnancy, sickle cell disease.
• ² Unvaccinated refers to someone who has not received 2 doses of an mRNA vaccine or 1 dose of the J&J vaccine. Vaccinated refers to someone who received 2 doses of an mRNA vaccine or 1 dose of the J&J vaccine. Vaccinated individuals who have not received a vaccine booster dose are likely at higher risk for severe disease than those who are boosted.
• ³ Persons living in nursing homes, assisted living facilities, jails, prisons, and homeless shelters who do not meet higher-level criteria.
• ⁴ Moderately or Severely Immunocompromised People include people who have been receiving active cancer treatment for tumors or cancers of the blood, received an organ transplant and are taking medicine to suppress the immune system, received a stem cell transplant within the last 2 years or taking medicine to suppress the immune system, moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome), advanced or untreated HIV infection, or active treatment with high-dose corticosteroids or other drugs that suppress the immune response.
• ⁵ COVID-19 patients who are pregnant, or were recently pregnant, are more likely to get very sick from COVID-19 compared to people who are not pregnant.

Locations in Maine that Test, Assess, Dispense, and Treat

To access treatment in Maine, see COVID Treatment in Maine for information on

• pharmacies where patients can fill prescriptions for oral drugs and
• Test-to-Treat sites (e.g., hospitals, clinics, urgent care centers, and pharmacies) where patients can get tested, seen by a clinician, and treated with oral and IV drugs.

Some locations offer telemedicine and/or home delivery services.

Clinical Resources for COVID-19 Treatment

U.S. CDC has provided Interim Clinical Considerations for COVID-19 Treatment in Outpatients to help clinicians determine  who is considered at high risk for severe disease, for the purposes of treatment. In particular, U.S. CDC highlighted several key risk factors for severe COVID-19:

• Age over 50 years, with risk increasing substantially at age ≥ 65 years
• Being unvaccinated or not being up to date on COVID-19 vaccinations
• Specific medical conditions and behaviors

Some people from racial and ethnic minority groups are at risk of being disproportionately affected by COVID-19 from many factors, including limited access to vaccines and healthcare. Healthcare providers can consider these factors when evaluating the risk for severe COVID-19 and use of outpatient therapeutics.

NIH COVID-19 treatment guidelines provide the key recommendations regarding treatment options, including the Therapeutic Management of Nonhospitalized Adults With COVID-19.

NIH: Therapeutic Management of Nonhospitalized Adults with Mild to Moderate COVID-19 Who Do Not Require Supplemental Oxygen

Last Updated: December 28, 2022

Patient Disposition	Panel's Recommendations
All Patients	All patients should be offered symptom management (AIII). The panel recommends against the use of dexamethasonea or other systemic corticosteroids in the absence of another indication (AIIb).
Patients Who Are at High Risk of Progressing to Severe COVID-19b	Preferred therapies. Listed in order of preference: Rotinavir-boosted nirmatrelvir (Paxlovid)c,d (AIIa) Remdesivird,e (BIIa) Alternative therapy. For use when the preferred therapies are not available, feasible to use, or clinically appropriate: Molnupiravird,f,g (CIIa)
Each recommendation in the Guidelines receives 2 ratings that reflect the strength of the recommendation and the quality of the evidence that supports it. See Guidelines Development for more information.
a There is currently a lack of safety and efficacy data on the use of dexamethasone in outpatients with COVID-19. Using systemic glucocorticoids in outpatients with COVID-19 may cause harm. b For a list of risk factors, see the CDC webpage Underlying Medical Conditions Associated With Higher Risk for Severe COVID-19. When deciding whether to prescribe antiviral treatment to a patient who has been vaccinated, clinicians should be aware of the conditions associated with a high risk of disease progression. These conditions include older age, a prolonged amount of time since the most recent vaccine dose (e.g., >6 months), and a decreased likelihood of an adequate immune response to vaccination due to a moderate to severe immunocompromising condition or the receipt of immunosuppressive medications. The number and severity of risk factors also affects the level of risk. cRitonavir-boosted nirmatrelvir has significant drug-drug interactions. Clinicians should carefully review a patient’s concomitant medications and evaluate potential drug-drug interactions. See Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications for more information. d If a patient requires hospitalization after starting treatment, the full treatment course can be completed at the health care provider’s discretion. eAdministration of remdesivir requires an IV infusion once daily for 3 days. fMolnupiravir appears to have lower efficacy than the other options recommended by the Panel. Therefore, it should be considered when the other options are not available, feasible to use, or clinically appropriate. gThe Panel recommends against the use of molnupiravir for the treatment of COVID-19 in pregnant patients unless there are no other options and therapy is clearly indicated (AIII). Key: CDC = Centers for Disease Control and Prevention; IV = intravenous; the Panel = the COVID-19 Treatment Guidelines Panel

HHS/ASPR has developed the following clinical decision aid (PDF) for selecting from available treatment options.