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Therapeutic Options for COVID-19 Patients
Information about investigational medication treatments (therapeutics), to be updated as new information is available.
Quick reference tools for providers
- Clinical Considerations for Prescribing Oral Antivirals
Checklist of eligibility criteria to consider prior to prescribing molnupiravir (Lageviro) or nirmatrelvir/ritonavir (Paxlovid) in adult or pediatric patients. - U.S. Department of Health and Human Services (HHS): Clinical Decision Aid for Outpatient Therapeutics (PDF)
Decision tree for high-risk adult and pediatric patients to determine outpatient treatment for mild to moderate COVID-19. - Clinical Recommendations for Patients with Underlying Medical Conditions: COVID-19
Includes CDC recommendations on underlying medical conditions associated with risk for severe COVID-19 that may benefit from antiviral treatment. - HHS/Administration for Strategic Preparedness and Response (ASPR) Covid-19 Medications Locator
National map displaying pharmacies, clinics and other locations with COVID-19 medications. Test-to-Treat sites and locations participating in the U.S. Government Patient Assistance Program for Paxlovid are included. - University of Liverpool COVID-19 Drug Interactions
Interactive website to check drug interactions with COVID-19 medications, including Paxlovid. - Pfizer: Paxlovid Access-Support
Educational materials for patients and providers (brochures, one-pagers, flash cards) available for download.
Oral antivirals
Nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio) are authorized for the treatment of mild to moderate COVID-19 in patients at increased risk for severe illness. Paxlovid is the preferred first line therapy and is FDA-approved for use in adults, but remains under emergency use authorization for children 12-17 years of age. Molnupiravir is authorized for use in adults 18 years and older for whom other therapies are not available or clinically appropriate. Patients are not required to have a positive test to be treated with oral antivirals but should have a current clinical diagnosis of mild to moderate COVID-19.
- Currently the preferred first-line therapy for treatment of eligible patients with COVID-19. Refer to NIH: COVID-19 Treatment Guidelines: Therapeutic Management of Nonhospitalized Adults with COVID-19.
- Combination of a SARS-CoV-2 protease inhibitor (nirmatrelvir) with ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor. Ritonavir acts as a pharmacological booster to increase the levels of nirmatrelvir.
- Authorized for the treatment of mild-to-moderate COVID-19 in patients at high risk for severe illness from COVID-19.
- For information on medical conditions and factors associated with increased risk, visit CDC: Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19. This list is not exhaustive and providers should consider the risks and benefits for individual patients.
- Treatment must be started within five days of symptom onset and is given as a five-day treatment course.
- Efficacy: In the EPIC-HR trial (Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults, New England Journal of Medicine), ritonavir-boosted nirmatrelvir (Paxlovid) reduced the risk of hospitalization or death by 89% compared to placebo in non-hospitalized, high-risk, unvaccinated adults with laboratory-confirmed SARS-CoV-2 infection.
The following are limitations to the use of Paxlovid:
- Paxlovid is not authorized for use in patients younger than 12 years.
- Paxlovid is not recommended for use in patients with severe renal impairment (GFR<30ml/min) or hepatic impairment (Child-Pugh Class C).
- For patients with moderate renal impairment (GFR 30-60ml/min), the dose of nirmatrelvir should be reduced from 300mg to 150mg (refer to FDA: Fact Sheet for Providers below).
Due to the co-administration with ritonavir, it is critical to evaluate the patient medication regimen for potentially serious drug-drug interactions prior to prescribing Paxlovid.
- Providers should review the patient’s medication regimen (including over-the-counter medications, supplements, and any recreational drugs) for potentially serious drug interactions.
- Interactions may be checked using the University of Liverpool COVID-19 Drug Interactions interactive webpage.
COVID-19 rebound:
- Rebound is defined as experiencing recurrence of symptoms and/or SARS-CoV-2 test positivity after initial resolution.
- Rebound has been observed in patients receiving other antiviral treatment for COVID-19 besides Paxlovid as well as in patients receiving no treatment.
- Studies suggest patients with rebound typically have mild symptoms and have an extremely low probability of developing severe COVID-19.
- Paxlovid continues to be recommended for early-stage treatment of COVID-19 in patients at high risk for severe disease and should not be withheld solely due to concerns about rebound.
- Patients should be counseled to follow isolation guidance if they develop rebound. More information for providers is available at CDC Health Alert Network: COVID-19 Rebound After Paxlovid Treatment.
References:
- Currently recommended as an alternative therapy for use when the preferred therapies (Paxlovid or outpatient remdesivir, see below) are not available, feasible to use, or clinically appropriate. See NIH COVID-19 Treatment Guidelines: Therapeutic Management of Nonhospitalized Adults with COVID-19.
- Oral nucleoside analogue that inhibits SARS-CoV-2 replication by inducing viral mutagenesis.
- Authorized for the treatment of mild to moderate COVID-19 in patients at high risk for severe illness from COVID-19.
- For information on medical conditions and factors associated with increased risk, see CDC: Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19. This list is not exhaustive and providers should consider the risks and benefits for individual patients.
- Treatment must be started within five days of symptom onset and is given as a five-day treatment course.
- Efficacy: In the MOVe-OUT trial (Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients, New England Journal of Medicine) molnupiravir reduced the rate of hospitalization or death by 30% compared to placebo in non-hospitalized, unvaccinated, high-risk adults with laboratory-confirmed SARS-CoV-2 infection.
The following are limitations to the use of molnupiravir.
- Molnupiravir is not authorized for use in patients younger than 18 years.
- Molnupiravir is not recommended for use in pregnancy. Patients of childbearing potential should be advised to use effective contraception correctly and consistently, as applicable, for the duration of treatment and for four days after the last dose of molnupiravir.
- Molnupiravir is not recommended for use while breastfeeding. Breastfeeding is not recommended during treatment and for four days after the last dose of molnupiravir. A lactating individual may consider interrupting breastfeeding and may consider pumping and discarding breast milk during treatment and for four days after the last dose of molnupiravir.
References:
Patient Assistance Programs for Oral Antivirals
Oral antivirals are now commercially distributed and patients may face co-pays for their prescription. Providers are encouraged to assist patients with enrollment in a patient assistance program at the time of prescribing to obtain free medication or cover some or all of their out-of-pocket costs.
Paxlovid
Patient insurance status: Patients on Medicare, Medicaid, other state/federal insurance program such as CHIP, Tricare, VA, or uninsured.
Pfizer U.S. Government Patient Assistance Program (USG PAP)
PAXCESS Patient Support Program
Tel: 877-219-7225 (877-C19-PACK) (toll-free)
Eligible patients receive voucher to exchange for Paxlovid treatment course at participating pharmacies at no cost to the patient.
Patient Insurance Status: Commercial (private) insurance
Pfizer Co-Pay Savings Program
Paxlovid PAXCESS Patient Support Program OR Paxlovid: Enroll in the Co-Pay Savings Program
Eligible patients receive a co-pay card to cover up to $1500 per prescription or the amount of their co-pay, whichever is less.
Lagevrio
Patient insurance status: Patients who are uninsured or whose insurance does not cover Lagevrio.
Merck Patient Assistance Program
MerckHelps: LAGEVRIO
Tel: 800-727-5400 (toll-free)
Eligible patients will receive Lagevrio free of charge.
Visit: Commercial Availability of Oral Antiviral Medication for COVID-19 for more detailed information on these patient assistance programs.
Remdesivir
Remdesivir is approved by the FDA under the name Veklury for the treatment of COVID-19 in adult and pediatric patients (ages 28 days and older and weighing at least 3 kg) who are either hospitalized or who are not hospitalized but have mild to moderate COVID-19 and are at high risk for progression to severe illness. Remdesivir is available commercially and is not being distributed by the federal government.
- Currently recommended as a preferred therapy for use in eligible patients if Paxlovid is not clinically appropriate (e.g., due to significant drug-drug interactions). See NIH COVID-19 Treatment Guidelines: Therapeutic Management of Nonhospitalized Adults with COVID-19.
- Inhibitor of SARS-CoV-2 RNA-dependent RNA polymerase which interrupts viral replication.
- Previously approved only in hospitalized patients but expanded approval to outpatient use in January 2022.
- In the PINETREE trial (Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients, New England Journal of Medicine), three consecutive days of IV remdesivir resulted in an 87% reduction in the risk of hospitalization or death compared to placebo in non-hospitalized, high-risk, unvaccinated patients with laboratory-confirmed SARS-CoV-2 infection.
- Treatment should be initiated as soon as possible and within seven days of symptom onset.
Availability:
- Due to logistical constraints on administration, outpatient remdesivir is not widely available.
- Locations offering outpatient remdesivir have been added to the HHS/ASPR Covid-19 Therapeutics Locator; however, since remdesivir is not being distributed by the federal government, facilities must opt in to appearing on the locator and thus this list may not be comprehensive.
- Providers should check with their nearest hospital or infusion center to see whether outpatient remdesivir treatment can be arranged. Infectious disease consultation may be required.
References:
Monoclonal antibody (mAb) treatment
Update 1/27/23: Due to lack of effectiveness against currently circulating variants of SARS-CoV-2, there are currently no monoclonal antibodies authorized for use for the treatment or prevention of COVID-19 in the U.S.
Other treatments
COVID-19 convalescent plasma (CCP) is human plasma obtained from donors who have recovered from COVID-19. It may contain antibodies to SARS-CoV-2 that suppress viral replication. As of Dec. 28, 2021, CCP with high titers of anti-SARS-CoV-2 antibodies is currently authorized for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment. It is authorized for use in either the outpatient or the inpatient setting. This authorization is based on the totality of the scientific evidence available that suggests the potential benefits of CCP outweigh the potential risks when used for this indication. However, additional data from randomized controlled clinical trials are needed.
Plasma donations must be tested by registered or licensed blood establishments for high titers of anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release, using one of the tests and qualifying results listed in the FDA EUA.
Clinical dosing may first consider starting with one high titer CCP unit (about 200mL), with administration of additional high titer CCP units based on the prescribing physician’s judgment and the patient's clinical response.
Tocilizumab is an interleukin (IL)-6 inhibitor that can be used in hospitalized patients with progressive severe or critical COVID-19 illness that demonstrate elevated markers of inflammation. For a more complete review of the evidence, benefits/harms and treatment criteria, refer to the National Institutes of Health (NIH) and Infectious Disease Society of America (IDSA) COVID-19 treatment guidelines below:
- IDSA Guidelines on the Treatment and Management of Patients with COVID-19
Last updated March 1, 2023 - NIH COVID-19 Treatment Guidelines: Interleukin-6 Inhibitors
Last updated Jan. 26, 2023
Baricitinib is a Janus kinase (JAK) inhibitor that can be used in hospitalized patients with severe COVID-19 disease and elevated inflammatory markers, but not requiring mechanical ventilation. It can also be given in conjunction with remdesivir to hospitalized patients with severe disease who are unable to receive corticosteroids due to a contraindication. For a more complete review of the evidence, benefits/harms and treatment criteria, refer to the NIH and IDSA COVID-19 treatment guidelines below:
- IDSA Guidelines on the Treatment and Management of Patients with COVID-19
Last updated March 1, 2023 - NIH COVID-19 Treatment Guidelines: Kinase Inhibitors: Janus Kinase Inhibitors, and Bruton's Tyrosine Kinase Inhibitors
Last updated Aug. 8, 2022
Educational resources for providers
- IDSA: Management of Drug Interactions with Paxlovid (PDF)
Resource for clinicians with information on the management of the most commonly prescribed drug interactions with Paxlovid. - HHS/ASPR COVID-19 Therapeutics: Resources for Healthcare Professionals and Public Health Officials
Therapeutics clinical implementation guide, side-by-side overview of current outpatient therapies, FAQs on therapeutics, shelf life extensions, FDA announcements and updates on federal COVID-19 medical countermeasures
Other COVID-19 response guidance
For other health care related COVID-19 response guidance documents, including ethical frameworks for allocation of ventilators and cardiopulmonary resuscitation as well as previous operational guidance for therapeutics, please visit Crisis Standards of Care.
Thank you for your continued partnership. For health care questions, please contact the MDH provider hotline at 651-201-5414.