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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
- Infectious Diseases Society of America (IDSA): Guidelines on the Treatment and Management of Patients with COVID-19
Clinical practice guidelines on the treatment and management of hospitalized and non-hospitalized patients with COVID-19. - The American College of Obstetricians and Gynecologists: COVID-19 FAQs for Obstetrician-Gynecologists, Obstetrics
FAQs for clinicians on the management of COVID-19 in patients who are pregnant or lactating. - CDC: Underlying Conditions and the Higher Risk for Severe COVID-19
CDC recommendations on underlying medical conditions associated with risk for severe COVID-19 that may benefit from antiviral treatment. - Health & Human Services (HHS)/Administration for Strategic Preparedness & Response (ASPR): Covid-19 and Flu Treatments Locator
National map displaying pharmacies, clinics, and other locations with COVID-19 and influenza medications in stock. 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 and children aged older than 12 years. 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 IDSA: Nirmatrelvir/Ritonavir: Guidelines on the Treatment and Management of Patients 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 Conditions and the 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 hepatic impairment (Child-Pugh Class C).
- For patients with renal impairment (GFR <60ml/min), the dose of Paxlovid should be reduced.
- Note: Visit Pfizer Laboratories: Highlights of Prescribing Information to review updated labeling information with new dose recommendations for patients with severe renal impairment (GFR <30ml/min), including those requiring hemodialysis.
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.
References:
- FDA: Full Prescribing Information for Paxlovid (PDF)
- FDA: Frequently Asked Questions on the EUA for Paxlovid (PDF)
- CDC: Evaluation of SARS-CoV-2 RNA Rebound After Nirmatrelvir/Ritonavir Treatment in Randomized, Double-Blind, Placebo-Controlled Trials — United States and International Sites, 2021–2022
- CDC: SARS-CoV-2 Rebound With and Without Use of COVID-19 Oral Antivirals
- 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. Refer to IDSA: Molnupiravir: Guidelines on the Treatment and Management of Patients 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, refer to 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 available 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 (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
Patient Insurance Status: Commercial (private) insurance
Merck Co-Pay Savings Program
Savings coupon for LAGEVRIO™ (molnupiravir)
Eligible, privately insured patients may pay as little as $10 per prescription, up to a maximum program savings of $300 per patient.
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). Refer to IDSA: Remdesivir: Guidelines on the Treatment and Management of Patients 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
There is currently one monoclonal antibody (pemivibart, Pemgarda™) authorized for pre-exposure prophylaxis of COVID-19 patients with moderate to severe immune compromise. More information is below. There are currently no monoclonal antibodies authorized for use for the treatment of acute COVID-19 or post-exposure prophylaxis of COVID-19.
Pemgarda™ is a SARS-CoV-2 spike protein-directed attachment inhibitor that is authorized for pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years of age and older with moderate to severe immune compromise who are not expected to mount an adequate immune response to COVID-19 vaccination.
Pemgarda™ is not a substitute for vaccination. All persons, including those who are immunocompromised and their household members and close contacts, should stay up to date with COVID-19 vaccination.
Per FDA, eligibility for Pemgarda™ includes:
- Adults and adolescents (12 years of age or older AND weighing at least 40kg)
- The minimum body weight of 40kg applies to adolescents only.
- Who are not currently infected with SARS-CoV-2 and have not been known to be exposed to someone with SARS-CoV-2 AND
- Have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, and are unlikely to mount an adequate immune response to COVID-19 vaccination.
- For examples of conditions or treatments, visit FDA: Frequently Asked Questions on Pemgarda (PDF)
Pemgarda™ is not authorized for the treatment of COVID-19 or for post-exposure prophylaxis of COVID-19.
The authorized Pemgarda™ initial dose is 4500mg administered as a single IV infusion over a minimum of 60 minutes. If ongoing protection is needed, a repeat dose of 4500mg should be administered every 3 months. In individuals who have recently received a COVID-19 vaccine, Pemgarda™ should be administered at least 2 weeks after vaccination.
Anaphylaxis warning:
- Anaphylaxis has been observed with Pemgarda™ in 4/623 (0.6%) patients in a clinical trial, including during the first and second infusions.
- Pemgarda™ should only be administered in settings in which health care providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS) as necessary.
- Clinically monitor individuals during the infusion and for at least 2 hours after completion of the infusion and discontinue Pemgarda™ if signs or symptoms of anaphylaxis or severe systemic reaction are observed.
SARS-CoV-2 variants may emerge over time that are not neutralized by Pemgarda™. Patients at high risk for COVID-19 should continue to take prevention measures such as wearing a well-fitting mask and testing for COVID-19 if any signs or symptoms of a respiratory viral infection occur. Patients receiving Pemgarda™ may also be treated with available antivirals for COVID-19 such as Paxlovid, molnupiravir, or remdesivir if they develop COVID-19.
Pemgarda™ (pemivibart) is available via traditional commercial distributors. For patients with Medicare Part D, Centers for Medicare & Medicaid Services (CMS) rules prohibit cost-sharing for COVID-19 monoclonal antibody products, meaning that patients do not pay a copay/coinsurance or deductible. Review CMS: COVID-19 Monoclonal Antibodies for more details.
More information:
- 2024 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Management of COVID-19: Anti-SARS-CoV-2 Neutralizing Antibody Pemivibart for Pre-Exposure Prophylaxis (PDF)
- FDA Fact Sheet for Patients, Parents and Caregivers: Emergency Use Authorization of PEMGARDA (pemivibart) for COVID-19 (PDF)
- FDA Fact Sheet for Healthcare Providers: Emergency Use Authorization of PEMGARDA (pemivibart) (PDF)
- FDA Frequently Asked Questions on the Emergency Use Authorization for Pemgarda (pemivibart) for Pre-exposure Prophylaxis (PrEP) of COVID-19 (PDF)
- Health care professionals seeking to obtain Pemgarda™ for their patients should contact their primary vendor for ordering information or contact Invivyd at 1-800-890-3385 for more information.
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 IDSA: IL-6 Inhibitors: Guidelines on the Treatment and Management of Patients with COVID-19.
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 IDSA: Janus Kinase Inhibitors: Guidelines on the Treatment and Management of Patients with COVID-19.
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.