Therapeutic Options for COVID-19 Patients - Minnesota Dept. of Health
As we learn more about COVID-19, recommendations and guidance are updated frequently. Please check back often.

Therapeutic Options for COVID-19 Patients

Information about investigational medication treatments (therapeutics), to be updated as new information emerges.

The Minnesota Resource Allocation Platform (MNRAP) is an online tool that connects patients and health care providers with COVID-19 medications. Learn more at COVID-19 Medication Options.

In situations where demand for treatment is higher than supply, MDH recommends using the M-MASS score (Monoclonal Antibody Screening Score), which is a score developed by the Mayo Clinic and subsequently modified by MDH to identify patients at highest risk for severe illness. The score may be calculated using this online calculator: COVID-19 Monoclonal Antibody Therapy and Risk of Hospitalization. MDH also recommends prioritizing pregnant patients. Refer to "Prioritization note" below.

On this page:
Ethical guidance and eligibility
Monoclonal antibody (mAb) treatment
    Monoclonal antibody treatment and SARS-CoV-2 variants
    Regeneron – REGEN-COV (Casirivimab and Imdevimab)
    Lilly – Bamlanivimab and Etesevimab
    GSK – Sotrovimab
    AstraZeneca – Evusheld (Tixagevimab/Cilgavimab)
Oral antivirals
Remdesivir
Convalescent plasma
Tocilizumab
Baricitinib
Ventilators and cardiopulmonary resuscitation

As of Jan. 11, 2022, CDC estimates that the Omicron variant (B.1.1.529) remains the dominant variant in the United States and accounts for 98% of new U.S. COVID-19 cases. HHS has issued guidance to states that once the prevalence of the Omicron variant (B.1.1.5.2.9) in a jurisdiction reaches 20%, due to reduced effectiveness of bamlanivimab/etesevimab and casirivimab/imdevimab against Omicron, only sotrovimab should be used. As of Jan. 11, 2022, CDC estimates the prevalence of the Omicron variant in HHS Region 5 (which includes Minnesota) to be 97% (please refer to CDC COVID Data Tracker: Variant Proportions). Therefore, given the lack of efficacy of bamlanivimab/etesevimab and casirivimab/imdevimab against Omicron, MDH recommends that only sotrovimab should be used.

Ethical guidance and eligibility

Monoclonal antibody (mAb) treatment

Monoclonal antibody treatments are available through Food and Drug Administration (FDA) emergency use authorizations (EUA) for the prevention and treatment of illness due to COVID-19 in nonhospitalized people.

When demand for monoclonal antibody (mAb) treatments increases, the Minnesota health care system works to prioritize access to the treatments to people who are most at risk of severe illness.

  • The Minnesota Department of Health has worked closely with the Mayo Clinic and the University of Minnesota to look at who benefits from monoclonal antibody treatment. When a lot of COVID-19 is in the community and demand for the treatments is high, priority will be given first to treating patients who are ill and who have the highest risk of developing severe illness and requiring hospital admission. This means that some patients who are eligible for treatment will be notified that an appointment is not immediately available. Patients should remain in contact with their provider and watch closely for any symptoms.
  • MDH uses a modified Monoclonal Antibody Screening Score (M-MASS) for MNRAP, which is a score adapted from Mayo Clinic's published Monoclonal Antibody Screening Score (MASS). The M-MASS is calculated as follows, on a scale of 0-19: age 65 years and older (2 points), BMI 35 kg/m2 and higher (2), diabetes mellitus (2), chronic kidney disease (3), cardiovascular disease in a patient 55 years and older (2), chronic respiratory disease in a patient 55 years and older (3), hypertension in a patient 55 years and older (1), and immunocompromised status (4). Immunocompromised status was given 3 points in the original MASS score developed by the Mayo Clinic; however, after consultation with clinical advisers and review of data from the University of Minnesota, MDH modified the score to update the weighting to 4 points. MDH has recommended that sites deprioritize lower M-MASS scores in response to appointment scarcity, as described in the Ethical Framework for Allocation of Monoclonal Antibodies during the COVID-19 Pandemic (PDF).
  • Patients who are pregnant are also clinically prioritized, independent of the M-MASS score. This is based on review of data on pregnancy and the risk of severe COVID-19 that was used to determine a weighting that would provide relatively equivalent access to treatment in relation to the MASS scoring system.
  • During times of high demand, those who have been exposed but do not have symptoms may not have access to monoclonal antibodies for prevention of COVID-19 until case counts and demand for monoclonal antibody treatment decreases. People who have been exposed should be in contact with their provider and watch closely for any symptoms. If symptoms develop and they test positive for COVID-19, they may then seek treatment.
  • This prioritization framework applies to patients aged 18 years and older. Children who are eligible for mAb treatment under the current FDA guidance should continue to be assessed and treated. Refer to Suggested Criteria for the Use of Monoclonal Antibody Therapy for COVID-19 in Children (PDF).

This approach was developed by MDH in consultation with the Minnesota COVID-19 Ethics Collaborative and the MDH Science Advisory Team, similar to previous guidance on scarce therapeutics. Full details are available at Ethical Framework for Allocation of Monoclonal Antibodies during the COVID-19 Pandemic (PDF).

  • Aged 65 years or older
  • Obesity (BMI of 35 kg/m2 or greater)
  • Diabetes
  • Chronic kidney disease
  • Cardiovascular disease (disease of the heart and blood vessels as one body system) in patients aged 55 years or older
  • Chronic lung disease in patients aged 55 years or older
  • Hypertension (high blood pressure) in patients aged 55 years or older
  • Immunocompromised (hard to fight off or unable to fight off disease)
  • Pregnancy

Monoclonal antibody treatment and SARS-CoV-2 variants

Certain circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Health care providers should review the viral neutralization data in the authorized fact sheets for each mAb available under EUA for details regarding specific variants and resistance (see below). Information on the proportion of SARS-CoV-2 variants circulating in the U.S. is available on CDC COVID Data Tracker: Variant Proportions and will be updated regularly.

Please note that although sequencing information is helpful on a population level, individual patient results will not be reported back to the provider or submitting laboratory. Whole genome sequencing is not currently approved for use as a diagnostic test to make individual patient treatment decisions. In addition, the lengthy turnaround time for this type of testing means it is unsuitable for treatment decisions involving mAbs, which should be given as soon as possible once a patient has developed symptoms and tests positive.

Regeneron – REGEN-COV (Casirivimab and Imdevimab)

REGEN-COV is available for use through U.S. Health and Human Services (HHS) allocation and distribution.

  • Regeneron: Authorized for FDA Emergency Use only Casirivimab and Imdevimab
    Website of the manufacturer of casirivimab and imdevimab. Visit additional links, resources, and guidance to facilities administering the treatment, including:
    • FDA letter of authorization
    • Fact sheet for U.S. health care providers
    • Fact sheet for patients and caregivers in English and Spanish
    • Dear Healthcare Provider letter (prescribing information)
    • Resources for Healthcare Providers
      Includes information on packaging and preparation of casirivimab and imdevimab

REGEN-COV is authorized for both treatment and post-exposure prophylaxis and can be administered by IV or SQ routes. REGEN-COV is NOT thought to be effective against the Omicron variant.

Lilly – Bamlanivimab and Etesevimab

Bamlanivimab/etesevimab is available for use through HHS allocation and distribution. Etesevimab may be shipped alone for combination with existing supplies of bamlanivimab or as a combination product.

Bamlanivimab/etesevimab is authorized for both treatment and post-exposure prophylaxis and can ONLY be administered by IV route. Bamlanivimab/etesevimab is NOT thought to be effective against the Omicron variant.

GSK – Sotrovimab

Sotrovimab is both commercially available for purchase and available through HHS.

Sotrovimab is authorized for the treatment of mild to moderate COVID-19 ONLY and can ONLY be administered by IV route. Sotrovimab IS thought to be effective against the Omicron variant.

AstraZeneca – Evusheld (Tixagevimab/Cilgavimab)

Tixagevimab/cilgavimab will be available for use through HHS allocation and distribution. It is not yet available but is expected to begin shipping to states shortly. It is expected to be in extremely short supply and available only through clinical locations serving immunocompromised patients.

  • AstraZeneca: Evusheld (tixagevimab/cilgavimab)
    Website of the manufacturer of tixagevimab/cilgavimab. Visit additional links, resources, and guidance to facilities administering the treatment, including:
    • FDA letter of authorization
    • Fact sheet for U.S. health care providers
    • Fact sheet for patients and caregivers in English
  • FDA: Evusheld Letter of Authorization (PDF)
    Letter for emergency use authorization of tixagevimab/cilgavimab, updated Dec. 20, 2021.

Refer to the Ethical guidance and eligibility section for MDH guidance on allocation and distribution of tixagevimab/cilgavimab to treatment facilities and patients, including details of clinical prioritization of patients at highest risk. Please be aware that given the scarcity, not all patients currently eligible under the EUA will be able to access treatment, and those who are at the highest clinical risk of severe illness from COVID-19 will need to be prioritized. Providers with questions about the availability of tixagevimab/cilgavimab should contact the patient’s specialist provider for information.

Tixagevimab/cilgavimab likely retains some activity against the Omicron variant but full data are not yet available. Patients receiving tixagevimab/cilgavimab should be counseled about continuing all other COVID-19 mitigation efforts including vaccination of family and caregivers; diligent, high-quality mask wearing in indoor public areas; and avoidance of large gatherings.

Oral antivirals

New oral antivirals for the treatment of COVID-19 include molnupiravir and nirmatrelvir/ritonavir (Paxlovid). These have received emergency use authorization from the FDA, and limited amounts are being allocated to states. These therapies are for the treatment of mild to moderate COVID-19 in outpatients and are not authorized for the treatment of patients hospitalized due to COVID-19 or for pre- or post-exposure prophylaxis.

Nirmatrelvir/ritonavir (Paxlovid)

  • Nirmatrelvir/ritonavir is an oral antiviral treatment that combines 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. It is authorized for the treatment of mild-to-moderate COVID-19 in patients at high risk for severe illness from COVID-19. Treatment must be started within five days of symptom onset and is given as a five-day treatment course. In the EPIC-HR trial, ritonavir-boosted nirmatrelvir (Paxlovid) reduced the risk of hospitalization or death by 88% compared to placebo in nonhospitalized adults with laboratory-confirmed SARS-CoV-2 infection.

NOTE: 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 (see 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. Please refer to the FDA: Fact Sheet for Providers below and the NIH COVID-19 Treatment Guidelines Panel Statement on Paxlovid Drug-Drug Interactions, also linked below.

Molnupiravir

  • Molnupiravir is an oral nucleoside analogue that inhibits SARS-CoV-2 replication by inducing viral mutagenesis. It is authorized for the treatment of mild to moderate COVID-19 in patients at high risk for severe illness from COVID-19. Treatment must be started within five days of symptom onset and is given as a five-day treatment course. In the MOVe-OUT trial, molnupiravir reduced the rate of hospitalization or death by 30% compared to placebo.

NOTE: 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.

  • FDA: Fact Sheet for Healthcare Providers: Emergency Use Authorization for Molnupiravir

Remdesivir

Remdesivir is approved by the FDA under the name Veklury for the treatment of COVID-19 in hospitalized adult and pediatric patients (ages 12 years and older and weighing 40 kg or more). It is also available through an FDA emergency use authorization (EUA) for the treatment of COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg, or age 11 years and younger and weighing  3.5 kg or more.

Remdesivir has also been studied in non-hospitalized patients with mild to moderate illness who are at high risk of progressing to more severe illness. A clinical trial (PINETREE) showed that three consecutive days of IV remdesivir resulted in an 87% reduction in the risk of hospitalization or death compared to placebo. Based on this data, NIH has recommended its use as a treatment option if other therapies such as Paxlovid or sotrovimab are not available.

  • Dosing is 200mg IV on day 1, followed by 100mg IV once daily on days 2 and 3
  • Treatment should be initiated as soon as possible as within seven days of symptom onset

While remdesivir is currently FDA-approved for hospitalized patients, use for outpatient treatment would be considered an off-label indication. As remdesivir is not a federal asset being distributed by the U.S. Department of Health and Human Services, use in this manner may not be covered by insurance. Patients should be informed of this and facilities should work with patients to assist them with any insurance coverage issues, such as providing documentation of the need for therapy and citing recommendations from NIH and MDH as needed.

Convalescent plasma

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

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:

Baricitinib

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:

Ventilators and cardiopulmonary resuscitation


Thank you for your continued partnership. For health care questions, please contact the MDH provider hotline at 651-201-5414.

Updated Tuesday, 18-Jan-2022 12:59:23 CST