Drugs Available Under Emergency Use Authorization

Paxlovid

About: Paxlovid is an oral drug developed for the treatment of COVID-19. Paxlovid can only be used within the first 5 days of symptoms and should be initiated as soon as possible.

For: The FDA has granted emergency use authorization for Paxlovid to be used for adults and adolescents 12 years and older with mild to moderate COVID-19.  Due to limited supply, Paxlovid will be prioritized for patients at highest risk for severe illness from COVID-19.

Availability: University of Michigan Health-West does not expect to receive Paxlovid initially when it becomes available in the State of Michigan in January. The drug is expected to be more widely available in the coming months.

Molnupiravir

About: Molnupiravir is an oral drug that must be taken within the first 5 days of symptoms.

For: Molnupiravir has been granted emergency use authorization for the treatment of COVID-19 of adults 18 years of age and older with mild to moderate COVID-19. It is prioritized for use with patients at high risk of severe illness from COVID-19, and for whom other authorized COVID-19 treatment options are not available or clinically appropriate.

Availability: University of Michigan Health-West does not expect to receive Molnupiravir initially when it becomes available in the State of Michigan in January.

EvuSheld

About: EvuSheld is a long-acting antibody combination that may help prevent serious illness from COVID-19. The drug is administered as two separate, consecutive injections, and is expected to last six months. EvuSheld is not a substitution for vaccinations and booster shots.

For: The FDA has granted emergency use authorization for the use of EvuSheld in immunocompromised adults and adolescents 12 years and older.  Compromised immunity could be due to a medical condition, or use of medications that suppress the immune system or reduce the chance of responding to COVID-19 vaccine.

EvuSheld is not authorized for people who are currently infected or have had recent exposure to COVID-19.

Availability: Supply of this drug is scarce, and its use will be prioritized for immunocompromised patients who are least likely to respond to COVID-19 vaccines. At University of Michigan Health-West, our Cancer Center and subspecialty clinics will be contacting patients who are identified as eligible for EvuSheld.

Monoclonal Antibodies

Monoclonal antibodies are produced in a laboratory and serve to enhance or mimic the immune system’s response to disease. Monoclonal antibodies are already used to treat other diseases, including cancer, rheumatoid arthritis, multiple sclerosis, and Crohn’s disease.

Sotrovimab: Due to the increase in the Omicron variant in our community, starting January 3rd, 2022 University of Michigan Health-West will only utilize the monoclonal antibody effective against Omicron, sotrovimab, for treatment of mild-moderate COVID-19 in patients at high risk for severe disease. Sotrovimab can only be given by infusion.

Availability: There is limited supply of this medication, which will impact availability for patients. Given this, post-exposure treatment is no longer available

Drugs with Full FDA Approval

Remdesivir

Remdesivir is a FDA-approved antiviral drug that works by blocking the virus from replicating in the body. University of Michigan Health-West has been using the treatment since the spring of 2020, since the drug received emergency use authorization and now with full FDA approval. It’s been demonstrated that patients who are hospitalized for moderate or severe COVID and treated with remdesivir tend to go home sooner.

However, so far the drug appears to have no effect on whether people die from COVID. And it appears to have no effect on patients with severe disease who are on high-flow oxygen or a mechanical ventilator.

Dexamethasone

Dexamethasone, a drug that is 60 years old, is a steroid that works by decreasing the body’s misdirected response to disease and is turning the tide for many patients with severe COVID-19. It has long been studied for the treatment of acute respiratory disease syndrome and sepsis.

The drug should not be given to outpatients as it can be harmful if given during an active viral infection, and it needs to be used with careful follow-up. This drug may also be harmful if given early in the course of the disease.

Other Treatments

Supplemental oxygen is standard of care for patients with low oxygen levels, and blood thinners are standard treatment to reduce the risks of blood clotting.

Other treatments have been shown over time to be ineffective, like hydroxychloroquine and ivermectin.

Early on, convalescent plasma, an old therapy where patients are given blood plasma from people who recovered from COVID-19 and generated antibodies against SARS-CoV-2, received emergency use authorization from the FDA. It was used by providers desperate to offer any therapy, but there is currently little good trial data to support its use and trials are still ongoing

Similarly, over-the-counter supplements like vitamin C, D, and zinc, currently have no evidence to support their use.

For more details about the treatments outlined above, visit the Michigan Health Blog post, “COVID-19 Therapies: Where Are We?“