There are no cures for COVID-19, but an increasing number of evidence-based treatments have been identified. Most of these have emergency use authorization, rather than full approval, from the Food and Drug Administration.
At the end of December 2021, the FDA authorized for emergency use the first oral antivirals for COVID-19, Pfizer’s Paxlovid and Merck’s molnupiravir. Both drugs are authorized for patients with mild-to-moderate COVID-19 who are at high risk of severe disease. The pills should be given as early as possible and no later than five days after symptoms begin.
Paxlovid consists of nirmatrelvir, a protease inhibitor that prevents replication of the coronavirus, or SARS-CoV-2; and ritonavir, a drug that slows breakdown of nirmatrelvir. Paxlovid was found in a randomized, double-blind, placebo-controlled clinical trial to reduce COVID-19-related hospitalization or death from any cause by 88% compared with a placebo after 28 days of follow-up.
Molnupiravir also prevents viral replication of SARS-CoV-2, but works in a different way, by introducing errors into the virus’s genetic code. It was shown in a randomized, double-blind, placebo-controlled clinical trial to reduce hospitalization or death from any cause by 30% compared with a placebo after 29 days.
While potentially revolutionary for COVID-19 treatment, the pills are not a substitute for vaccination and come with some risks. Paxlovid, for example, may not be suitable in people with kidney disease or those taking certain other drugs, while molnupiravir is not recommended for pregnant people.
One FDA-approved treatment for COVID-19 is remdesivir, an intravenous antiviral drug. It was approved in October 2020 for hospitalized patients 12 years and older based on randomized, controlled clinical trials that found faster recovery times and statistically significant odds of improving conditions among hospitalized patients with mild to severe COVID-19 who received the drug, compared with those who got a placebo plus standard care. Approval has since been extended to children as young as a month old and to nonhospitalized patients with mild to moderate COVID-19 who are at high risk of developing severe disease.
Two other FDA-approved drugs for COVID-19 are baricitinib and tocilizumab, immunomodulators traditionally used to treat diseases such as rheumatoid arthritis. For COVID-19, they’re approved for use in certain hospitalized patients, such as those needing ventilation, and are thought to help by tamping down overactive immune responses that can be harmful later in the disease progression.
Other therapies include monoclonal antibodies that target SARS-CoV-2, which the FDA has authorized for patients with mild to moderate disease who are at high risk for developing severe COVID-19. These drugs are synthetic antibodies that are designed to prevent the virus from entering cells, although some may not be effective against all variants of the coronavirus. As of Nov. 30, 2022, no antibodies are FDA-authorized because none are expected to work against the particular viral strains circulating.
Another key drug in the arsenal is the steroid dexamethasone, which was found in a large randomized controlled trial in the U.K. to provide a mortality benefit in hospitalized COVID-19 patients who were ventilated or receiving supplemental oxygen. The finding was announced in June 2020. Dexamethasone, however, did not help patients who weren’t receiving respiratory support, and may have harmed them.