There are no cures for COVID-19. So far, only a few evidence-based treatments are available.
One is the antiviral drug remdesivir, which received approval from the Food and Drug Administration in October for COVID-19 patients requiring hospitalization. The FDA based its approval on randomized, controlled clinical trials that found faster recovery times and statistically significant odds of improving conditions among patients with mild to severe COVID-19 who received the drug, compared with those who got a placebo plus standard care.
That’s the only FDA-approved treatment, but the agency has granted emergency use authorization to others. For instance, it has authorized the use of convalescent plasma — which is plasma, the part of blood that contains antibodies, from people who have recovered from COVID-19. In a March 9 letter, the FDA said the EUA was for the use of convalescent plasma with a high level of antibodies “for the treatment of hospitalized patients with COVID-19, early in the course of disease.” It noted “the clinical evidence supporting this EUA remains limited” and encouraged health care providers to enroll patients in ongoing clinical trials.
The FDA also has granted EUAs to monoclonal antibody treatments, which are synthetic antibodies, for patients with mild to moderate disease who are “at high risk for progressing to severe COVID-19 and/or hospitalization.” The EUAs said it was “reasonable to believe” the treatments “may be effective,” based on ongoing randomized, controlled clinical trials.
And, the agency has issued an EUA for the use of baricitinib, a drug used to treat rheumatoid arthritis, in combination with remdesivir in hospitalized patients who require ventilation or supplemental oxygen. That decision was based on a randomized, controlled clinical trial that found faster recovery times and better odds of improvement with the drug combination.
Also, a randomized controlled trial in the U.K. found that the steroid dexamethasone provided a mortality benefit in hospitalized COVID-19 patients who were ventilated or receiving supplemental oxygen. The finding was announced in June 2020. The drug did not help patients who weren’t receiving respiratory support, and may have harmed them.