No New Revelation on Hydroxychloroquine and COVID-19

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, based on the findings of randomized controlled trials, it has authorized the use of several monoclonal antibodies that target SARS-CoV-2 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.

Another key drug in the limited 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.

The FDA has also issued EUAs for two immune modulating drugs, tocilizumab and baricitinib, for use in certain patients who are hospitalized, in combination with other drugs. Both drugs are used to treat rheumatoid arthritis and are thought to help by tamping down an overactive immune system later in the disease progression.

Baricitinib was authorized in combination with remdesivir for 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. Tocilizumab was authorized for patients taking systemic corticosteroids, such as dexamethasone, who need supplemental oxygen or ventilation.

Convalescent plasma, or the part of the blood that contains antibodies from people who have recovered from COVID-19, has also been studied as a potential treatment. In February 2021, the FDA  its EUA to include only plasma with a high concentration of antibodies “for the treatment of hospitalized patients early in the disease course,” following studies that found no benefit with lower antibody amounts. In a March 9 letter, the FDA  that “the clinical evidence supporting this EUA remains limited” and do not currently recommend convalescent plasma for any patient group.