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What You Need to Know About the Coronavirus (COVID‑19) Pandemic

Course Number: 652

Treatments

Hundreds of treatments are being developed and tested to prevent or treat COVID‑19. Many of these therapies that have received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) and there are those that are nearing approval. Remdesivir was approved by the FDA to treat COVID‑19 patients who are at least 12 years old and require hospitalization, but the WHO later recommended against its use.48 It was initially recommended that remesivir only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. The WHO issued “A conditional recommendation against the use of remdesivir in hospitalized patients on November 20, 2020, regardless of disease severity, as they stated that there is currently no evidence that remdesivir improves survival and other outcomes in these patients.47 The WHO states that, “a conditional recommendation is issued when the evidence around the benefits and risks of an intervention are less certain. In this case, there is a conditional recommendation against the use of remdesivir. This means that there isn’t enough evidence to support its use."49

The FDA issued an EUA for the Regeneron company’s product, REGEN-COV™ (casirivimab with imdevimab), an experimental medicine, to treat COVID‑19 in high-risk patients with mild to moderate disease, on November 21, 2020.50 The Regeneron treatment is a monoclonal antibody therapy to be used on COVID‑19 patients, including children and at-risk elderly, to help them avoid hospitalization. On November 23, 2020, the US Department of Health and Human Services also approved casirivimab and imdevimab antibody therapy for administration.51 Monoclonal antibodies are laboratory-made proteins that imitate the immune system’s capability to protect against toxic pathogens such as viruses. Casirivimab and imdevimab are monoclonal antibodies that are explicitly targeted against the spike protein of SARS‑CoV‑2, intended to block the virus’ attachment and entry into human cells.51

Dexamethasone is a common corticosteroid medication that has been used for many years to treat various health conditions, such as autoimmune conditions and allergic reactions. RECOVERY, a randomized clinical trial in the UK, is an ongoing investigation of many medications, including dexamethasone, to see if any are effective against COVID‑19.52 They concluded that, in patients hospitalized with COVID‑19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization.52 Increased survival rates were not seen in individuals with less severe disease who were not receiving respiratory support.52 The medication was most helpful for patients who were on a ventilator or needed supplemental oxygen in an inpatient setting. There was no statistically significant benefit that was determined for those with less severe symptoms.

The National Institutes of Health (NIH) has published The Coronavirus Disease 2019 (COVID‑19) Treatment Guidelines in an electronic format that can be updated when needed with the rapid pace and growing volume of information regarding the treatment of COVID‑19.53 On November 19, 2020, the FDA issued an EUA for the use of baricitinib in combination with remdesivir in hospitalized adults and children aged ≥2 years with COVID‑19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.54

On December 17, 2020, it was announced that investigational COVID‑19 therapeutics are to be evaluated in large clinical NIH trials enrolling people hospitalized with COVID‑19. The two randomized, controlled Phase 3 clinical trials have begun evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with moderate COVID‑19.55 Researchers are also testing older medications that are typically used to treat other conditions, to see if they are also effective for COVID‑19. Many people infected with COVID‑19 will have mild symptoms and can recover at home. The CDC recommends basic measures such as rest, hydration, and over-the-counter medicines such as acetaminophen. Patients with more serious symptoms such as trouble breathing, chest pain, or bluish lips or face should seek emergency medical care.