Contrary to Guidelines, Corticosteroids Commonly Used Outside of Hospitals to Treat COVID-19

Corticosteroids (also called glucocorticoids or steroids) are antiinflammatory drugs. They are used to treat a wide range of conditions, including asthma, eczema and certain types of arthritis, to name a few.

Certain systemic (given orally or by injection) steroids — mainly dexamethasone (HEMADY), hydrocortisone (ALKINDI SPRINKLE, CORTEF, SOLU-CORTEF), methylprednisolone (DEPO-MEDROL, MEDROL, SOLU-MEDROL) and prednisone (RAYOS) — have received a lot of attention as potentially effective treatments for COVID-19.[1]

The Food and Drug Administration has not approved any systemic steroids to treat COVID-19. However, evidence from multiple randomized clinical trials has shown since June 2020 that systemic steroid therapy improves clinical outcomes and reduces mortality in hospitalized COVID-19 patients who require supplemental oxygen or mechanical ventilation.[2],[3] In contrast, the use of these medications in patients with mild-to-moderate COVID-19, who are typically treated at home and do not require oxygen therapy, is not beneficial and can be harmful.

Therefore, the National Institutes of Health’s COVID-19 Treatment Guidelines Panel (the Panel) since October 2020 has recommended the use of systemic steroids (primarily dexamethasone if available) for up to 10 days in adults who are hospitalized with severe COVID-19 and in need of oxygen therapy.[4],[5] The Panel also has recommended against the use of steroids in COVID-19 patients treated in outpatient settings.[6]

The Panel cautions that the use of systemic steroids is associated with serious adverse effects (including high blood sugar levels, neuropsychiatric symptoms [such as confusion, disorientation and mania][7] and infections) that can be difficult to detect outside of hospitals.[8]

Despite the Panel’s recommendations, a recent observational study found that substantial proportions of nonhospitalized COVID-19 patients were prescribed systemic steroids. This study was published in the May 24, 2022, issue of the Journal of the American Medical Association (JAMA).

The new JAMA study[9]

The researchers of the new study used administrative medical claims data from two databases: Medicare fee-for-service (the largest cohort of U.S. people aged 65 years or older) and the FDA’s Sentinel Rapid COVID-19 (a cohort of commercially insured Americans of all ages from some large integrated U.S. health care delivery systems).

From these databases, the researchers selected nonhospitalized COVID-19 patients (identified by having a COVID-19 diagnosis code or a positive laboratory test for the coronavirus that causes COVID-19 recorded on an outpatient or emergency department medical claim) from April 2020 to August 2021. The final study sample was comprised of approximately 576,900 Medicare patients and 766,100 Sentinel patients who did not have any subsequent related hospitalization within 14 days of their COVID-19 diagnosis or positive test. These patients also neither had COVID-19 in the prior 183 days nor used systemic steroids in the prior 90 days. The mean age was 75 years for patients in the Medicare cohort and 49 years for those in the Sentinel cohort.

Overall, 17% of the subjects in the Medicare cohort and 9% of those in the Sentinel cohort had received systemic steroids in an outpatient setting within 14 days of their COVID-19 diagnosis. Notably, systemic steroid use increased over time: from 2% at the beginning of the study in both cohorts to 21% and 14% by its end in the Medicare and Sentinel cohorts, respectively.

In more than half of the subjects in both cohorts, treatment with systemic steroids often started on the day of the COVID-19 diagnosis, largely through pharmacy dispensing rather than during health care visits. The most commonly used pharmacy-dispensed steroids were dexamethasone for patients in the Medicare cohort (44%) and prednisone for patients in the Sentinel cohort (34%).

Notably, the use of systemic steroids increased with age in the Sentinel cohort. Overall, the proportion of patients initiating systemic steroids in the South was higher than those in other U.S. regions.

Also, a substantial proportion of patients (45% in the Medicare cohort and 49% in the Sentinel cohort) were prescribed the antibiotic azithromycin (ZITHROMAX), often on the same day as systemic steroids. This is another troubling finding because the Panel recommends against the use of antibiotics outside of hospitals for the sole purpose of treating COVID-19.[10]

What You Can Do

Keep your COVID-19 vaccination up to date because it is the best way to prevent serious COVID-19 outcomes.

If you have COVID-19 symptoms, visit https://aspr.hhs.gov/TestToTreat or call 800-232-0233 to find a testing location that can treat you if you test positive.

If a health care professional determines that you have mild-to-moderate COVID-19 that can be treated at home but that you are at risk of severe COVID-19 outcomes, he or she may prescribe antiviral medications (such as nirmatrelvir and ritonavir [PAXLOVID]) or monoclonal antibodies.[11] However, to be effective, these medications must be initiated within the first several days after the onset of your COVID-19 symptoms.

Unless you are hospitalized with COVID-19 and require oxygen therapy, do not start taking any systemic steroids solely to treat COVID-19. However, if you have been taking a steroid medication for another condition before your COVID-19, continue to take that medication under medical supervision.
 

References

[1] National Institutes of Health. COVID-19 Treatment Guidelines Panel. COVID-19 treatment guidelines: Corticosteroids. May 31, 2022. https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/corticosteroids/. Accessed August 3, 2022.

[2] Ibid.

[3] RECOVERY Collaborative Group, Horby P, Lim WS, Emberson JR, et al. Dexamethasone in hospitalized patients with Covid-19. N Engl J Med. 2021;384(8):693-704.

[4] National Institutes of Health. COVID-19 Treatment Guidelines Panel. COVID-19 treatment guidelines: Therapeutic management of hospitalized adults with COVID-19. February 24, 2022. https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/hospitalized-adults--therapeutic-management/. Accessed August 3, 2022.

[5] National Institutes of Health. COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. October 9, 2020. https://files.covid19treatmentguidelines.nih.gov/guidelines/archive/covid19treatmentguidelines-10-09-2020.pdf. Accessed August 3, 2022.

[6] National Institutes of Health. COVID-19 Treatment Guidelines Panel. COVID-19 treatment guidelines: Therapeutic management of nonhospitalized adults with COVID-19. April 8, 2022. https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/nonhospitalized-adults--therapeutic-management/. Accessed August 3, 2022.

[7] Fardet L, Petersen I, Nazareth I. Suicidal behavior and severe neuropsychiatric disorders following glucocorticoid therapy in primary care. Am J Psychiatry. 2012;169(5):491-497.

[8] National Institutes of Health. COVID-19 Treatment Guidelines Panel. COVID-19 treatment guidelines: Corticosteroids. May 31, 2022. https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/corticosteroids/. Accessed August 3, 2022.

[9] Bradley MC, Perez-Vilar S, Chillarige Y, et al. Systemic corticosteroid use for COVID-19 in US outpatient settings from April 2020 to August 2021. JAMA. 2022;327(20):2015-2018.

[10] National Institutes of Health. COVID-19 Treatment Guidelines Panel. COVID-19 treatment guidelines: Therapeutic management of nonhospitalized adults with COVID-19. April 8, 2022. https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/nonhospitalized-adults--therapeutic-management/. Accessed August 3, 2022.

[11] Centers for Disease Control and Prevention. COVID-19 treatments and medications. April 29, 2022. https://www.cdc.gov/coronavirus/2019-ncov/your-health/treatments-for-severe-illness.html. Accessed August 3, 2022.