Guidelines for Treatment of COVID-19 - LECOM

Guidelines for Treatment of COVID-19

Thursday, 04 June 2020

Mattie Follen, PharmD; Abbey Krysiak, PharmD, BCPP

There are currently no clinically proven treatments for COVID-19; medications used are based on limited observational studies and their in vitro antiviral activity or anti-inflammatory effects.1 It is important for observational studies to occur during the epidemic to investigate treatment options; however, they often do not have concurrent controls, may have a significant risk of bias, and use surrogate outcomes like viral clearance rather than clinically important outcomes, such as patient improvement.1 Therefore, medications that are thought to be beneficial in vitro and during observational studies may later show no benefit during clinical trials.1

The Infectious Diseases Society of America (IDSA) published guidelines on the treatment and management of patients with COVID-19 in April 2020. The IDSA recommends the use of hydroxychloroquine/chloroquine therapy for patients with COVID-19 that have been admitted to the hospital, only in the context of a clinical trial. The evidence failed to show or exclude a beneficial effect of hydroxychloroquine on clinical progression, represented by radiological findings, of COVID-19 or on viral clearance; however, a higher proportion of patients treated with hydroxychloroquine experienced clinical improvement. Outcomes, such as mortality, rate of progression to acute respiratory distress syndrome (ARDS), and need for mechanical ventilation were not available. Several studies evaluated the addition of azithromycin to hydroxychloroquine; however, this combination provided indirect comparisons of failure of virologic clearance to hospital controls. Treatment with hydroxychloroquine and azithromycin could lead to adverse effects, such as QT prolongation, and should be carefully considered when choosing therapy. Additional randomized controlled trials (RCTs) are needed to investigate the use of hydroxychloroquine alone or in combination with azithromycin for the treatment of COVID-19.

The IDSA recommends the combination of lopinavir/ritonavir for patients admitted to the hospital with COVID-19, only in the context of a clinical trial. Studies suggest that this combination does not have a measurable antiviral effect; additional clinical trials are needed.

The use of corticosteroids for patients admitted to the hospital with COVID-19 is not recommended unless the infection has progressed to ARDS. A small subset of patients may develop ARDS from COVID-19 and there is no clear benefit and possibly potential harm from corticosteroid use, such as acquiring serious secondary infections. RCTs are needed to determine the dose, route, timing, duration of corticosteroid treatment, and potential harms to better guide their place in therapy. The guidelines state that patients previously on a steroid should continue therapy.

The IDSA also recommends the use of tocilizumab for patients admitted to the hospital with COVID-19, only in the context of a clinical trial. Treatment with tocilizumab may increase patients’ risk of serious secondary infections and hepatitis B reactivation. Other potential harms associated with tocilizumab use include anaphylaxis, severe allergic reaction, severe liver damage, hepatic failure, and intestinal perforation. Additional clinical trials are needed to determine the effectiveness of tocilizumab for COVID-19 treatment.

The guidelines conclude that the benefits of treatment with the proposed therapies is highly uncertain, and there are known harms associated with each agent; therefore, the outcome could potentially be negative with the use of these therapies. It has not been determined if the benefits outweigh the risks, so it would be ethical and practical to enroll patients with COVID-19 in clinical trials, rather than use clinically unproven therapies.1

 

References:

  1. Bhimraj A, Morgan RL, Shumaker AH, et al. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. [Internet]. 2020 April 11 [updated 2020 April 13]. Available from: https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/
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