NIH Panel Develops COVID-19 Treatment Guidelines

A panel of experts convened by the US National Institutes of Health (NIH) has published treatment guidelines for the coronavirus disease 2019 (COVID-19), providing clinical recommendations for a number of therapeutic options that are currently under investigation.

Importantly, the guidelines emphasize that, even though there are several therapies being tested as potential treatments, no drug has been proven to be safe and effective for treating COVID-19. Investigational antiviral agents and host modifiers and immune-based therapies were included in the guidance.

With no sufficient clinical data available, the guidelines did not recommend either for or against the use of chloroquine or hydroxychloroquine for the treatment of COVID-19. However, they did recommend against the use of hydroxychloroquine in combination with azithromycin, except in the context of a clinical trial, due the potential for toxicities.

According to the panel, “the combination of hydroxychloroquine and azithromycin was associated with QTc prolongation in patients with COVID-19,” based on small randomized trials and in some case series.

Hydroxychloroquine, perhaps one of the more well-known therapies under investigation that has been touted by President Trump as a promising option, is being investigated by the NIH in a clinical trial. Although preliminary reports have implicated the drug’s use in treating patients with COVID-19, clinical trial data is needed to determine its safety and efficacy in this setting.

According to guidelines, the panel recommends against the use of:

• Lopinavir/ritonavir or other HIV protease inhibitors, because of “unfavorable pharmacodynamics and negative clinical trial data”

• Interferons because of “lack of efficacy in treatment of severe acute respiratory syndrome and Middle East respiratory syndrome and toxicity”

• Janus kinase inhibitors (eg baricitinib) because of their “broad immunosuppressive effect”

• Angiotensin-converting enzyme (ACE) inhibitors or angiotension-receptor blockers (ARBs) for the treatment of the virus outside of a clinical trial setting

• Systemic corticosteroids for the treatment of mechanically ventilated patients with COVID-19 without acute respiratory distress syndrome

• Systemic corticosteroids in hospitalized patients with COVID-19, unless they are in the intensive care unit

• Offering antenatal corticosteroids for fetal benefit in the late preterm period

• Statins for the treatment of COVID-19 outside of the clinical trial setting

For most of the other investigational therapies mentioned, including remdesivir, the panel did not make a determination on whether they should be used, pointing out insufficient scientific evidence. Remdesivir is currently being tested in clinical trials and is also available through expanded access and compassionate use mechanisms.

“There are insufficient data to recommend either for or against the use of any antiviral or immunomodulatory therapy in patients with COVID-19 who have mild, moderate, severe, or critical illness,” the guidelines stated.

According to the NIH, the guidelines will be updated often as new data are published and additional information emerges.

The full guidelines can be found online. 

References:

1. COVID-19 Treatment Guidelines. National Institutes of Health; April 21, 2020. Accessed April 21, 2020. https://covid19treatmentguidelines.nih.gov/introduction/

2. Expert US panel develops NIH treatment guidelines for COVID-19. News Release. NIH; April 21, 2020. Accessed April 21, 2020. https://www.nih.gov/news-events/news-releases/expert-us-panel-develops-nih-treatment-guidelines-covid-19