CORONAVIRUS PANDEMIC UPDATE: NIH COVID-19 TREATMENT GUIDELINES
These Treatment Guidelines have been developed to inform clinicians how to care for patients with COVID-19. Because clinical information about the optimal management of COVID-19 is evolving quickly, these Guidelines will be updated frequently as published data and other authoritative information becomes available.
The recommendations in these Guidelines are based on scientific evidence and expert opinion. Each recommendation includes two ratings: a letter (A, B, or C) that indicates the Strength of the Recommendation and a Roman numeral (I, II, or III) that indicates the Quality of the Evidence that supports the recommendation.
Strength of Recommendation
A: Strong recommendation for the statement
B: Moderate recommendation for the statement
C: Optional recommendation for the statement
Quality of Evidence for Recommendation
I: One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
II: One or more well-designed, nonrandomized trials or observational cohort studies
III: Expert opinion
At present, no drug has been proven to be safe and effective for treating COVID-19. There are no Food and Drug Administration (FDA)-approved drugs specifically to treat patients with COVID-19. Although reports have appeared in the medical literature and the lay press claiming successful treatment of patients with COVID-19 with a variety of agents, definitive clinical trial data are needed to identify optimal treatments for this disease. Recommended clinical management of patients with COVID-19 includes infection prevention and control measures and supportive care, including supplemental oxygen and mechanical ventilatory support when indicated. As in the management of any disease, treatment decisions ultimately reside with the patient and their health care provider.
· There are insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19 (AIII).
o If chloroquine or hydroxychloroquine is used, clinicians should monitor the patient for adverse effects, especially prolonged QTc interval (AIII).
· There are insufficient clinical data to recommend either for or against using the investigational antiviral drug remdesivir for the treatment of COVID-19 (AIII).
o Remdesivir as a treatment for COVID-19 is currently being investigated in clinical trials and is also available through expanded access and compassionate use mechanisms for certain patient populations.
· Except in the context of a clinical trial, the COVID-19 Treatment Guidelines Panel (the Panel) recommends against the use of the following drugs for the treatment of COVID-19:
o The combination of hydroxychloroquine plus azithromycin (AIII) because of the potential for toxicities.
o Lopinavir/ritonavir (AI) or other HIV protease inhibitors (AIII) because of unfavorable pharmacodynamics and negative clinical trial data.
Host Modifiers/Immune-Based Therapy:
· There are insufficient clinical data to recommend either for or against the use of convalescent plasma or hyperimmune immunoglobulin for the treatment of COVID-19 (AIII).
· There are insufficient clinical data to recommend either for or against the use of the following agents for the treatment of COVID-19 (AIII):
o Interleukin-6 inhibitors (e.g., sarilumab, siltuximab, tocilizumab)
o Interleukin-1 inhibitors (e.g., anakinra)
· Except in the context of a clinical trial, the Panel recommends against the use of other immunomodulators, such as:
o Interferons (AIII), because of lack of efficacy in treatment of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) and toxicity.
o Janus kinase inhibitors (e.g., baricitinib) (AIII), because of their broad immunosuppressive effect.