#15,210
Yesterday the National Institutes of Health (NIH) released treatment guidelines for COVID-19, part of what they are calling a `living document', that will be updated as more is learned from clinical trials currently underway.
Over the past couple of months we've seen numerous `forward looking' statements about potential therapeutic drugs - many of which are still in clinical trials - suggesting they may be effective against COVID-19. These include:
- Hydroxychloroquine (w/wo azithromycin)
- Remdesivir
- Convalescent Plasma
- Lopinavir/ritonavir (AI)
While the jury is still out on many of them, as of now, treatment is still primarily supportive, as no drug has been proven safe and effective in the treatment of COVID-19.
Therapeutic Options for COVID-19 Currently Under Investigation
Summary Recommendations
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.
A couple of therapeutic options - including hydroxychloroquine plus azithromycin - have already received a negative recommendation due to side effects.
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:
- The combination of hydroxychloroquine plus azithromycin (AIII) because of the potential for toxicities.
- Lopinavir/ritonavir (AI) or other HIV protease inhibitors (AIII) because of unfavorable pharmacodynamics and negative clinical trial data.
First, the link to the full NIH document, followed by the NIH announcement:
Coronavirus Disease 2019 (COVID-19)Treatment Guidelines
VIEW GUIDELINES
Expert U.S. panel develops NIH treatment guidelines for COVID-19
“Living document” expected to be updated often as new clinical data accrue.
A panel of U.S. physicians, statisticians, and other experts has developed treatment guidelines for coronavirus disease 2019 (COVID-19). These guidelines, intended for healthcare providers, are based on published and preliminary data and the clinical expertise of the panelists, many of whom are frontline clinicians caring for patients during the rapidly evolving pandemic.
The guidelines are posted online (covid19treatmentguidelines.nih.gov) and will be updated often as new data are published in peer-reviewed scientific literature and other authoritative information emerges.
The guidelines consider two broad categories of therapies currently in use by healthcare providers for COVID-19: antivirals, which may target the coronavirus directly, and host modifiers and immune-based therapies, which may influence the immune response to the virus or target the virus.
The panel’s conclusions about treating COVID-19 with various agents that fall into these two classes of therapies are distilled in summary recommendations. Subsequently, the document provides background information about each agent—such as clinical data about its use, ongoing clinical trials, and known interactions with other drugs—that forms the basis for the Recommendation. Tables briefly outline the same information.
The guidelines also describe the evaluation and stratification of patients based on their risk of infection and severity of illness. Recommendations in this section address best practices for managing patients at different stages of infection, for example:
- Outpatients who are either asymptomatic or who have mild to moderate symptoms and are self-isolating
Special considerations for pregnant women and for children who are infected are also included.
- Inpatients with severe illness or critical disease
A comprehensive section of the guidelines addresses a range of considerations for clinicians caring for the most critically ill hospitalized patients. This section includes multiple recommendations for patients needing critical care, including infection control procedures, hemodynamic and ventilatory support, and drug therapy.
Finally, the guidelines include recommendations concerning the use of concomitant medications. These include statins; corticosteroids; non-steroidal anti-inflammatory drugs; and certain drugs used to control hypertension, known as ACE inhibitors and ARBs.
The treatment guidelines panel is co-chaired by Roy M. Gulick, M.D., chief of the Infectious Disease Division at Weill Medical Hospital of Cornell University, New York City; H. Clifford Lane, M.D., clinical director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health; and Henry Masur, M.D., chief of the Critical Care Medicine Department at the NIH Clinical Center. Members of the guidelines panel, appointed by the co-chairs, were chosen based on their clinical experience and expertise in patient management, translational and clinical science, and/or the development of treatment guidelines. They include 30 experts drawn from U.S. healthcare and academic organizations, federal agencies, and professional societies.
