NIH Releases Guidelines for the Treatment of Patients with COVID-19

The National Institutes of Health (NIH) for the first time Tuesday unveiled treatment guidelines for clinicians treating patients with coronavirus disease 2019 (COVID-19).

The guidelines distill the existing and evolving knowledge of the US medical community with regard to the diagnosis and treatment of COVID-19; however, they also highlight the lack of clear and convincing data to support any specific therapy.

The guidelines were constructed by a panel of physicians, statisticians, and other experts. The panel was chaired by Roy M. Gulick, MD, chief of the Infectious Disease Division at Weill Medical Hospital of Cornell University; H. Clifford Lane, MD, clinical director of the National Institute of Allergy and Infectious Diseases; and Henry Masur, MD, chief of the Critical Care Medicine Department at the NIH Clinical Center.

The recommendations cover patients at all stages of the symptom spectrum, from those who are asymptomatic to those with critical illness. The guidelines also include recommendations specifically for children, pregnant women, and people taking other medications.

The panel does not recommend any kind of prophylaxis—either before or after exposure—outside of a clinical trial setting. They note, however, that trials are currently underway for a handful of possible prophylactics, including the much-discussed hydroxychloroquine and chloroquine.

Likewise, the panel says no existing antiviral has been proven an effective treatment against COVID-19, even though a number are currently being used in clinics around the world. They note that chloroquine and hydroxychloroquine are available from the Strategic National Stockpile under an emergency use authorization for hospitalized adults and adolescents weighing greater than 50 kilograms.

“An array of drugs approved for other indications, as well as multiple investigational agents, are being studied for the treatment of COVID-19 in several hundred clinical trials around the globe,” they add. “Some drugs can be accessed through expanded access or compassionate use mechanisms.”

In addition to antivirals, the guidelines also discuss host modifiers and immune-based therapies. However, these too, have yet to be scientifically proven effective in fighting COVID-19, the panel said.

The panel says patients with asymptomatic or presymptomatic COVID-19 ought to self-isolate, but don’t require treatment as long as their condition remains the same. If a patient remains asymptomatic 7 days after their first positive SARS-CoV-2 test, they can discontinue isolation, the panel said.

Patients with mild illness ought to be monitored, but don’t require any specific laboratory testing if they are otherwise healthy, according to the guidelines.

Patients with clinical assessment or imaging with SpO₂ >93% on room air at sea level can be categorized as having “moderate” illness, and ought to be admitted to the hospital due to the potential for the disease to rapidly progress, the panel said. It’s not yet known which imaging technology is optimal to assess such patients, but chest x-rays, ultrasounds, and CT scans are all viable options, according to the document.

The panel said patients have “severe” illness if they have SpO₂ ≤93% on room air at sea level, respiratory rate >30, PaO₂/FiO₂ <300, or lung infiltrates >50%. Such patients should be given oxygen therapy immediately and placed in airborne infection isolation rooms (AIIRs), if available.

Finally, the recommendations say patients with acute respiratory disease syndrome, septic shock, cardiac dysfunction, and other sever symptoms can be considered critical.

“Currently, there is limited information to suggest that the critical care management of patients with COVID-19 should differ substantially from the management of other critically ill patients,” the guidelines state, “although special precautions to prevent environmental contamination by SARS-CoV-2 is warranted.”

The full list of guidelines, including precautions for those on concomitant medications, can be accessed at the NIH’s website. The panel said it will update the guidelines as new information and data become available.