April 22, 2020

NIH issues treatment guidelines for COVID-19

The National Institutes of Health (NIH) announced on April 21 that a panel of U.S. physicians, statisticians, and other experts has developed treatment guidelines for COVID-19. According to NIH, these guidelines, intended for healthcare providers, are based on published and preliminary data and the clinical expertise of the panelists. 

The guidelines consider two broad categories of therapies currently in use by healthcare providers for COVID-19: antivirals, and host modifiers and immune-based therapies. The COVID-19 Treatment Guidelines Panel noted that at present, no drug has been proven to be safe and effective for treating COVID-19. Summary recommendations are as follows:

  • There are insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19 - if chloroquine or hydroxychloroquine is used, clinicians should monitor the patient for adverse effects, especially prolonged QTc interval.
  • There are insufficient clinical data to recommend either for or against using the investigational antiviral drug remdesivir for the treatment of COVID-19.
  • Except in the context of a clinical trial, the Panel recommends against the use of the following drugs for the treatment of COVID-19:
    • The combination of hydroxychloroquine plus azithromycin because of the potential for toxicities.
    • Lopinavir/ritonavir (AI) or other HIV protease inhibitors because of unfavorable pharmacodynamics and negative clinical trial data.
  • 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.
  • There are insufficient clinical data to recommend either for or against the use of the following agents for the treatment of COVID-19:
    • Interleukin-6 inhibitors (e.g., sarilumab, siltuximab, tocilizumab).
    • 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:
    • Interferons because of lack of efficacy in treatment of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) and toxicity.
    • Janus kinase inhibitors (e.g., baricitinib) because of their broad immunosuppressive effect.

The guidelines also include recommendations concerning the use of concomitant medications. These include statins, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), and angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). Summary recommendations are as follows:

  • Persons with COVID-19 who are prescribed ACE inhibitors or ARBs for cardiovascular disease (or other indications) should continue these medications.
  • The Panel recommends against the use of ACE inhibitors or ARBs for the treatment of COVID-19 outside of the setting of a clinical trial.
  • The Panel recommends against the routine use of systemic corticosteroids for the treatment of mechanically ventilated patients with COVID-19 without acute respiratory distress syndrome (ARDS).
  • For mechanically ventilated patients with ARDS, there is insufficient evidence to recommend for or against the use of systemic corticosteroids. 
  • For adults with COVID-19 and refractory shock, the Panel recommends using low-dose corticosteroid therapy (i.e., shock reversal) over no corticosteroids.
  • The Panel recommends against the routine use of systemic corticosteroids for the treatment of COVID-19 in hospitalized patients, unless they are in the intensive care unit.
  • Oral corticosteroid therapy used prior to COVID-19 diagnosis for another underlying condition (e.g., primary or secondary adrenal insufficiency, rheumatological diseases) should not be discontinued. On a case-by-case basis, supplemental or stress-dose steroids may be indicated.
  • Inhaled corticosteroids used daily for patients with asthma and chronic obstructive pulmonary disease for control of airway inflammation should not be discontinued in patients with COVID-19.
  • The antenatal corticosteroids betamethasone and dexamethasone are known to cross the placenta and therefore are generally reserved for when administration is required for fetal benefit. Other systemic corticosteroids do not cross the placenta, and pregnancy is not a reason to restrict their use if otherwise indicated.The American College of Obstetricians and Gynecologists recommends against offering antenatal corticosteroids for fetal benefit in the late preterm period (34 0/7 weeks–36 6/7 weeks) because the benefits of antenatal corticosteroids in the late preterm period are less well established.  Modifications to care for these patients may be individualized, weighing the neonatal benefits of antenatal corticosteroid use with the risks of potential harm to the pregnant patient.
  • Persons with COVID-19 who are prescribed statin therapy for the treatment or prevention of cardiovascular disease should continue these medications.
  • The Panel recommends against the use of statins for the treatment of COVID-19 outside of the setting of a clinical trial.
  • Persons with COVID-19 who are taking NSAIDs for a co-morbid condition should continue therapy as previously directed by their physician.
  • The Panel recommends that there be no difference in the use of antipyretic strategies (e.g., with acetaminophen or NSAIDs) between patients with or without COVID-19.

The guidelines also describe the evaluation and stratification of patients based on their risk of infection and severity of illness. Special considerations for pregnant women and for children who are infected are also included in the guidelines.

In addition, the guidelines address a range of considerations for clinicians caring for the most critically ill hospitalized patients, including infection control procedures, hemodynamic and ventilatory support, and drug therapy.

NIH added that the guidelines will be updated often as new data are published in peer-reviewed scientific literature and other authoritative information emerges.

SOURCE: National Institutes of Health