American Thoracic Society Releases Interim Guidance on Treatment of COVID-19, Including Discussion of Controversial Hydroxychloroquine Therapy

The American Thoracic Society (ATS) on April 3, 2020 published a guidance document providing several suggestions for treatment of COVID-19.  The document, entitled “COVID‐19: Interim Guidance on Management Pending Empirical Evidence,” was developed by an ATS-led international task force and addresses several recently publicized potential treatment regimens.  While the document explicitly does not constitute ATS’s official position on treatment of COVID-19 infections, the authors explain that it is intended to provide “interim guidance for therapeutic interventions to frontline clinicians, based upon scarce direct evidence, indirect evidence, and clinical observations and experiences of clinicians around the world who have battled COVID-19.”  The document’s “suggestions” were developed based on the survey responses of 80 clinicians who have been involved in treatment of COVID-19 around the world.

The guidance document addresses a number of potential therapeutic interventions as well as the circumstances and parameters under which those interventions may or may not be recommended for use.  The authors point toward the need to gather significantly more data on the proposed treatments, but acknowledge that, given the urgent need to find effective treatments for severe COVID-19 infections, providers will likely need to administer unproven treatments before results from clinical trials are available.  To further assist with assessing the efficacy and safety of various treatments, the authors call for the collection of data from patients who receive these interventions outside the context of clinical trials.  Ideally, such data would include detailed information about patient characteristics; the interventions administered; and the outcomes of the attempted treatments, including mortality, ICU length of stay, hospital length of stay, intubation rate, length of mechanical ventilation, need for long‐term oxygen therapy, and adverse events.

The ATS-issued guidance has gained publicity for its discussion of the much publicized but unproven and controversial use of hydroxychloroquine or chloroquine treatment for COVID-19 patients.  The guidance “suggests” use of these medications on a case-by-case, but only for a limited subset of hospitalized COVID-19 patients with evidence of pneumonia.  It stops far short of a full-throated endorsement of the treatment, noting that although several small trials have been conducted, those studies have significant limitations.  The guidance also points to concerns that physicians could be administering an ineffective medication with potentially fatal side effects, while causing shortages of the medication for those patients who require it for proven treatment of other health conditions

In suggesting a very limited application of the experimental hydroxychloroquine or chloroquine treatments, the guidance document proposes that such treatment only be used in extreme situations where:

  1. The patient’s pneumonia is “severe enough to warrant investigational therapy”;
  2. The patient is involved in the decision to initiate treatment after being made aware of the potential benefits and possible side effects;
  3. The patient is monitored for adverse effects of the treatment; and
  4. The threshold for discontinuing treatment because of adverse effects is set very low.

The authors urge that the suggested use of hydroxychloroquine or chloroquine treatment under certain extreme circumstances be regularly reassessed as more information about the treatment’s efficacy and safety becomes available.

In the days, weeks, and months to come, frontline healthcare providers will continue to face difficult decisions about when and whether to try novel applications of existing medications and treatments on patients suffering from COVID-19.  As discussed in a March 25, 2020 joint statement from the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists, providers will need to balance the desire to try certain medications for treatment of COVID-19 against the needs of patients who have long relied on the same medications for treatment of medical conditions (such as such as lupus or rheumatoid arthritis) for which their use has been proven effective.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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