Update Alert: Should Clinicians Use Chloroquine or Hydroxychloroquine Alone or in Combination With Azithromycin for the Prophylaxis or Treatment of COVID-19? Living Practice Points From the American College of Physicians

In this letter, we update the American College of Physicians' previous practice points about chloroquine or hydroxychloroquine alone or in combination with azithromycin for prophylaxis or treatment of coronavirus disease 2019 (COVID-19) (1), using an updated evidence review conducted on 8 May 2020 (2). The evidence update identified 6 new studies: 4 observational studies (3–6) addressed use of hydroxychloroquine alone, 1 observational study (7) focused on hydroxychloroquine alone and in combination with azithromycin, and 1 observational study (8) assessed use of chloroquine alone (previously, no studies were available on the use of chloroquine alone). All new studies evaluated use of the pharmacologic interventions for treatment of COVID-19. The new evidence added support to previous conclusions but resulted in no conceptual changes to the practice points (see the next section and the Table). The Supplement summarizes the evidence, evidence gaps, and clinical considerations.

Table. Evidence Summary: What Information Does the Evidence Provide?*.

Practice Points: These interim practice points are based on the best available evidence. We will maintain these practice points as a living guidance document that will be updated as new evidence becomes available.

• Do not use chloroquine or hydroxychloroquine alone or in combination with azithromycin as prophylaxis against COVID-19.

• Do not use chloroquine or hydroxychloroquine alone or in combination with azithromycin as a treatment of patients with COVID-19.

• Clinicians may choose to treat hospitalized COVID-19–positive patients with chloroquine or hydroxychloroquine alone or in combination with azithromycin in the context of a clinical trial, using shared and informed decision making with patients (and their families).

Rationale for Prophylaxis: There continues to be no available evidence about the benefits and harms of use of chloroquine or hydroxychloroquine alone or in combination with azithromycin for prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, both chloroquine and hydroxychloroquine are associated with harms in patients without COVID-19. In the absence of evidence in patients with COVID-19, the risk for known harms in patients without COVID-19 outweighs the potential of any unknown benefit to prevent SARS-CoV-2 infection.

Rationale for Treatment: The evidence remains very uncertain about the benefits and harms of use of chloroquine or hydroxychloroquine alone or in combination with azithromycin for treatment of COVID-19, even with the new studies about the benefits and harms of chloroquine alone or hydroxychloroquine alone or in combination with azithromycin. There is still no available evidence about the benefits and harms of use of chloroquine in combination with azithromycin. Both chloroquine and hydroxychloroquine are associated with harms in patients without COVID-19. In light of very uncertain evidence on the benefit for the treatment of COVID-19, the risk for known harms outweighs the potential for unknown benefit. However, clinicians may choose to treat hospitalized COVID-19–positive patients with chloroquine or hydroxychloroquine alone or in combination with azithromycin in the context of a clinical trial using shared and informed decision making with patients and their families. These hospitalized patients will need to be carefully and closely monitored for any potential harms.

Biography

Note: The Practice Points are developed by the Scientific Medical Policy Committee of the American College of Physicians. The Practice Points are “guides” only and may not apply to all patients and all clinical situations. All Practice Points are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.

Financial Support: Financial support for the development of the Practice Points comes exclusively from the ACP operating budget.

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M20-3862. All financial and intellectual disclosures of interest were declared, and potential conflicts were discussed and managed. A record of disclosures of interest and management of conflicts is kept for each Scientific Medical Policy Committee meeting and conference call and can be viewed at https://www.acponline.org/about-acp/who-we-are/leadership/boards-committees-councils/scientific-medical-policy-committee/disclosure-of-interests-and-conflict-of-interest-management-summary-for-scientific-medical-policy.

Corresponding Author: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, aqaseem@acponline.org.