Update Alert 2: 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

This letter serves to retire the American College of Physicians' (ACP) rapid, living practice points on the use chloroquine or hydroxychloroquine alone or in combination with azithromycin for the prophylaxis or treatment of coronavirus disease 2019 (COVID-19) (1, 2) from the living status. This decision was made in light of recent information on the topic. Three large, in-progress randomized controlled trials (RCTs) with strong study designs ceased enrollment for the hydroxychloroquine-only versus control comparison early due to lack of efficacy in preliminary analyses (3–5). In addition, the 2 literature updates produced no evidence to alter these conclusions. The U.S. Food and Drug Administration also recently revoked its emergency use authorization for chloroquine and hydroxychloroquine for the treatment of COVID-19 due to potential significant harms and lack of benefits (6). The ACP's Scientific Medical Policy Committee (SMPC) has determined that the emergence of new evidence is unlikely to change the existing practice points; therefore, regularly scheduled updates are no longer warranted. The SMPC will continue to review the planned ongoing surveillance through November 2020 (7). The updated evidence review (8) identified 1 new RCT (9), 5 new cohort studies (10–14), and published reports of studies previously available as preprints, which resulted in changes in rating of the risk of bias (15, 16). A sixth newly published large cohort study was identified but not considered further because it was retracted due to concerns about the veracity of the data (17, 18). The newly available evidence has high risk of bias and showed conflicting direction and magnitude of results, leading to unchanged conclusions from the initial review with insufficient evidence to support the effectiveness or safety of chloroquine or hydroxychloroquine alone or in combination with azithromycin for the treatment of COVID-19 in hospitalized patients. Furthermore, 3 RCTs were stopped early (3–5) and no data were available to assess from those RCTs.

Practice Points

• 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).