key: cord-0930607-3wrl3kf4
authors: Qaseem, Amir; Yost, Jennifer; Etxeandia-Ikobaltzeta, Itziar; Humphrey, Linda L.
title: 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
date: 2020-07-30
journal: Ann Intern Med
DOI: 10.7326/l20-1007
sha: 2b99bb2704606834b66d0bc6eaf207a867f81975
doc_id: 930607
cord_uid: 3wrl3kf4

nan

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, inprogress 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) (4) (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 complete 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 A sixth newly published large cohort study was identified but not considered further because it was retracted due to concerns about the veracity of the data (17, 18) .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) (4) (5) and no data were available to assess from those RCTs.

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-19positive 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). Disclosures: Disclosures can be viewed at www.acponline.org /authors/icmje/ConflictOfInterestForms.do?msNum=L20-1007. 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.

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 (Version 1)

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

Accessed at www.recoverytrial.net/news/statement -from-the-chief-investigators-of-the-randomised-evaluation-of-covid-19 -therapy-recovery-trial-on-hydroxychloroquine-5-june-2020-no-clinical-benefitfrom-use-of-hydroxychloroquine-in-hospitalised-patients-with-covid-19 on 6

World Health Organization. WHO discontinues hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19

National Institutes of Health. NIH halts clinical trial of hydroxychloroquine: study shows treatment does no harm

Accessed at www.nih.gov/news-events/news-releases/nih-halts -clinical-trial-hydroxychloroquine on 6

COVID-19) update: FDA revokes emergency use authorization for chloroquine and hydroxychloroquine

Hydroxychloroquine or chloroquine for treatment or prophylaxis of COVID-19: A living systematic review

Update alert: hydroxychloroquine or chloroquine for the treatment or prophylaxis of COVID-19

Efficacy and safety of chloroquine or hydroxychloroquine in moderate type of COVID-19: a prospective open-label randomized controlled study. medRxiv. Preprint posted online 22

Hydroxychloroquine with or without azithromycin and in-hospital mortality or discharge in patients hospitalized for COVID-19 infection: a cohort study of 4,642 in-patients in France. medRxiv. Preprint posted online 19

Association of treatment with hydroxychloroquine or azithromycin with in-hospital mortality in patients with COVID-19 in new york state

Hydroxychloroquine and tocilizumab therapy in COVID-19 patients-an observational study. medRxiv. Preprint posted online 25

Outcomes of hydroxychloroquine treatment among hospitalized COVID-19 patients in the United States-realworld evidence from a federated electronic medical record Network. medRxiv. Preprint posted online 19

Treatment with hydroxychloroquine, azithromycin, and combination in patients hospitalized with COVID-19

Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial

Low dose of hydroxychloroquine reduces fatality of critically ill patients with COVID-19. Sci China Life Sci

Accessed at www.pharmacypracticenews.com/Covid-19/Article/05-20/2-Papers-About Drug-Therapy-in-COVID-19-Retracted

RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis