Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19.

Adult Antimalarials / administration & dosage Betacoronavirus COVID-19 Coronavirus Infections / drug therapy Dose-Response Relationship, Drug Hospitalization / trends Humans Hydroxychloroquine / administration & dosage Pandemics Pneumonia, Viral / drug therapy SARS-CoV-2 Single-Blind Method Treatment Outcome
ARDS COVID-19 ORCHID SARS-CoV-2 hydroxychloroquine

Journal

Annals of the American Thoracic Society
ISSN: 2325-6621
Titre abrégé: Ann Am Thorac Soc
Pays: United States
ID NLM: 101600811

Informations de publication

Date de publication:
09 2020
Historique:
pubmed: 4 6 2020
medline: 22 9 2020
entrez: 4 6 2020
Statut: ppublish

Résumé

The ORCHID (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with coronavirus disease (COVID-19). This document provides the rationale and background for the trial and highlights key design features. We discuss five novel challenges to the design and conduct of a large, multicenter, randomized trial during a pandemic, including

Identifiants

DOI: 10.1513/AnnalsATS.202005-478SD PMID: 32492354 PMC: PMC7462324
pubmed: 32492354
doi: 10.1513/AnnalsATS.202005-478SD
pmc: PMC7462324
doi:

Substances chimiques

Antimalarials 0
Hydroxychloroquine 4QWG6N8QKH

Banques de données

ClinicalTrials.gov
['NCT04332991']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

1144-1153

Subventions

Organisme : NHLBI NIH HHS
ID : K23 HL153584
Pays : United States
Organisme : NHLBI NIH HHS
ID : T32 HL087738
Pays : United States

Commentaires et corrections

Type : CommentIn

Références

J Bone Joint Surg Am. 2012 Jul 18;94 Suppl 1:56-60
pubmed: 22810449
N Engl J Med. 2020 May 7;382(19):1787-1799
pubmed: 32187464
JAMA. 2020 Apr 14;323(14):1339-1340
pubmed: 32108857
Cell Res. 2020 Mar;30(3):269-271
pubmed: 32020029
Clin Infect Dis. 2020 Apr 27;:
pubmed: 32338708
Ann Am Thorac Soc. 2017 Jan;14(1):124-133
pubmed: 27779896
Cell Discov. 2020 Mar 18;6:16
pubmed: 32194981
Ann Emerg Med. 2018 Oct;72(4):457-466
pubmed: 29753517
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
JAMA Netw Open. 2020 Apr 24;3(4):e208857
pubmed: 32330277
N Engl J Med. 2020 Mar 26;382(13):1268-1269
pubmed: 32109011
Am J Respir Crit Care Med. 2020 Jun 15;201(12):1560-1564
pubmed: 32348678
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
Lancet Infect Dis. 2003 Nov;3(11):722-7
pubmed: 14592603
JAMA. 2020 May 19;323(19):1899-1900
pubmed: 32297900
Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):215-219
pubmed: 32391667
Circulation. 2020 Jun 16;141(24):e906-e907
pubmed: 32267732
Clin Infect Dis. 2020 Jul 28;71(15):732-739
pubmed: 32150618
N Engl J Med. 2020 Apr 30;382(18):1708-1720
pubmed: 32109013
Biosci Trends. 2020 Mar 16;14(1):72-73
pubmed: 32074550
Am J Respir Cell Mol Biol. 2020 Jul;63(1):132-133
pubmed: 32315548
Control Clin Trials. 1989 Dec;10(4 Suppl):209S-221S
pubmed: 2605969
Ann Am Thorac Soc. 2020 Jul;17(7):787-789
pubmed: 32320268
JAMA. 2020 May 19;323(19):1897-1898
pubmed: 32208486
Nat Rev Rheumatol. 2020 Mar;16(3):155-166
pubmed: 32034323
Intensive Care Med. 2020 May;46(5):930-942
pubmed: 32072303
Antimicrob Agents Chemother. 2009 Apr;53(4):1468-75
pubmed: 19188392
Med Mal Infect. 2020 Jun;50(4):384
pubmed: 32240719
Lancet. 2020 Feb 15;395(10223):497-506
pubmed: 31986264
N Engl J Med. 2019 Dec 26;381(26):2529-2540
pubmed: 31826336
N Engl J Med. 2020 Jun 18;382(25):2411-2418
pubmed: 32379955
Int J Antimicrob Agents. 2020 Apr;55(4):105932
pubmed: 32145363
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
Crit Care Med. 2020 Jun;48(6):e440-e469
pubmed: 32224769
Am J Respir Crit Care Med. 2020 Jun 1;201(11):1324-1325
pubmed: 32311297
Int J Antimicrob Agents. 2020 Jun;55(6):105982
pubmed: 32305588
Clin Infect Dis. 2018 Apr 17;66(9):1454-1457
pubmed: 29206908
JAMA. 2020 May 12;323(18):1824-1836
pubmed: 32282022
Expert Opin Drug Saf. 2017 Mar;16(3):411-419
pubmed: 27927040
Pharmacol Res Perspect. 2017 Jan 23;5(1):e00293
pubmed: 28596841
Int J Antimicrob Agents. 2020 Jul;56(1):105949
pubmed: 32205204
Philos Trans R Soc Lond B Biol Sci. 2017 May 26;372(1721):
pubmed: 28396467

Auteurs

Jonathan D Casey (JD)

Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine.
ORCID: 0000-0002-0977-290X

Nicholas J Johnson (NJ)

Department of Emergency Medicine.
Division of Pulmonary, Critical Care, and Sleep Medicine, Harborview Medical Center, and.
ORCID: 0000-0001-9915-0591

Matthew W Semler (MW)

Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine.
ORCID: 0000-0002-7664-8263

Sean P Collins (SP)

Department of Emergency Medicine, and.

Neil R Aggarwal (NR)

Division of Lung Diseases, National Heart, Lung and Blood Institute, Bethesda, Maryland.

Roy G Brower (RG)

Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.

Steven Y Chang (SY)

Division of Pulmonary and Critical Care Medicine, Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, California.

John Eppensteiner (J)

Department of Surgery, Duke University, Durham, North Carolina.

Michael Filbin (M)

Department of Emergency Medicine.

Kevin W Gibbs (KW)

Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.

Adit A Ginde (AA)

Department of Emergency Medicine and.

Michelle N Gong (MN)

Division of Epidemiology and Population Health, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, New York City, New York.

Frank Harrell (F)

Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.

Douglas L Hayden (DL)

Department of Medicine, and.

Catherine L Hough (CL)

Division of Pulmonary, Critical Care, and Sleep Medicine, Harborview Medical Center, and.

Akram Khan (A)

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland, Oregon.

Lindsay M Leither (LM)

Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah.

Marc Moss (M)

Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, Colorado.

Cathryn F Oldmixon (CF)

Department of Medicine, and.

Pauline K Park (PK)

Department of Surgery, University of Michigan, Ann Arbor, Michigan.

Lora A Reineck (LA)

Division of Lung Diseases, National Heart, Lung and Blood Institute, Bethesda, Maryland.

Nancy J Ringwood (NJ)

Department of Medicine, and.

Bryce R H Robinson (BRH)

Department of Surgery, University of Washington, Seattle, Washington.

David A Schoenfeld (DA)

Department of Medicine, and.

Nathan I Shapiro (NI)

Department of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.

Jay S Steingrub (JS)

Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, Massachusetts.

Donna K Torr (DK)

Department of Pharmacy Services, Vanderbilt University Medical Center, Nashville, Tennessee; and.

Alexandra Weissman (A)

Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.

Christopher J Lindsell (CJ)

Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.

Todd W Rice (TW)

Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine.

B Taylor Thompson (BT)

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.

Samuel M Brown (SM)

Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah.
ORCID: 0000-0003-1206-6261

Wesley H Self (WH)

Department of Emergency Medicine, and.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female

Evaluation of Low-Value Services Across Major Medicare Advantage Insurers and Traditional Medicare.

Ciara Duggan, Adam L Beckman, Ishani Ganguli et al.
1.00
Humans United States Aged Cross-Sectional Studies Medicare Part C

Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

Hallie Tankha, Devyn Gaskins, Amanda Shallcross et al.
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Anti-infectieux › Antiparasitaires › Antiprotozoaires › Antipaludiques › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Virus › Virus à ARN › Virus à ARN à brin positif › Nidovirales › Coronaviridae › Coronavirus › Betacoronavirus › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie virale › COVID-19 › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Infection › Maladies virales › Infections à virus à ARN › Infections à Nidovirales › Infections à Coronaviridae › Infections à coronavirus › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Phénomènes physiologiques › Phénomènes pharmacologiques et toxicologiques › Phénomènes toxicologiques › Relation dose-effet des médicaments › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Services de santé › Soins aux patients › Hospitalisation › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Composés hétérocycliques › Composés hétérocycliques à cycles fusionnés › Composés hétérobicycliques › Quinoléines › Aminoquinoléines › Chloroquine › Hydroxychloroquine › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Épidémies de maladies › Épidémies › Pandémies › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie virale › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Virus › Virus à ARN › Virus à ARN à brin positif › Nidovirales › Coronaviridae › Coronavirus › Betacoronavirus › Virus du SRAS › SARS-CoV-2 › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en simple aveugle › Rationale and Design of ORCHID: A Randomized...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Rationale and Design of ORCHID: A Randomized...