Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support among Critically Ill Patients with COVID-19: A Randomized Clinical Trial

JAMA - Journal of the American Medical Association

Volumn 324, Issue 13, 2020, Pages 1298-1306

  Dequin, Pierre François ^a,b   Heming, Nicholas ^c,d,p   Meziani, Ferhat ^e,f   Plantefève, Gaëtan ^g   Voiriot, Guillaume ^h,i   Badié, Julio ^j   François, Bruno ^k,l   Aubron, Cécile ^m,n   Ricard, Jean Damien ^o   Ehrmann, Stephan ^a,b   Jouan, Youenn ^a,b   Guillon, Antoine ^a,b   Leclerc, Marie ^a   Coffre, Carine ^a   Bourgoin, Hélène ^a   Lengellé, Céline ^a   Caille Fénérol, Caroline ^k   Tavernier, Elsa ^a   Zohar, Sarah ⁱ   Giraudeau, Bruno ^a,b   Annane, Djillali ^c,d   Le Gouge, Amélie ^a   more..

^a UNIVERSITY HOSPITAL OF TOURS   (France)

^b UNIVERSITÉ DE TOURS   (France)

^c RAYMOND POINCARÉ HOSPITAL   (France)

^d LABORATOIRE DES SCIENCES DU CLIMAT ET DE L ENVIRONNEMENT   (France)

^e HÔPITAL CIVIL   (France)

^f UNIVERSITÉ DE STRASBOURG   (France)

^g CH Victor Dupouy   (France)

^h ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

ⁱ SORBONNE UNIVERSITÉ   (France)

^j Nord Franche Comté Hospital   (France)

^k LIMOGES UNIVERSITY HOSPITAL   (France)

^l UMR 1092   (France)

^m BREST UNIVERSITY HOSPITAL   (France)

ⁿ UNIVERSITÉ DE BRETAGNE OCCIDENTALE   (France)

^o HÔPITAL LOUIS MOURIER   (France)

^p Université de Paris ^*

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; AZITHROMYCIN; ECULIZUMAB; HYDROCORTISONE; HYDROXYCHLOROQUINE; LOPINAVIR PLUS RITONAVIR; NITRIC OXIDE; OXYGEN; PLACEBO; REMDESIVIR; TOCILIZUMAB; ANTIINFLAMMATORY AGENT;

ABDOMINAL BLEEDING; ACUTE RESPIRATORY FAILURE; ADULT; AGED; ARTICLE; ARTIFICIAL VENTILATION; ASSISTED VENTILATION; BLOOD OXYGEN TENSION; CLINICAL OUTCOME; CONTROLLED STUDY; CORONAVIRUS DISEASE 2019; CRITICALLY ILL PATIENT; DISEASE ASSOCIATION; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFECT; ENDOTRACHEAL INTUBATION; EXTRACORPOREAL OXYGENATION; FEMALE; FOLLOW UP; FRANCE; HOSPITAL ADMISSION; HOSPITALIZATION; HUMAN; HUMAN CELL; INCIDENCE; INTENSIVE CARE UNIT; LOW DRUG DOSE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; OXYGEN THERAPY; PATIENT CARE; PATIENT MONITORING; PRIORITY JOURNAL; PRONE POSITION; RANDOMIZED CONTROLLED TRIAL; SECONDARY INFECTION; SEQUENTIAL ANALYSIS; SURVIVAL TIME; BETACORONAVIRUS; CLINICAL TRIAL; CORONAVIRUS INFECTION; CRITICAL ILLNESS; EARLY TERMINATION OF CLINICAL TRIAL; MIDDLE AGED; PANDEMIC; RESPIRATORY FAILURE; TREATMENT FAILURE; VIRUS PNEUMONIA;

AGED; ANTI-INFLAMMATORY AGENTS; BETACORONAVIRUS; CORONAVIRUS INFECTIONS; CRITICAL ILLNESS; DOUBLE-BLIND METHOD; EARLY TERMINATION OF CLINICAL TRIALS; FEMALE; HUMANS; HYDROCORTISONE; MALE; MIDDLE AGED; OXYGEN INHALATION THERAPY; PANDEMICS; PNEUMONIA, VIRAL; RESPIRATION, ARTIFICIAL; RESPIRATORY INSUFFICIENCY; TREATMENT FAILURE;

EID: 85090922137     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2020.16761     Document Type: Article

References (30)

1. COVID-19 dashboard. Johns Hopkins Center for Systems Science and Engineering. Accessed August 17, 2020. https://coronavirus.jhu.edu/map.html
2. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020; 323 (13): 1239-1242. doi: 10.1001/jama.2020.2648 32091533
3. Grasselli G, Zangrillo A, Zanella A,; COVID-19 Lombardy ICU Network. Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020; 323 (16): 1574-1581. doi: 10.1001/jama.2020.5394 32250385
4. Beigel JH, Tomashek KM, Dodd LE,; ACTT-1 Study Group Members. Remdesivir for the treatment of Covid-19-preliminary report. N Engl J Med. Published online May 22, 2020. doi: 10.1056/NEJMoa2007764 32445440
5. Huang C, Wang Y, Li X, Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020; 395 (10223): 497-506. doi: 10.1016/S0140-6736(20)30183-5 31986264
6. Moore JB, June CH. Cytokine release syndrome in severe COVID-19. Science. 2020; 368 (6490): 473-474. doi: 10.1126/science.abb8925 32303591
7. Sinha P, Matthay MA, Calfee CS. Is a "cytokine storm" relevant to COVID-19? JAMA Intern Med. Published online June 30, 2020. doi: 10.1001/jamainternmed.2020.3313 32602883
8. Guillon A, Hiemstra PS, Si-Tahar M. Pulmonary immune responses against SARS-CoV-2 infection: harmful or not? Intensive Care Med. Published online July 17, 2020. doi: 10.1007/s00134-020-06170-8 32681297
9. Jouan Y, Guillon A, Gonzalez L, Functional alteration of innate T cells in critically ill patients with COVID-19. J Exp Med. Published online May 6, 2020. Accessed August 18, 2020. https://www.medrxiv.org/content/10.1101/2020.05.03.20089300v1.full.pdf
10. Sanders JM, Monogue ML, Jodlowski TZ, Cutrell JB. Pharmacologic treatments for coronavirus disease (COVID-19): a review. JAMA. 2020; 323 (18): 1824-1836. doi: 10.1001/jama.2020.6019 32282022
11. Arabi YM, Fowler R, Hayden FG. Critical care management of adults with community-acquired severe respiratory viral infection. Intensive Care Med. 2020; 46 (2): 315-328. doi: 10.1007/s00134-020-05943-5 32040667
12. Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020; 395 (10223): 473-475. doi: 10.1016/S0140-6736(20)30317-2 32043983
13. Moreno G, Rodríguez A, Reyes LF,; GETGAG Study Group. Corticosteroid treatment in critically ill patients with severe influenza pneumonia: a propensity score matching study. Intensive Care Med. 2018; 44 (9): 1470-1482. doi: 10.1007/s00134-018-5332-4 30074052
14. Wu C, Chen X, Cai Y, Risk factors associated with acute respiratory distress syndrome and death in patients with coronavirus disease 2019 pneumonia in Wuhan, China. JAMA Intern Med. 2020; 180 (7): 1-11. doi: 10.1001/jamainternmed.2020.0994 32167524
15. RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with COVID-19: preliminary report. N Engl J Med. Published online July 17, 2020. doi: 10.1056/NEJMoa2021436.
16. Dequin PF, Le Gouge A, Tavernier E, Giraudeau B, Zohar S. Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience. Stat Biopharmaceut Res. Published online July 23, 2020. doi: 10.1080/19466315.2020.1800509.
17. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika. 1983; 70: 659-663. doi: 10.2307/2336502.
18. Fine MJ, Auble TE, Yealy DM, A prediction rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med. 1997; 336 (4): 243-250. doi: 10.1056/NEJM199701233360402 8995086
19. Vincent JL, Moreno R, Takala J,; Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. Intensive Care Med. 1996; 22 (7): 707-710. doi: 10.1007/BF01709751 8844239
20. Papazian L, Aubron C, Brochard L, Formal guidelines: management of acute respiratory distress syndrome. Ann Intensive Care. 2019; 9 (1): 69. doi: 10.1186/s13613-019-0540-9 31197492
21. Torres A, Sibila O, Ferrer M, Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial. JAMA. 2015; 313 (7): 677-686. doi: 10.1001/jama.2015.88 25688779
22. Fine JP, Gray RJ. A proportional hazards model for the sub-distribution of a competing risk. JASA 1999; 94 (446): 496-509. doi: 10.1080/01621459.1999.10474144
23. Sterne JAC, Diaz J, Villar J,; WHO COVID-19 Management and Characterization Working Group. Corticosteroid therapy for critically ill patients with COVID-19: a structured summary of a study protocol for a prospective meta-analysis of randomized trials. Trials. 2020; 21 (1): 734. doi: 10.1186/s13063-020-04641-3. 32831155
24. Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993; 270 (24): 2957-2963. doi: 10.1001/jama.1993.03510240069035 8254858
25. Blum CA, Nigro N, Briel M, Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2015; 385 (9977): 1511-1518. doi: 10.1016/S0140-6736(14)62447-8 25608756
26. Siemieniuk RAC, Meade MO, Alonso-Coello P, Corticosteroid therapy for patients hospitalized with community-acquired pneumonia: a systematic review and meta-analysis. Ann Intern Med. 2015; 163 (7): 519-528. doi: 10.7326/M15-0715 26258555
27. Stockman LJ, Bellamy R, Garner P. SARS: systematic review of treatment effects. PLoS Med. 2006; 3 (9): e343. doi: 10.1371/journal.pmed.0030343 16968120
28. Arabi YM, Mandourah Y, Al-Hameed F,; Saudi Critical Care Trial Group. Corticosteroid therapy for critically ill patients with Middle East Respiratory Syndrome. Am J Respir Crit Care Med. 2018; 197 (6): 757-767. doi: 10.1164/rccm.201706-1172OC 29161116
29. Lee N, Allen Chan KC, Hui DS, Effects of early corticosteroid treatment on plasma SARS-associated coronavirus RNA concentrations in adult patients. J Clin Virol. 2004; 31 (4): 304-309. doi: 10.1016/j.jcv.2004.07.006 15494274
30. Yang Z, Liu J, Zhou Y, Zhao X, Zhao Q, Liu J. The effect of corticosteroid treatment on patients with coronavirus infection: a systematic review and meta-analysis. J Infect. 2020; 81 (1): e13-e20. doi: 10.1016/j.jinf.2020.03.062 32283144