Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19: a randomised double-blinded placebo-controlled trial.
Journal
The European respiratory journal
ISSN: 1399-3003
Titre abrégé: Eur Respir J
Pays: England
ID NLM: 8803460
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
received:
15
03
2021
accepted:
22
05
2021
pubmed:
5
6
2021
medline:
12
1
2022
entrez:
4
6
2021
Statut:
epublish
Résumé
Combining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having Placebo-controlled double-blind randomised multicentre trial. Patients aged ≥18 years, admitted to hospital for ≤48 h (not intensive care) with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription PCR test were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice-daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14). After randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on 1 February 2021. 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median (interquartile range) 9.0 (3-11) DAOH14 The combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.
Sections du résumé
BACKGROUND
Combining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having
METHODS
Placebo-controlled double-blind randomised multicentre trial. Patients aged ≥18 years, admitted to hospital for ≤48 h (not intensive care) with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription PCR test were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice-daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).
RESULTS
After randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on 1 February 2021. 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median (interquartile range) 9.0 (3-11) DAOH14
CONCLUSIONS
The combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.
Identifiants
pubmed: 34083403
pii: 13993003.00752-2021
doi: 10.1183/13993003.00752-2021
pmc: PMC8186006
pii:
doi:
Substances chimiques
Hydroxychloroquine
4QWG6N8QKH
Azithromycin
83905-01-5
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright ©The authors 2022.
Déclaration de conflit d'intérêts
Conflict of interest: P. Sivapalan reports fees from Boehringer Ingelheim, outside the submitted work. C.S. Ulrik reports fees from Boehringer Ingelheim, AZ, GSK, TEVA, Novartis, ALK-Abello, Mundipharma, Sanofi Genzyme, Orion Pharma and Actelion, outside the submitted work. K.E.J. Håkansson reports personal fees from AstraZeneca, Chiesi and TEVA, outside the submitted work. T. Biering-Sørensen has received research grants from GE Healthcare and Sanofi Pasteur, as well as personal fees from Sanofi Pasteur, Novartis and Amgen, outside the submitted work. None of the other authors have any conflicts of interest.
Références
Eur Respir J. 2021 Apr 15;57(4):
pubmed: 33692120
Circulation. 2020 Jun 16;141(24):e906-e907
pubmed: 32267732
JAMA. 2020 Dec 1;324(21):2165-2176
pubmed: 33165621
Trials. 2020 Jun 10;21(1):513
pubmed: 32522282
Am Heart J. 2011 Nov;162(5):900-6
pubmed: 22093207
Nat Rev Nephrol. 2011 Oct 18;7(12):718-29
pubmed: 22009248
Drugs. 2020 Dec;80(18):1929-1946
pubmed: 33068263
JAMA Netw Open. 2020 Apr 24;3(4):e208857
pubmed: 32330277
F1000Res. 2021 Feb 4;10:73
pubmed: 33763201
Lancet. 2020 May 22;:
pubmed: 32450107
Virol J. 2005 Aug 22;2:69
pubmed: 16115318
N Engl J Med. 2011 Aug 25;365(8):689-98
pubmed: 21864166
JAMA Cardiol. 2020 Sep 1;5(9):1036-1041
pubmed: 32936252
N Engl J Med. 2021 Feb 25;384(8):693-704
pubmed: 32678530
Trials. 2020 Oct 20;21(1):867
pubmed: 33081817
Eur Respir J. 2019 Nov 28;54(5):
pubmed: 31515407
Int J Antimicrob Agents. 2020 May;55(5):105960
pubmed: 32251731
Cochrane Database Syst Rev. 2014 Sep 01;(9):CD001288
pubmed: 25178099
N Engl J Med. 2020 Nov 19;383(21):2030-2040
pubmed: 33031652
JAMA. 2013 Mar 27;309(12):1251-9
pubmed: 23532241
JAMA. 2020 Nov 17;324(19):1948-1956
pubmed: 33201202
JAMA. 2013 Nov 27;310(20):2191-4
pubmed: 24141714
Lancet. 2017 Aug 12;390(10095):659-668
pubmed: 28687413
Lancet Respir Med. 2019 Aug;7(8):699-709
pubmed: 31122894
Int J Antimicrob Agents. 2020 Aug;56(2):106020
pubmed: 32405156
Int J Antimicrob Agents. 2018 Jun;51(6):918-924
pubmed: 29501821
N Engl J Med. 2021 Mar 11;384(10):905-914
pubmed: 33356051
Biometrics. 1979 Sep;35(3):549-56
pubmed: 497341
Lancet. 2021 Feb 13;397(10274):605-612
pubmed: 33545096
Lancet Respir Med. 2019 Oct;7(10):845-854
pubmed: 31405828
N Engl J Med. 2020 Nov 5;383(19):1813-1826
pubmed: 32445440
N Engl J Med. 2020 Nov 19;383(21):2041-2052
pubmed: 32706953
Lancet Infect Dis. 2003 Nov;3(11):722-7
pubmed: 14592603