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Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19: a randomised double-blinded placebo-controlled trial

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Harvard

Sivapalan, P, Ulrik, CS, Lapperre, TS, Bojesen, RD, Eklöf, J, Browatzki, A, Wilcke, JT, Gottlieb, V, Håkansson, KEJ, Tidemandsen, C, Tupper, O, Meteran, H, Bergsøe, C, Brøndum, E, Bødtger, U, Bech Rasmussen, D, Graff Jensen, S, Pedersen, L, Jordan, A, Priemé, H, Søborg, C, Steffensen, IE, Høgsberg, D, Klausen, TW, Frydland, MS, Lange, P, Sverrild, A, Ghanizada, M, Knop, FK, Biering-Sørensen, T, Lundgren, JD, Jensen, J-US & ProPAC-COVID writing group on behalf of the ProPAC-COVID Study Group 2022, 'Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19: a randomised double-blinded placebo-controlled trial', The European respiratory journal, bind 59, nr. 1, 2100752, s. 1-12. https://doi.org/10.1183/13993003.00752-2021

APA

Sivapalan, P., Ulrik, C. S., Lapperre, T. S., Bojesen, R. D., Eklöf, J., Browatzki, A., Wilcke, J. T., Gottlieb, V., Håkansson, K. E. J., Tidemandsen, C., Tupper, O., Meteran, H., Bergsøe, C., Brøndum, E., Bødtger, U., Bech Rasmussen, D., Graff Jensen, S., Pedersen, L., Jordan, A., ... ProPAC-COVID writing group on behalf of the ProPAC-COVID Study Group (2022). Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19: a randomised double-blinded placebo-controlled trial. The European respiratory journal, 59(1), 1-12. [2100752]. https://doi.org/10.1183/13993003.00752-2021

CBE

Sivapalan P, Ulrik CS, Lapperre TS, Bojesen RD, Eklöf J, Browatzki A, Wilcke JT, Gottlieb V, Håkansson KEJ, Tidemandsen C, Tupper O, Meteran H, Bergsøe C, Brøndum E, Bødtger U, Bech Rasmussen D, Graff Jensen S, Pedersen L, Jordan A, Priemé H, Søborg C, Steffensen IE, Høgsberg D, Klausen TW, Frydland MS, Lange P, Sverrild A, Ghanizada M, Knop FK, Biering-Sørensen T, Lundgren JD, Jensen J-US, ProPAC-COVID writing group on behalf of the ProPAC-COVID Study Group. 2022. Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19: a randomised double-blinded placebo-controlled trial. The European respiratory journal. 59(1):1-12. https://doi.org/10.1183/13993003.00752-2021

MLA

Vancouver

Author

Sivapalan, Pradeesh ; Ulrik, Charlotte Suppli ; Lapperre, Therese Sophie ; Bojesen, Rasmus Dahlin ; Eklöf, Josefin ; Browatzki, Andrea ; Wilcke, Jon Torgny ; Gottlieb, Vibeke ; Håkansson, Kjell Erik Julius ; Tidemandsen, Casper ; Tupper, Oliver ; Meteran, Howraman ; Bergsøe, Christina ; Brøndum, Eva ; Bødtger, Uffe ; Bech Rasmussen, Daniel ; Graff Jensen, Sidse ; Pedersen, Lars ; Jordan, Alexander ; Priemé, Helene ; Søborg, Christian ; Steffensen, Ida E ; Høgsberg, Dorthe ; Klausen, Tobias Wirenfeldt ; Frydland, Martin Steen ; Lange, Peter ; Sverrild, Asger ; Ghanizada, Muhzda ; Knop, Filip K ; Biering-Sørensen, Tor ; Lundgren, Jens D ; Jensen, Jens-Ulrik Stæhr ; ProPAC-COVID writing group on behalf of the ProPAC-COVID Study Group. / Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19 : a randomised double-blinded placebo-controlled trial. I: The European respiratory journal. 2022 ; Bind 59, Nr. 1. s. 1-12.

Bibtex

@article{7a7c1faead5143ebb2ec7d59f6473b4a,
title = "Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19: a randomised double-blinded placebo-controlled trial",
abstract = "BACKGROUND: Combining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for coronavirus disease 2019 (COVID-19).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 versus 9.0 (7-10) DAOH14 in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for one patient in the intervention group versus two patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for nine patients in the intervention group versus six patients receiving placebo (p=0.57).CONCLUSIONS: The combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.",
keywords = "Adolescent, Adult, Azithromycin, COVID-19/drug therapy, Double-Blind Method, Humans, Hydroxychloroquine, SARS-CoV-2, Treatment Outcome",
author = "Pradeesh Sivapalan and Ulrik, {Charlotte Suppli} and Lapperre, {Therese Sophie} and Bojesen, {Rasmus Dahlin} and Josefin Ekl{\"o}f and Andrea Browatzki and Wilcke, {Jon Torgny} and Vibeke Gottlieb and H{\aa}kansson, {Kjell Erik Julius} and Casper Tidemandsen and Oliver Tupper and Howraman Meteran and Christina Bergs{\o}e and Eva Br{\o}ndum and Uffe B{\o}dtger and {Bech Rasmussen}, Daniel and {Graff Jensen}, Sidse and Lars Pedersen and Alexander Jordan and Helene Priem{\'e} and Christian S{\o}borg and Steffensen, {Ida E} and Dorthe H{\o}gsberg and Klausen, {Tobias Wirenfeldt} and Frydland, {Martin Steen} and Peter Lange and Asger Sverrild and Muhzda Ghanizada and Knop, {Filip K} and Tor Biering-S{\o}rensen and Lundgren, {Jens D} and Jensen, {Jens-Ulrik St{\ae}hr} and {ProPAC-COVID writing group on behalf of the ProPAC-COVID Study Group}",
note = "Copyright {\textcopyright}The authors 2022.",
year = "2022",
month = jan,
doi = "10.1183/13993003.00752-2021",
language = "English",
volume = "59",
pages = "1--12",
journal = "European Respiratory Journal",
issn = "0903-1936",
publisher = "European Respiratory Society",
number = "1",

}

RIS

TY - JOUR

T1 - Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19

T2 - a randomised double-blinded placebo-controlled trial

AU - Sivapalan, Pradeesh

AU - Ulrik, Charlotte Suppli

AU - Lapperre, Therese Sophie

AU - Bojesen, Rasmus Dahlin

AU - Eklöf, Josefin

AU - Browatzki, Andrea

AU - Wilcke, Jon Torgny

AU - Gottlieb, Vibeke

AU - Håkansson, Kjell Erik Julius

AU - Tidemandsen, Casper

AU - Tupper, Oliver

AU - Meteran, Howraman

AU - Bergsøe, Christina

AU - Brøndum, Eva

AU - Bødtger, Uffe

AU - Bech Rasmussen, Daniel

AU - Graff Jensen, Sidse

AU - Pedersen, Lars

AU - Jordan, Alexander

AU - Priemé, Helene

AU - Søborg, Christian

AU - Steffensen, Ida E

AU - Høgsberg, Dorthe

AU - Klausen, Tobias Wirenfeldt

AU - Frydland, Martin Steen

AU - Lange, Peter

AU - Sverrild, Asger

AU - Ghanizada, Muhzda

AU - Knop, Filip K

AU - Biering-Sørensen, Tor

AU - Lundgren, Jens D

AU - Jensen, Jens-Ulrik Stæhr

AU - ProPAC-COVID writing group on behalf of the ProPAC-COVID Study Group

N1 - Copyright ©The authors 2022.

PY - 2022/1

Y1 - 2022/1

N2 - BACKGROUND: Combining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for coronavirus disease 2019 (COVID-19).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 versus 9.0 (7-10) DAOH14 in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for one patient in the intervention group versus two patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for nine patients in the intervention group versus six patients receiving placebo (p=0.57).CONCLUSIONS: The combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

AB - BACKGROUND: Combining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for coronavirus disease 2019 (COVID-19).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 versus 9.0 (7-10) DAOH14 in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for one patient in the intervention group versus two patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for nine patients in the intervention group versus six patients receiving placebo (p=0.57).CONCLUSIONS: The combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

KW - Adolescent

KW - Adult

KW - Azithromycin

KW - COVID-19/drug therapy

KW - Double-Blind Method

KW - Humans

KW - Hydroxychloroquine

KW - SARS-CoV-2

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85123390021&partnerID=8YFLogxK

U2 - 10.1183/13993003.00752-2021

DO - 10.1183/13993003.00752-2021

M3 - Journal article

C2 - 34083403

VL - 59

SP - 1

EP - 12

JO - European Respiratory Journal

JF - European Respiratory Journal

SN - 0903-1936

IS - 1

M1 - 2100752

ER -

ID: 70609507