Dataset Information

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.

SUBMITTER: Sivapalan P

PROVIDER: S-EPMC8186006 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Sivapalan Pradeesh P Ulrik Charlotte Suppli CS Lapperre Therese Sophie TS Bojesen Rasmus Dahlin RD Eklöf Josefin J Browatzki Andrea A Wilcke Jon Torgny JT Gottlieb Vibeke V Håkansson Kjell Erik Julius KEJ Tidemandsen Casper C Tupper Oliver O Meteran Howraman H Bergsøe Christina C Brøndum Eva E Bødtger Uffe U Bech Rasmussen Daniel D Graff Jensen Sidse S Pedersen Lars L Jordan Alexander A Priemé Helene H Søborg Christian C Steffensen Ida E IE Høgsberg Dorthe D Klausen Tobias Wirenfeldt TW Frydland Martin Steen MS Lange Peter P Sverrild Asger A Ghanizada Muhzda M Knop Filip K FK Biering-Sørensen Tor T Lundgren Jens D JD Jensen Jens-Ulrik Stæhr JS

The European respiratory journal 20220106 1

<h4>Background</h4>Combining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having <i>in vitro</i> antiviral properties. This may improve outcomes in patients hospitalised for coronavirus disease 2019 (COVID-19).<h4>Methods</h4>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 (SA ...[more]

PMID: 34083403

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Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

Similar Datasets

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