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Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.
Sivapalan, Pradeesh; Ulrik, Charlotte Suppli; Lappere, Therese Sophie; Eklöf, Josefin Viktoria; Shaker, Saher Burhan; Bødtger, Uffe Christian Steinholtz; Browatzki, Andrea; Meyer, Christian Niels; Weinreich, Ulla Møller; Laursen, Christian B; Biering-Sørensen, Tor; Knop, Filip Krag; Lundgren, Jens D; Jensen, Jens-Ulrik Stæhr.
  • Sivapalan P; Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. Pradeesh.s@dadlnet.dk.
  • Ulrik CS; Amager and Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
  • Lappere TS; Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
  • Eklöf JV; Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
  • Shaker SB; Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
  • Bødtger UCS; Næstved, Slagelse and Ringsted Hospitals, University of Southern Denmark, Odense, Denmark.
  • Browatzki A; Nordsjællands Hospital Hillerød, University of Copenhagen, Hillerød, Denmark.
  • Meyer CN; Zeeland University Hospital, Roskilde, Denmark.
  • Weinreich UM; Aalborg University Hospital, Aalborg University, Aalborg, Denmark.
  • Laursen CB; Odense University Hospital, University of Southern Denmark, Odense, Denmark.
  • Biering-Sørensen T; Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
  • Knop FK; Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
  • Lundgren JD; Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
  • Jensen JS; Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
Trials ; 21(1): 867, 2020 Oct 20.
Article in English | MEDLINE | ID: covidwho-883594
ABSTRACT

BACKGROUND:

There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease.

METHODS:

The ProPAC-COVID is a multi-center, randomized, placebo-controlled, double-blinded clinical trial. The primary outcome is number of days spent alive and out of hospital within 14 days from randomization. Randomization will be in blocks of unknown size, and the final allocation will be stratified for age, site of recruitment, and whether the patient has any chronic lung diseases. Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis.

DISCUSSION:

This paper describes the detailed statistical analysis plan for the evaluation of primary and secondary endpoints of the ProPAC-COVID study. Enrolment of patients to the ProPAC-COVID study is still ongoing. The purpose of this paper is to provide primary publication of study results to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency. TRIAL REGISTRATION ClinicalTrials.gov NCT04322396 . Registered on 26 March 2020.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Azithromycin / Pandemics / Betacoronavirus / Hydroxychloroquine / Anti-Bacterial Agents / Antimalarials Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Male Country/Region as subject: Europa Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2020 Document Type: Article Affiliation country: S13063-020-04795-0

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Azithromycin / Pandemics / Betacoronavirus / Hydroxychloroquine / Anti-Bacterial Agents / Antimalarials Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Male Country/Region as subject: Europa Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2020 Document Type: Article Affiliation country: S13063-020-04795-0