Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial

Trials
Pradeesh SivapalanJens-Ulrik Stæhr Jensen

Abstract

The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as "days alive and out of hospital" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death. This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study. 226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals. • Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years • Hospitalized ≤48 hours • Positive COVID-19 test / diagnosis during the hospitalization (confirmed). • Men or non-fertile women. Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menst...Continue Reading

Citations

Aug 28, 2020·Case Reports in Infectious Diseases·Elif Aksoy, Turgut Oztutgan
Jul 14, 2020·Frontiers in Immunology·Serena ColafrancescoRoberta Priori
Jun 5, 2021·The European Respiratory Journal·Pradeesh SivapalanUNKNOWN ProPAC-COVID writing group on behalf of the ProPAC-COVID Study Group
Jun 5, 2021·Journal of Pharmacy & Bioallied Sciences·Pathiyil Ravi ShankarShabaz Mohiuddin Gulam

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