학술논문
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
Document Type
article
Author
Pradeesh Sivapalan; Charlotte Suppli Ulrik; Rasmus Dahlin Bojesen; Therese Sophie Lapperre; Josefin Viktoria Eklöf; Kjell Erik Julius Håkansson; Andrea Browatzki; Casper Tidemansen; Jon Torgny Wilcke; Julie Janner; Vibeke Gottlieb; Howraman Meteran; Celeste Porsbjerg; Birgitte Lindegaard Madsen; Mia Moberg; Lars Pedersen; Thomas Lars Benfield; Jens Dilling Lundgren; Filip Krag Knop; Tor Biering-Sørensen; Muzhda Ghanizada; Tine Peick Sonne; Uffe Christian Steinholtz Bødtger; Sidse Graff Jensen; Daniel Bech Rasmussen; Eva Brøndum; Oliver Djurhuus Tupper; Susanne Wiemann Sørensen; Gitte Alstrup; Christian Borbjerg Laursen; Ulla Weinrich Møller; Asger Sverrild; Jens-Ulrik Stæhr Jensen
Source
Trials, Vol 21, Iss 1, Pp 1-4 (2020)
Subject
Language
English
ISSN
1745-6215
Abstract
Abstract Objectives 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. Trial design This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study. Participants 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. Inclusion criteria: • 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 menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR 480/470 ms). • Myasthenia gravis • Treatment with digoxin* • Glucose-6-phosphate dehydrogenase deficiency • Porphyria • Hypoglycaemia (Blood glucose at any time since hospitalization of 70 years vs.