Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19 (ProPAC-COVID)
Proactive Protection With Azithromycin and Hydroxychloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19
Aperçu de l'étude
Statut
Les conditions
Description détaillée
In the ongoing coronavirus pandemic, COVID-19, that arose in Wuhan China, there is still sparse data in the course, risk of various complications, and in particular how patients who are hospitalized are best treated to ensure high survival and short hospitalization. Despite the rapid spread of the disease globally, there is no solid data yet to recommend any specific treatments, which is why symptomatic, organ supportive therapy including respiratory therapy in acute pulmonary failure is recommended. There has been reported a high incidence of bacterial super-infections in patients with COVID-19. Patients with COVID-19 also have a higher risk of dying because of septic shock. Thus, there is an urgent need for treatment that can improve the patient's chance of the shortest hospitalization possible, and treatment that can lower the risk of secondary infection and death.
This is a randomized, placebo-controlled, double-blinded multi-center trial evaluating the effect of azithromycin and hydroxychloroquine treatment in patients with COVID-19 during hospitalization. The aim of the study is to investigate whether the treatment can shorten hospitalization, reduce the risk of non-invasive ventilation, admittance to Intensive Care Units and death.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
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Aalborg, Danemark
- Aalborg Sygehus
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Copenhagen, Danemark
- Bispebjerg Hospital
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Copenhagen, Danemark
- Hvidovre Hospital
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Copenhagen, Danemark
- Herlev-Gentofte Hospital
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Hillerød, Danemark
- Nordsjællands Hospital
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Odense, Danemark
- Odense Universitetshospital
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Roskilde, Danemark
- Roskilde Sygehus
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Slagelse, Danemark
- Slagelse Sygehus
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patient admitted to a Danish emergency department, lung medical department or medical department
- Age >18 years
- Hospitalized <48 hours
- Positive COVID-19 test/diagnosis during the hospitalization
- Signs informed consent
Exclusion Criteria:
- If the patient uses > 5 LO2/min at time of recruitment
- Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinolinderivates
- Pregnancy
- Breastfeeding
- Neurogenic hearing loss
- Psoriasis
- Retinopathy
- Maculopathy
- Changes in vision field
- Severe liver disease other than amoebiases
- Severe gastrointestinal, neurological or haematological disorders
- eGFR < 45 ml/min/1.73m2
- Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval
- Myasthenia Gravis
- Uses Digoxin
- Glucose-6-phosphate dehydrogenase deficiency
- Porphyria
- Hypoglycemia at any time since hospitalization
- Severe mental illness which significantly impedes cooperation
- Severe linguistic problems that significantly impedes cooperation
- Treatment with sickle alkaloids
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Control
This arm will receive standard care and placebo in 15 days. Azithromycin placebo: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 Hydroxychloroquine placebo: Day 1-15: 200 mg x 2 |
Placebo Azithromycin
Placebo Hydroxychloroquine
|
|
Comparateur actif: Intervention
This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 Hydroxychloroquine: Day 1-15: 200 mg x 2 |
Hydroxychloroquine
Azithromycine
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Number of Days Alive and Discharged From Hospital Within 14 Days
Délai: 14 days
|
14 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mortalité
Délai: 30 jours
|
30 jours
|
|
|
Mortalité
Délai: 90 jours
|
90 jours
|
|
|
Mortalité
Délai: 365 jours
|
365 jours
|
|
|
Categorization of Hospitalization Status
Délai: 14 days
|
The patient will be categorized into one of the following 8 categories depending on status of their hospitalization:
Only one category can be "yes". |
14 days
|
|
Length of Stay in ICU
Délai: 14 days
|
Length of stay in intensive care unit.
|
14 days
|
|
Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization
Délai: 14 days
|
14 days
|
|
|
Length of Hospitalization
Délai: 14 days
|
14 days
|
|
|
Days Alive and Discharged From Hospital
Délai: 30 days
|
30 days
|
|
|
Number of Readmissions (All Causes)
Délai: 30 days
|
30 days
|
|
|
Number of Days Using Non-invasive Ventilation (NIV)
Délai: 14 days
|
Number of days using non-invasive ventilation (NIV) if on NIV during hospitalization.
|
14 days
|
|
Change in Patient's Oxygen Partial Pressure
Délai: 4 days
|
PaO2 measured in arterial puncture at baseline and 4 days.
|
4 days
|
|
Change in Patient's Carbondioxide Partial Pressure
Délai: 4 days
|
PaCO2 measured in arterial puncture at baseline and 4 days.
|
4 days
|
|
Change of pH in Blood
Délai: 4 days
|
pH measured in arterial puncture at baseline and 4 days.
|
4 days
|
|
Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT")
Délai: 14 days
|
Time for no oxygen supplement (or regular oxygen supplement "LTOT") if on oxygen during admission.
|
14 days
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Sivapalan P, Ulrik CS, Lappere TS, Eklof JV, Shaker SB, Bodtger UCS, Browatzki A, Meyer CN, Weinreich UM, Laursen CB, Biering-Sorensen T, Knop FK, Lundgren JD, Jensen JS. Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan. Trials. 2020 Oct 20;21(1):867. doi: 10.1186/s13063-020-04795-0.
- Sivapalan P, Ulrik CS, Bojesen RD, Lapperre TS, Eklof JV, Hakansson KEJ, Browatzki A, Tidemansen C, Wilcke JT, Janner J, Gottlieb V, Meteran H, Porsbjerg C, Madsen BL, Moberg M, Pedersen L, Benfield TL, Lundgren JD, Knop FK, Biering-Sorensen T, Ghanizada M, Sonne TP, Bodtger UCS, Jensen SG, Rasmussen DB, Brondum E, Tupper OD, Sorensen SW, Alstrup G, Laursen CB, Moller UW, Sverrild A, Jensen JS. 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. 2020 Jun 10;21(1):513. doi: 10.1186/s13063-020-04409-9.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Infections à Coronaviridae
- Infections à Nidovirales
- Infections par virus à ARN
- Attributs de la maladie
- Infections à coronavirus
- Infections
- Maladies transmissibles
- Maladies virales
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Inhibiteurs d'enzymes
- Agents antirhumatismaux
- Agents antibactériens
- Agents antiprotozoaires
- Agents antiparasitaires
- Antipaludéens
- Azithromycine
- Hydroxychloroquine
Autres numéros d'identification d'étude
- KronLungesyg_COVID_19_protokol
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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