COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001435-27/FR

CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC - REC

patrick.cassai@chu-bordeaux.fr

2020-04-01

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

‒ Positive SARS-CoV-2 test on nasopharyngeal swab ‒ Onset of symptoms < 5 days prior to nasopharyngeal swabbing ‒ Age ≥ 60 years old ‒ Valid, ambulatory person, fully capable of understanding the challenges of the trial ‒ No hospitalization criteria according to current recommendations ‒ Signed informed consent ‒ Covered by Health Insurance ‒ Test SARS-CoV-2 positif sur prélèvement nasopharyngé ‒ Apparition des symptômes < 5 jours avant la réalisation du prélèvement nasopharyngé ‒ Âge ≥ 60 ans ‒ Personne valide, ambulatoire, en pleine capacité de comprendre les enjeux de l'essai ‒ Pas de critères d'hospitalisation selon les recommandations en cours ‒ Consentement éclairé signé ‒ Affilié(e) ou bénéficiaire d’un régime de la Sécurité Sociale

‒ Inability to make a decision to participate (dementia, guardianship) ‒ Long QT syndrome, or QTc space > 500 ms ‒ Heart rate <50 / min ‒ Hyperkalemia > 5.5 mmol/L or hypokalemia < 3.5 mmol/L ‒ Treatment with dasatinib, nilotinib, ibrutinib, , potent inhibitors of cytochrome P450 CYP3A4 isoenzyme, potent inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin. ‒ Hypersensitivity to any of the trial drugs, , ARA2 or sartan. ‒ Liver failure (stage ≥ Child-Pugh B), stage 4 or 5 chronic kidney disease (DFG <30 mL/min/1.73 m²), person on dialysis, malabsorption syndrome, symptomatic gout/hyperuricemia, ileus, colitis or enterocolitis, chronic infection with the hepatitis B virus. ‒ Incapacité à prendre une décision de participation (démence, tutelle) ‒ Syndrome du QT long connu, ou espace QTc > 500 ms ‒ Fréquence cardiaque <50/mn ‒ Hyperkaliémie >5,5 mmol/L ou hypokaliémie <3,5 mmol/L ‒ Traitement par dasatinib, nilotinib, ibrutinib, inhibiteurs puissants de l'isoenzyme CYP3A4 du cytochrome P450, inducteurs puissants de l'isoenzyme CYP3A4 du cytochrome P450, répaglinide, l’azathioprine, la 6-mercapto-purine, théophylline, pyrazinamide, warfarine. ‒ Hypersensibilité à l’un des médicaments de l'essai, aux ARA2 ou aux sartans. ‒ Insuffisance hépatique (stade ≥ Child-Pugh B), maladie rénale chronique stade 4 ou 5 (DFG <30 mL/min/1,73 m²), personne en dialyse, syndrome de malabsorption, goutte/hyperuricémie symptomatique, iléus, colite ou entérocolite, infection chronique par le virus de l'hépatite B.

5

CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC

65

None

France

Mild disease at enrollment

1: Mild disease at enrollment

845

Proportion of participants with an occurrence of hospitalization and/or death between D0 and D14 in each arm Proportion de participants avec une survenue d’'hospitalisation et/ou décès entre J0 et J14 dans chaque bras

Declared number of arm (5.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1274, "treatment_name": "Telmisartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]