COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001363-85/DK

Odense University Hospital - Clinical Trial Information

Not reported

2020-04-17

Terminated

RCT

Randomized

Parallel

Open label

single-center

Prevention

- Nursing home residents - ≥ 65 years of age - Able to give informed consent or consent by proxy

- Prior SARS-CoV-2 positive rtPCR test - Terminal illness - Current prescription of hydroxychloroquine or chloroquine - Allergy to hydroxychloroquine or chloroquine - Known to suffer from either of the following: Cardiomyopathy, G6PD deficiency, Retinopathy, Severe hearing -deficits, QT prolongation, Child Pugh Score = C, psoriasis, myasthenia gravis, dysregulated diabetes, eGFR < 20 ml/min - Deemed unable to swallow oral tablets - Intake of the following medication due to potential QT prolongation o Macrolides, quinolones, voriconazole, psychotropics with high risk of QT prolongation, amiodarone, or methadone Intake of the following medication due to potential interaction o Digoxin

2

Odense University Hospital

65

100

Denmark

High risk patients

N/A

206

SARS-CoV-2 positive rtPCR from nasopharyngeal samples during 2 months prophylactic treatment with hydroxychloroquine, vitamin D, and zinc supplement or no prophylactic treatment

Declared number of arm (2.0) differs from found arms (1.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]