COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001257-51/DK

Rigshospitalet - Department of Nephrology 2132

Not reported

2020-03-26

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Prevention

1. Patients ≥18 years on chronic dialysis due to end-stage renal disease. 2. Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent.

1. Prior verified SARS-CoV-2 infection 2. Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines 3. Electrocardiogram with QTc (Bazett’s formula) > 450 ms in males and 460 ms in females 4. Patients reliant on digoxin or amiodarone treatment 5. Pre-existing psoriasis 6. Any pre-existing maculopathy with vision reduction 7. Prior sensorineural hearing loss 8. Pre-existing severe liver insufficiency (spontaneous international normalized ratio >1.5 within the last year) 9. Pre-existing epileptic disease requiring anti-epileptic medication 10. Pregnancy or lactation 11. Insurmountable Language Barrier 12. Participation in other ongoing intervention trials investigating COVID19-related outcomes

2

Rigshospitalet

18

None

Denmark

High risk patients

N/A

568

The primary efficacy outcome of hospitalization due to SAR-COV-2 infections will be compared between patients allocated hydroxychloroquine and no 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"}]