Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) MedDRA version: 20.1 Level: PT Classification code 10053983 Term: Corona virus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10038695 Term: Respiratory failure System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10023420 Term: Kidney failure chronic System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Plaquenil
Pharmaceutical Form: Tablet
INN or Proposed INN: HYDROXYCHLOROQUINE
CAS Number: 118-42-3
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 200-
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 168 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the following multicentre parallel-group open randomized clinical trial aims to investigate the benefit, tolerability, and safety of initiating prophylactic hydroxychloroquine versus no treatment in patients on chronic dialysis in Denmark. The anticipated results from this project will provide evidence as to the appropriateness of initiating prophylactic treatment for prevention of symptomatic SAR-COV-2 in dialysis populations with direct effects on clinical management and guidelines pertaining to these patients.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy outcome of hospitalization due to SAR-COV-2 infections will be compared between patients allocated hydroxychloroquine and no treatment.;Timepoint(s) of evaluation of this end point: End of study as defined by 3 months following last inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes will include; SAR-COV-2 infection without hospitalization, requirement of mechanical ventilation due to SAR-COV-2 infection, SAR-COV-2-related mortality, all-cause mortality, duration of SAR-COV-2 infection, and admission to intensive care.;Timepoint(s) of evaluation of this end point: End of study as defined by 3 months following last inclusion | — |
Countries
Denmark
Contacts
Public ContactDepartment of Nephrology 2132
Rigshospitalet
Outcome results
None listed