Hydroxychloroquine for prevention of COVID-19 in patients on chronic dialysis

Phase 1

• Conditions: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); MedDRA version: 20.1Level: PTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10038695Term: Respiratory failureSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: LLTClassification code 10023420Term: Kidney failure chronicSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001257-51-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-26
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 568

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified