The Danish Pre-HCQ COVID Dialysis Study

• Status: Withdrawn
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Hydroxychloroquine has been shown to inhibit replication of SARS-CoV-2 in vitro. The presented multicenter parallel-group open-label randomized clinical trial aims to investigate the efficacy of prophylactic hydroxychloroquine on mitigation of risk of hospitalization due to COVID-19 in patients with end-stage renal disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicholas Carlson
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• Patients ≥18 years on chronic dialysis due to end-stage renal disease.

• Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent.

Exclusion Criteria:

• Prior verified SARS-CoV-2 infection.

• Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines

• Electrocardiogram with QTc (Bazett's formula) > 450 ms in males and 460 ms in females

• Patients reliant on digoxin or amiodarone treatment

• Pre-existing psoriasis

• Any pre-existing maculopathy with vision reduction

• Prior sensorineural hearing loss

• Pre-existing severe liver insufficiency (spontaneous international normalized ratio >1.5 within the last year)

• Pre-existing epileptic disease requiring anti-epileptic medication

• Pregnancy or lactation

• Insurmountable Language Barrier

• Participation in other ongoing intervention trials investigating COVID19-related outcomes