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The Danish Pre-HCQ COVID Dialysis Study

WithdrawnPhase 4

Sponsor: Nicholas Carlson

Conditions: COVID-19, End Stage Renal Disease

Interventions: Hydroxychloroquine

Countries: Denmark

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (3)

Copenhagen, Copenhagen, Denmark
Herlev, Herlev, Denmark
Hillerød, Hillerød, Denmark