The Danish Pre-HCQ COVID Dialysis Study

NCT05110651 | Withdrawn Phase 4 DMC

• 1 other identifier: D-Pre-HCQ-D104
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

COVID-19; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Hospitalization due to SARS-CoV-2 infection

  Number of patients hospitalized due to COVID-19

  3 months

Secondary Outcomes (5)

• SARS-CoV-2 infection

  3 months

• SARS-CoV-2 viral load

  3 months

• All-cause mortality

  3 months

• Requirement of mechanical ventilation

  3 months

• Admission to intensive care

  3 months

Other Outcomes (9)

• Duration of hospitalization

  3 months

• Duration of mechanical ventilation

  3 months

• Duration of admission to intensive care

  3 months

Study Arms (2)

Hydroxychloroquine

ACTIVE COMPARATOR

Oral hydroxychloroquine 200mg once daily

Drug: Hydroxychloroquine

No treatment

NO INTERVENTION

No treatment

Interventions

Hydroxychloroquine DRUG

Oral Hydroxychloroquine 200mg once daily Dose tapered if blood-hydroxychloroquine levels \> 2000ng/ml

Also known as: Plaquenil

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicholas Carlson: lead

Study Sites (3)

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

North Zealand Hospital

Hillerød, Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

COVID-19; Kidney Failure, Chronic

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nicholas Carlson, MD PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Model Details: Multicenter parallel-group open-label randomized clinical trial

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: November 8, 2021
• Study Start: April 10, 2020
• Primary Completion: July 31, 2020
• Study Completion: October 1, 2020
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Aggregated data will be available within 12 months of study completion
• Access Criteria: All data access requests via email. Requestors will be required to sign a Data Access Agreement

Locations

DK (3)