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The Danish Pre-HCQ COVID Dialysis Study

NCT ID: NCT05110651

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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The emergence of a novel betacoronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to a global pandemic with profound implications for public health. Despite sweeping containment measures, spread of infection is ongoing, with potential ramifications pertaining to availability of health care resources. Preliminary data from Wuhan, China and Northern Italy indicate particular vulnerability of patients \>60 years with pre-existing comorbidity leading to increased risk of hospitalization and death. Currently, no specific treatment has demonstrated efficacy against infection with SARS-CoV-2 in a clinical trial. However, chloroquine has been shown to inhibit both viral entry and replication in infection with SARS-CoV-2 in vitro; albeit the specific mechanisms remain unchartered. Chloroquine is an amine acidotropic form of quinine. Previously a first-choice front-line drug for the treatment and prophylaxis of malaria, chloroquine remains one of the most prescribed drugs worldwide. The possible benefit of prophylactic treatment with hydroxychloroquine for mitigation of risk of manifest SARS-COV-2 remains untested. The on-going pandemic entails particular risk for patients on chronic dialysis; chronic dialysis is both associated with profound comorbidity but also requirement of continued ambulant hospital based treatment leading to increased exposure. Consequently, the potential benefit of preventative measures is greatly increased.

Aims and objectives The main objective of the following multicenter parallel-group open-label randomized clinical trial aims to investigate the possible benefit of initiating prophylactic hydroxychloroquine versus no treatment in patients on chronic dialysis for mitigation of risk related to SARS-CoV-2. The anticipated results will provide evidence as to the appropriateness of initiating prophylactic treatment for prevention of symptomatic SARS-CoV-2 in a vulnerable comorbid population with direct and immediate implications for clinical management and public health care beyond renal failure.

Methods A total of 568 dialysis-treated patients with end-stage renal disease will be recruited from all dialysis centers (including satellites) in the Capital region. Patients will be randomized to either oral hydroxychloroquinesulphate 200mg once daily or no treatment for three months. The study is planned as a multicenter, open-label, parallel-group pragmatic randomized clinical study.

Additionally, 100 participants on chronic in-center hemodialysis treatment will be invited to participate in a sub-study focused on SARS-CoV-2 screening and prevention. Patients will undergo screening based on oro-pharyngeal sampling twice weekly. If ≥ 20% of infected patients are identified prior to development of symptoms, results will be applied to advise early SARS-CoV-2 screening in all chronic in-center hemodialysis patients.

Conditions

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COVID-19 End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter parallel-group open-label randomized clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hydroxychloroquine

Oral hydroxychloroquine 200mg once daily

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type DRUG

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

No treatment

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydroxychloroquine

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

Intervention Type DRUG

Other Intervention Names

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Plaquenil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nicholas Carlson

OTHER

Sponsor Role lead

Responsible Party

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Nicholas Carlson

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nicholas Carlson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Herlev Hospital

Herlev, , Denmark

Site Status

North Zealand Hospital

Hillerød, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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D-Pre-HCQ-D104

Identifier Type: -

Identifier Source: org_study_id