COVID-19Phase 4NCT05110651
The Danish Pre-HCQ COVID Dialysis Study
A Phase 4 study testing Hydroxychloroquine in people with COVID-19 and End Stage Renal Disease, run by Nicholas Carlson at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, End Stage Renal Disease
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesDenmark
- Study dates
- 10 Apr 2020to 1 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Rigshospitalet
Copenhagen, Copenhagen, 2100
Herlev Hospital
Herlev, Herlev, 2730
North Zealand Hospital
Hillerød, Hillerød, 3400
About this study
Official title: The Danish Pre-HCQ Dialysis Study: Hydroxychloroquine for Prevention of COVID19 in Dialysis-treated Patients With End-stage Renal Disease - A Multicenter Parallel-group Open Randomized Clinical Trial
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.
Read the detailed description
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
- COVID-19, End Stage Renal Disease
- Being tested
- Hydroxychloroquine
- Medical subject headings
- COVID-19, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Oral Hydroxychloroquine 200mg once daily Dose tapered if blood-hydroxychloroquine levels > 2000ng/ml
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Active comparator | Oral hydroxychloroquine 200mg once daily Receives: Drug: Hydroxychloroquine |
| No treatment | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization due to SARS-CoV-2 infection
Number of patients hospitalized due to COVID-19
Measured: 3 months
Secondary outcomes (5)
SARS-CoV-2 infection
Number of patients with verified SARS-CoV-2 infection
Measured: 3 months
SARS-CoV-2 viral load
SARS-CoV-2 viral count as defined by real-time RNA polymerase chain reaction
Measured: 3 months
All-cause mortality
Number of deaths within the study period
Measured: 3 months
Requirement of mechanical ventilation
Number of patients requiring mechanical ventilation due to SARS-CoV-2 infection within the study period
Measured: 3 months
Admission to intensive care
Number of patients admitted to intensive care due to SARS-CoV-2 infection within the study period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start10 Apr 2020 (estimated)
- Primary completion31 Jul 2020
- Study completion1 Oct 2020
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter parallel-group open-label randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicholas Carlson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicholas Carlson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Nicholas Carlson, MD PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110651
- Sponsor's protocol ID
- D-Pre-HCQ-D104
- Status last verified
- May 2026
- First submitted
- 29 Mar 2020
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated de-identified individual participant data for primary and secondary outcomes measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Danish Pre-HCQ Dialysis Study: Hydroxychloroquine for Prevention of COVID19 in Dialysis-treated Patients With End-stage Renal Disease - A Multicenter Parallel-group Open Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05110651
- Acronym / sponsor ID
- D-Pre-HCQ-D104
- Conditions
- COVID-19, End Stage Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nicholas CarlsonUniversity, hospital or other
- Study start
- 10 Apr 2020 (estimated)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter parallel-group open-label randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Active comparator | Drug: HydroxychloroquineOral hydroxychloroquine 200mg once daily |
| No treatment | No intervention | –No treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: PlaquenilOral Hydroxychloroquine 200mg once daily Dose tapered if blood-hydroxychloroquine levels > 2000ng/ml | Drug | Hydroxychloroquine |
Primary outcome
Hospitalization due to SARS-CoV-2 infection
Time frame: 3 months
Number of patients hospitalized due to COVID-19
5 secondary outcomes
SARS-CoV-2 infection
Time frame: 3 months
SARS-CoV-2 viral load
Time frame: 3 months
All-cause mortality
Time frame: 3 months
Requirement of mechanical ventilation
Time frame: 3 months
Admission to intensive care
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Yes. Aggregated de-identified individual participant data for primary and secondary outcomes measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Carlson, MD PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxychloroquine in people with COVID-19 and End Stage Renal Disease, run by Nicholas Carlson at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization due to SARS-CoV-2 infection (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.