WithdrawnPhase 4

The Danish Pre-HCQ COVID Dialysis Study

Stopped: No funding

Denmark0Started 2020-04-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hospitalization due to SARS-CoV-2 infection

Timeframe: 3 months

Trial details

NCT IDNCT05110651

SponsorNicholas Carlson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-31

View on ClinicalTrials.gov More COVID-19 trials