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Clinical Trial Details

Trial ID: L1125
Source ID: NCT05110651
Associated Drug: Hydroxychloroquine
Title: The Danish Pre-HCQ COVID Dialysis Study
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: COVID-19|End Stage Renal Disease
Interventions: DRUG: Hydroxychloroquine
Outcome Measures: Primary: Hospitalization due to SARS-CoV-2 infection, Number of patients hospitalized due to COVID-19, 3 months | Secondary: SARS-CoV-2 infection, Number of patients with verified SARS-CoV-2 infection, 3 months|SARS-CoV-2 viral load, SARS-CoV-2 viral count as defined by real-time RNA polymerase chain reaction, 3 months|All-cause mortality, Number of deaths within the study period, 3 months|Requirement of mechanical ventilation, Number of patients requiring mechanical ventilation due to SARS-CoV-2 infection within the study period, 3 months|Admission to intensive care, Number of patients admitted to intensive care due to SARS-CoV-2 infection within the study period, 3 months | Other: Duration of hospitalization, Duration in days of hospitalization due to SARS-CoV-2 infection, 3 months|Duration of mechanical ventilation, Duration in day of mechanical ventilation due to SARS-CoV-2 infection, 3 months|Duration of admission to intensive care, Duration in days of admission to intensive care due to SARS-CoV-2 infection, 3 months|Bone marrow suppression, Number of patients with leucopeni \< 3000/μL within the study period, 3 months|Hepatic dysfunction, Number of patients with hepatic dysfunction as defined by an alanine transaminaease \> 250U/I within the study period, 3 months|Cardiac injury, Number of patients with evidence of cardiac injury (creatinine kinase-myocardial band \> 5μg/L) within the study period, 3 months|Sudden cardiac death, Number of patients with sudden cardiac death within the study period, 3 months|QTc prolongation, Number of patients with QTc prolongation (Bazett's formula; \>\> 450 ms in males and 460 ms in females), 3 months|Positiv SARS-CoV-2 antibody, Number of patients with positive SARS-CoV-2 antibody at 3 months, 3 months
Sponsor/Collaborators: Sponsor: Nicholas Carlson
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2020-04-10
Completion Date: 2020-10-01
Results First Posted:
Last Update Posted: 2021-11-08
Locations: Rigshospitalet, Copenhagen, 2100, Denmark|Herlev Hospital, Herlev, 2730, Denmark|North Zealand Hospital, Hillerød, 3400, Denmark
URL: https://clinicaltrials.gov/show/NCT05110651