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| Column | Value |
|---|---|
| Trial registration number | NCT05110651 |
|
Full text link
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
2021-11-08 |
|
Recruitment status
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
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
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
- 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 |
|
Number of arms
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Nicholas Carlson |
|
Inclusion age min
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Denmark |
|
Type of patients
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
High risk patients |
|
Severity scale
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Hospitalization due to SARS-CoV-2 infection |
|
Notes
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : Nov. 9, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |