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| Column | Value |
|---|---|
| Trial registration number | NCT04322396 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Feb. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Feb. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
jens.ulrik.jensen@regionh.dk |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-03-26 |
|
Recruitment status
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Terminated |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : July 1, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - patient admitted to a danish emergency department, lung medical department or medical department - age >18 years - hospitalized <48 hours - positive covid-19 test/diagnosis during the hospitalization - signs informed consent |
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Exclusion criteria
Last imported at : July 1, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
- if the patient uses > 5 lo2/min at time of recruitment - known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinolinderivates - pregnancy - breastfeeding - neurogenic hearing loss - psoriasis - retinopathy - maculopathy - changes in vision field - severe liver disease other than amoebiases - severe gastrointestinal, neurological or haematological disorders - egfr < 45 ml/min/1.73m2 - clinically significant cardiac conduction disorders/arrhythmias or prolonged qtc interval - myasthenia gravis - uses digoxin - glucose-6-phosphate dehydrogenase deficiency - porphyria - hypoglycemia at any time since hospitalization - severe mental illness which significantly impedes cooperation - severe linguistic problems that significantly impedes cooperation - treatment with sickle alkaloids |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Dec. 4, 2022, 8 p.m. Source : ClinicalTrials.gov |
Chronic Obstructive Pulmonary Disease Trial Network, Denmark |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Denmark |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : Feb. 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
117 |
|
primary outcome
Last imported at : Dec. 4, 2022, 8 p.m. Source : ClinicalTrials.gov |
Number of Days Alive and Discharged From Hospital Within 14 Days |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Posted results also available to 2020-001198-55: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001198-55/results", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Posted results also available to 2020-001198-55: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001198-55/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |