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Trial - NCT04372082


Column Value
Trial registration number NCT04372082
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04372082

First author
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Karine Faure, MD,PhD

Contact
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

karine.faure@chru-lille.fr

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-01

Recruitment status
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - positive sars-cov-2 test on nasopharyngeal swab - onset of symptoms <8 days prior to randomization - news score<4 and no item ≥2 - at least one comorbidity among: age ≥ 70 years old, history of cardiac disease, diabetes, obesity, chronic kidney disease, chronic respiratory failure, immunosuppression, neoplasia, liver failure (stage ≥ child-pugh b) - fully able to understand the challenges of the trial - signed informed consent - covered by health insurance

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

for all patients: - inability to decide to participate - pregnancy or breath feeding - hypersensitivity to any of the test drugs - stage 4 or 5 chronic kidney disease (dfg <30 ml/min/1.73 m²) for hydroxychloroquine arm: - long qt syndrome or qtc space >500 ms - treatment with piperazine, halofantrine, dasatinib, nilotinib, citalopram, escitalopram, hydroxyzine, domperidone - hepatic porphyria, retinopathy, known glucose-6-phosphate dehydrogenase deficiency, - heart rate <50/min - hypokaliemia < 3.5 mmol/l for diltiazem arm: - heart rate<40/min - sinus bradycardia, second- or third-degree atrioventricular block - left heart insufficiency with pulmonary stasis - treatment with dantrolene, pimozide, dihydroergotamine, ergotamine, nifedipine, ivabradine, esmolol, bêta-blockers (bisoprolol, carvedilol, metoprolol, nebivolol), fingolimod

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University Hospital, Lille

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

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

death;clinical worsening (composite criteria);Assisted-ventilation and/or hospitalization (composite criteria)

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 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1485, "treatment_name": "Diltiazem+niclosamide", "treatment_type": "Cardiovascular agents+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]