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| Column | Value |
|---|---|
| Trial registration number | NCT04365231 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Xavier-Côme Donato, xdonato@hopital-saint-joseph.fr (PI email not reported) |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-28 |
|
Recruitment status
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Withdrawn |
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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 |
Open label |
|
Center
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
unclear |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - pregnant - 18 and over - monofetal pregnancy between 22+0 and 41+0 weeks of gestation - presenting a positive covid-19 rt-pcr test result after nasopharyngeal swab for one or more minor symptoms: cough, body temperature >37,3 °c, shortness of breath, diarrhea, asthenia, anosmia, taste loss, myalgia - presenting no contraindication to hydroxychloroquine and azithromycin - informed consent signature - affiliated to social security scheme |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- allergic to hydroxychloroquine or chloroquine, or azithromycin - contraindication to hydroxychloroquine: retinopathy, g6pd deficiency, long qt syndrome, any other heart rhythm abnormality on pre-recruitment electrocardiogram, hypokalemia, porphyria, psoriasis. - contraindication to azithromycin: long qt syndrome, liver failure, myasthenia - receiving simultaneous treatments contraindicated in case of hydroxychloroquine uptake: citalopram (seropram), escitalopram (seroplex), hydroxyzin (atarax), domperidone (motilium), piperaquine (eurartesim), disopyramide (isorythm, rythmodan), hydroquinidine chlorydrate (serecor), amiodarone (cordarone), dronedaron (multaq), tricyclic antidepressant, anti-infectious drugs (macrolids, fluoroquinolones, trimethoprime-sulfamethoxazole (bactrim). - receiving simultaneous treatments contraindicated in case of azithromycin uptake: cisapride, colchicine, dihydroergotamine, bromocriptine, cabergoline, lisurid, pergolide, atorvastatin, ciclosporin, digoxin, simvastatin, anti-vitamine k, macrolids, ketolide - hypoxemic respiratory failure due to severe pneumonia (needing supplemental oxygen) - maternal disorders: type i or ii diabetes, congenital cardiopathy, liver or kidney disease, liver failure, renal failure - obstetrical disorders: insulin-dependent gestational diabetes, preterm delivery threat, preterm rupture of membranes, bleeding, pre-eclampsia, gestational hypertension, gestational cholestasis |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Hospital St. Joseph, Marseille, France |
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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 : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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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 : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Percentage of patients with a negative RT-PCR test result to COVID-19 |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+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"}] |