Status:
WITHDRAWN
Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial
Lead Sponsor:
Hospital St. Joseph, Marseille, France
Conditions:
COVID19
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Up to date, and since December 31st 2019, 2 520 522 cases of COVID-19 including 176 786 deaths, have been reported worldwide. Global efforts are made to save lives and decrease morbidity by evaluating...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04365231
Start Date
April 1 2020
End Date
April 1 2021
Last Update
November 20 2020
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