hydroxychloroquine azithromycin covid-19 pregnancy trial

Conditions: COVID19

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 therapeutic strategies. pregnant women with covid-19 are at high-risk of severe complications and mortality from covid-19 infection, due to physiologic and immune changes occurring during pregnancy. these risks include development of maternal hypoxemic respiratory failure due to severe pneumonia, hospitalization in intensive care, death; but also, fetal morbidity-mortality with chronic and/or acute fetal distress, intrauterine growth retardation, intrauterine death and neonatal morbidity, mainly due to induced preterm birth and maternal-fetal transmission. knowledge of these epidemiologic facts on sars-cov-2 infection in pregnant women is currently limited to small case-series. no drug has demonstrated solid evidence in treating sars-cov-2 virus. nevertheless, in vitro studies and tests in covid-19 positive patients treated with hydroxychloroquine and azithromycin merit further evaluation. pregnant women are systematically excluded from drug trials, and treatment options for this high-risk population remain untested. the aim of this study is to screen pregnant women presenting minor symptoms, for covid-19 and to evaluate efficacy of hydroxychloroquine-azithromycin treatment in preventing aggravation of symptoms with development of hypoxemic respiratory failure and complications of pregnancy.


Eligibility criteria:
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: * 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

Keywords: sars-cov-2 virus coronavirus disease covid-19 epidemic pregnancy rt-pcr hydroxychloroquine azithromycin respiratory distress