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.
Drug: Hydroxychloroquine and azithromycin treatment
hydroxychloroquine 10-day course of hydroxychloroquine 200 mg tablet three times a day. To be taken orally.
- azithromycin 5-day course of azithromycin 250 mg tablet twice a day on the first day of treatment, then once a day the 4 following days.
Other: conventional management of patients
conventional management of patients
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