COVID19
Conditions
Keywords
SARS-Cov-2 virus, coronavirus disease, COVID-19, epidemic, pregnancy, RT-PCR, hydroxychloroquine, azithromycin, respiratory distress
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 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.
Interventions
DRUGHydroxychloroquine 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.
OTHERconventional management of patients
conventional management of patients
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a negative RT-PCR test result to COVID-19 | 7 days | Percentage of patients with a negative RT-PCR test result to COVID-19 nasopharyngeal swab at the 7th day of treatment by hydroxychloroquine and azithromycin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal outcomes: Percentage of severe forms of the disease | 25 weeks | percentage of severe forms of the disease |
| Newborn outcomes: Rate of newborns hospitalized in intensive care or transferred to resuscitation unit | 25 weeks | rate of newborns hospitalized in intensive care or transferred to resuscitation unit |
Outcome results
None listed