Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial

COVID19 Clinical Trial

— HASCOPT  

Official title:

Efficacy Evaluation of Hydroxychloroquine Azithromycin in the Treatment of COVID-19 in Pregnant Women: an Open-label Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04365231
• Other study ID #: HASCOPT2020
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: November 2020
• Source: Hospital St. Joseph, Marseille, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID19

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a negative RT-PCR test result to COVID-19	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.	7 days
Secondary	Maternal outcomes: Percentage of severe forms of the disease	percentage of severe forms of the disease	25 weeks
Secondary	Newborn outcomes: Rate of newborns hospitalized in intensive care or transferred to resuscitation unit	rate of newborns hospitalized in intensive care or transferred to resuscitation unit	25 weeks