NCT04365231

Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital St. Joseph, Marseille, France · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-04-01
• Primary completion: 2020-06-01
• Completion: 2021-04-01
• First posted: 2020-04-28
• Last updated: 2020-11-20