Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial

NCT04365231 | Withdrawn Phase 3

• 1 other identifier: HASCOPT2020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID19

Keywords

SARS-Cov-2 virus; coronavirus disease; COVID-19; epidemic; pregnancy; RT-PCR; hydroxychloroquine; azithromycin; respiratory distress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maternal outcomes: Percentage of severe forms of the disease

  25 weeks

• Newborn outcomes: Rate of newborns hospitalized in intensive care or transferred to resuscitation unit

  25 weeks

Study Arms (2)

Hydroxychloroquine and azithromycin treatment

EXPERIMENTAL

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.

Drug: Hydroxychloroquine and azithromycin treatment; Other: conventional management of patients

conventional management of patients

ACTIVE COMPARATOR

Regular management of patients

Other: conventional management of patients

Interventions

Hydroxychloroquine and azithromycin treatment DRUG

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.

Hydroxychloroquine and azithromycin treatment

conventional management of patients OTHER

conventional management of patients

Hydroxychloroquine and azithromycin treatment; conventional management of patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

MeSH Terms

Conditions

COVID-19; Dyspnea

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: April 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: April 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share