Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial (HASCOPT)

• ClinicalTrials.gov Identifier: NCT04365231
• Recruitment Status: Withdrawn
• First Posted: April 28, 2020
• Last Update Posted: November 20, 2020
• Sponsor: Hospital St. Joseph, Marseille, France
• Information provided by (Responsible Party): Hospital St. Joseph, Marseille, France

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID19	Drug: Hydroxychloroquine and azithromycin treatment; Other: conventional management of patients	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy Evaluation of Hydroxychloroquine Azithromycin in the Treatment of COVID-19 in Pregnant Women: an Open-label Randomized Clinical Trial
• Actual Study Start Date: April 1, 2020
• Actual Primary Completion Date: June 1, 2020
• Estimated Study Completion Date: April 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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
Active Comparator: conventional management of patients; Regular management of patients	Other: conventional management of patients; conventional management of patients

Outcome Measures

Primary Outcome Measures :

1. Percentage of patients with a negative RT-PCR test result to COVID-19 [ Time Frame: 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 Outcome Measures :

1. Maternal outcomes: Percentage of severe forms of the disease [ Time Frame: 25 weeks ]
   percentage of severe forms of the disease
2. Newborn outcomes: Rate of newborns hospitalized in intensive care or transferred to resuscitation unit [ Time Frame: 25 weeks ]
   rate of newborns hospitalized in intensive care or transferred to resuscitation unit

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Hospital St. Joseph, Marseille, France
• ClinicalTrials.gov Identifier: NCT04365231
• Other Study ID Numbers: HASCOPT2020
• First Posted: April 28, 2020
• Last Update Posted: November 20, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hospital St. Joseph, Marseille, France:

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

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Azithromycin; Hydroxychloroquine; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents