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Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial (HASCOPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04365231
Recruitment Status : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital St. Joseph, Marseille, France

Study Description
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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 our 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365231


Contacts
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Contact: Xavier-Côme xcd Donato 33491806642 xdonato@hopital-saint-joseph.fr
Contact: Maria mg Gackiere 33491806642 mgackiere@hopital-saint-joseph.fr

Locations
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France
Hopital Saint Joseph
Marseille, Paca, France, 13008
Contact: Laurence CUREL    33491807112    lcurel@hopital-saint-joseph.fr   
Principal Investigator: Raoul RD Desbriere, MD         
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
More Information
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Responsible Party: Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT04365231    
Other Study ID Numbers: HASCOPT2020
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
 Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents