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Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial (HASCOPT)

Primary Purpose

COVID19

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hydroxychloroquine and azithromycin treatment
conventional management of patients
Sponsored by
Hospital St. Joseph, Marseille, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19 focused on measuring SARS-Cov-2 virus, coronavirus disease, COVID-19, epidemic, pregnancy, RT-PCR, hydroxychloroquine, azithromycin, respiratory distress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hydroxychloroquine and azithromycin treatment

    conventional management of patients

    Arm Description

    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.

    Regular management of patients

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Maternal outcomes: Percentage of severe forms of the disease
    percentage of severe forms of the disease
    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

    Full Information

    First Posted
    April 23, 2020
    Last Updated
    November 18, 2020
    Sponsor
    Hospital St. Joseph, Marseille, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04365231
    Brief Title
    Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial
    Acronym
    HASCOPT
    Official Title
    Efficacy Evaluation of Hydroxychloroquine Azithromycin in the Treatment of COVID-19 in Pregnant Women: an Open-label Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no authorization obtained
    Study Start Date
    April 1, 2020 (Actual)
    Primary Completion Date
    June 1, 2020 (Actual)
    Study Completion Date
    April 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital St. Joseph, Marseille, France

    4. Oversight

    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

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID19
    Keywords
    SARS-Cov-2 virus, coronavirus disease, COVID-19, epidemic, pregnancy, RT-PCR, hydroxychloroquine, azithromycin, respiratory distress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydroxychloroquine and azithromycin treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    conventional management of patients
    Arm Type
    Active Comparator
    Arm Description
    Regular management of patients
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxychloroquine and azithromycin treatment
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    conventional management of patients
    Intervention Description
    conventional management of patients
    Primary Outcome Measure Information:
    Title
    Percentage of patients with a negative RT-PCR test result to COVID-19
    Description
    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.
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Maternal outcomes: Percentage of severe forms of the disease
    Description
    percentage of severe forms of the disease
    Time Frame
    25 weeks
    Title
    Newborn outcomes: Rate of newborns hospitalized in intensive care or transferred to resuscitation unit
    Description
    rate of newborns hospitalized in intensive care or transferred to resuscitation unit
    Time Frame
    25 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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