COVID19Phase 3HASCOPTNCT04365231
Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial
A Phase 3 study testing Hydroxychloroquine and azithromycin treatment and conventional management of patients in people with COVID19, run by Hospital St. Joseph, Marseille, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- COVID19
- What is being tested?
- Hydroxychloroquine and azithromycin treatment and conventional management of patients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Efficacy Evaluation of Hydroxychloroquine Azithromycin in the Treatment of COVID-19 in Pregnant Women: an Open-label Randomized Clinical Trial
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
- Being tested
- Hydroxychloroquine and azithromycin treatment, conventional management of patients
- Keywords
- SARS-Cov-2 virus, coronavirus disease, COVID-19, epidemic, pregnancy, RT-PCR, hydroxychloroquine, azithromycin, respiratory distress
- Medical subject headings
- COVID-19, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine and azithromycin treatmentDrug
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.
conventional management of patientsOther
conventional management of patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hydroxychloroquine and azithromycin treatment; Other: conventional management of patients |
| conventional management of patients | Active comparator | Regular management of patients Receives: Other: conventional management of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (2)
Maternal outcomes: Percentage of severe forms of the disease
percentage of severe forms of the disease
Measured: 25 weeks
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
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Apr 2020
- Primary completion1 Jun 2020
- Study completion1 Apr 2021 (estimated)
Why it stopped: no authorization obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365231
- Sponsor's protocol ID
- HASCOPT2020
- Acronym
- HASCOPT
- Status last verified
- Nov 2020
- First submitted
- 23 Apr 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Hydroxychloroquine Azithromycin in the Treatment of COVID-19 in Pregnant Women: an Open-label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04365231
- Acronym / sponsor ID
- HASCOPT / HASCOPT2020
- Conditions
- COVID19
- Keywords
- SARS-Cov-2 virus, coronavirus disease, COVID-19, epidemic, pregnancy, RT-PCR, hydroxychloroquine, azithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no authorization obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine and azithromycin treatment | Experimental | Drug: Hydroxychloroquine and azithromycin treatment, Other: conventional management of patientshydroxychloroquine 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. |
| conventional management of patients | Active comparator | Other: conventional management of patientsRegular management of patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine and azithromycin treatmenthydroxychloroquine 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 |
| conventional management of patientsconventional management of patients | Other | Hydroxychloroquine and azithromycin treatment, conventional management of patients |
Primary outcome
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.
2 secondary outcomes
Maternal outcomes: Percentage of severe forms of the disease
Time frame: 25 weeks
Newborn outcomes: Rate of newborns hospitalized in intensive care or transferred to resuscitation unit
Time frame: 25 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine and azithromycin treatment and conventional management of patients in people with COVID19, run by Hospital St. Joseph, Marseille, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a negative RT-PCR test result to COVID-19 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.