Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial (HASCOPT)
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ClinicalTrials.gov Identifier: NCT04365231 |
Recruitment Status :
Withdrawn
(no authorization obtained)
First Posted : April 28, 2020
Last Update Posted : November 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID19 | Drug: Hydroxychloroquine and azithromycin treatment Other: conventional management of patients | Phase 3 |
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 |

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 |
- 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.
- Maternal outcomes: Percentage of severe forms of the disease [ Time Frame: 25 weeks ]percentage of severe forms of the disease
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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: | 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 |
SARS-Cov-2 virus coronavirus disease COVID-19 epidemic pregnancy |
RT-PCR hydroxychloroquine azithromycin respiratory distress |
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 |