Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women (HyPreC)
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ClinicalTrials.gov Identifier: NCT04354441 |
Recruitment Status :
Withdrawn
(Not started)
First Posted : April 21, 2020
Last Update Posted : June 25, 2020
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Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Information provided by (Responsible Party):
Haim Abenhaim, Sir Mortimer B. Davis - Jewish General Hospital
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Brief Summary:
COVID-19 was declared a pandemic on March 11th. Efforts to save lives are essential as we will face increasing morbidity with rising demands on health care resources. Since pregnant women with COVID-19 have systematically been excluded from drug trials, potential treatment options for these high-risk individuals remain untested. The aim of our trial is to determine whether hydroxychloroquine given to COVID-19 positive pregnant women can reduce COVID-19-related hospital admissions, thereby allowing women to stay at home while limiting utilization of hospital resources and resulting exposure of health care providers.
Condition or disease | Intervention/treatment | Phase |
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COVID-19 SARS-CoV-2 Pregnant Women Hydroxychloroquine | Drug: hydroxychloroquine sulfate 200 MG Drug: Placebo oral tablet | Phase 2 |
Due to physiologic and immune changes, pregnant women are at high risk of severe complications and mortality from COVID-19 infections. Despite this, epidemiologic data on SARS-CoV-2 infection in pregnancy is currently limited to small case-series describing a clinical course ranging from mild to critical illness requiring extracorporeal membrane oxygenation. Chloroquine and hydroxychloroquine (HCQ) have demonstrated activity against SARS-coronaviruses in laboratory studies and are being tested in COVID-19 positive patients. HCQ appears more promising than chloroquine due to its greater effectiveness against SARS-CoV-2 in vitro and better safety profile. To date, pregnant women have been systematically excluded from trials conducted in the general outpatient population. Thus, we will carry out a randomized, placebo-controlled, double blinded trial of HCQ (considered safe in pregnancy in pregnant women with early COVID-19 infection across Canada to evaluate its effect in reducing COVID-19-related hospitalizations. This outpatient intervention is of paramount importance as its goal is to avoid overloading emergency rooms, obstetric triage, inpatient wards and critical care units. Upon completion of 6-month, our results can be directly applied to clinical care.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants will be randomized 1:1 to receive either the study medication (hydroxychloroquine) or an identical-looking placebo. Randomization will be in blocks of 4-6, stratified by province. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Trial Evaluating Effect of Outpatient Hydroxychloroquine on Reducing Hospital Admissions in Pregnant Women With SARS-CoV-2 Infection: HyPreC Trial |
Estimated Study Start Date : | May 2020 |
Estimated Primary Completion Date : | May 2020 |
Estimated Study Completion Date : | May 2020 |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
Arm | Intervention/treatment |
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Experimental: hydroxychloroquine
10-day course of hydroxychloroquine 200 mg tablet twice a day. To be taken orally.
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Drug: hydroxychloroquine sulfate 200 MG
Hydroxychloroquine sulfate (Plaquenil) 2MG will be taken twice a day for 10 days. Participants will be couriered the medication upon giving consent and will start taking the medication immediately. |
Placebo Comparator: Placebo
An identical appearing placebo. To be taken orally twice a day for 10-days.
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Drug: Placebo oral tablet
Placebo that is identical in appearance to the study medication will be taken twice a day for 10 days. It will be couriered to participants upon giving consent. They will start taking the medication immediately. |
Primary Outcome Measures :
- COVID-19-related hospital admissions [ Time Frame: Hospital Admission at any point from study enrollment to delivery ]COVID-19-related hospital admissions will be reported by the participants throughout pregnancy until delivery.
Secondary Outcome Measures :
- Symptoms related to COVID-19 infection [ Time Frame: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery ]Measurement of reported symptoms using a validated questionnaire on Day 3, 7, 10, and every 2 weeks. The FLU-PRO Questionnaire instructs respondents to rate the severity of 37 influenza symptoms over the past 24 hours, including those related to the nose, throat, eye, chest, head, stomach, fatigue, and body aches/pains. For 32 of 37 items, respondents rated the severity of each symptom on 5-point Likert-type scales from 0 ("Not at all), 1 ("A little bit"), 2 ("Somewhat"), 3 ("Quite a bit"), to 4 ("Very much"). For the five remaining items, severity is expressed as frequency of occurrence: vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times), and sneezing, coughing, and coughed up mucus or phlegm on a scale from 0 ("Never") to 4 ("Always"), with higher scores indicating more severe symptoms.
- Adverse Events [ Time Frame: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery ]Side effects related to hydroxychloqoruine
- Maternal outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery. ]Type of delivery (elective non-urgent cesarean, elective urgent cesarean section, non-elective cesarean within labor, instrumental vaginal, spontaneous vaginal)
- Maternal outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery. ]If had cesarean delivery, indication for cesarean section
- Maternal outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery. ]Miscarriage or stillbirth (Yes/No)
- Maternal outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery. ]Labor induction or augmentation (Yes/No) and indication
- Maternal outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery. ]Epidural use (Yes/No)
- Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]Gestational age at delivery (weeks)
- Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]Sex (female/male)
- Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]
Birth weight (kg)
Birth weight (kg)
- Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]Need for resuscitation (Yes/No)
- Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]NICU admission (Yes/No)
- Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]Medical conditions (jaundice, IVH, RDS, pneumothorax, PDA, NEC)
- Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]Current disposition of baby (home or hospital)
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women with a self-reported live pregnancy >14 weeks
- Presently in the outpatient setting (i.e. not admitted to the hospital)
- Tested positive for COVID-19 within last 7 days
- Must be living in Canada
Exclusion Criteria:
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Known cardiac disease (or under investigation)
- Currently taking medication contraindicated as per Health Canada list for hydroxychloroquine
- Known retinopathy
- Known hypersensitivity to 4-aminoquinoline compounds
- Already taking hydroxychloroquine
- Unwilling to answer follow-up questionnaires
- Currently in labor
- Inpatient women at time of COVID-19 diagnosis.
No Contacts or Locations Provided
Publications:
Responsible Party: | Haim Abenhaim, Obstetrician & gynecologist; Director of Perinatal Research, Sir Mortimer B. Davis - Jewish General Hospital |
ClinicalTrials.gov Identifier: | NCT04354441 |
Other Study ID Numbers: |
1, March 30, 2020 |
First Posted: | April 21, 2020 Key Record Dates |
Last Update Posted: | June 25, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Haim Abenhaim, Sir Mortimer B. Davis - Jewish General Hospital:
COVID-19 SARS-CoV-2 Pregnancy hydroxychloroquine |
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 Hydroxychloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |