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Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women (HyPreC)

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: NCT04354441
Recruitment Status : Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Haim Abenhaim, Sir Mortimer B. Davis - Jewish General Hospital

Study Description
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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
COVID-19 SARS-CoV-2 Pregnant Women Hydroxychloroquine Drug: hydroxychloroquine sulfate 200 MG Drug: Placebo oral tablet Phase 2

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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 : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: hydroxychloroquine
10-day course of hydroxychloroquine 200 mg tablet twice a day. To be taken orally.
 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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

  3. 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)

  4. 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

  5. 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)

  6. 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

  7. 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)

  8. Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]
    Gestational age at delivery (weeks)

  9. Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]
    Sex (female/male)

  10. 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)


  11. Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]
    Need for resuscitation (Yes/No)

  12. Newborn outcomes [ Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby. ]
    NICU admission (Yes/No)

  13. 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)

  14. 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)


Eligibility Criteria
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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.
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): NCT04354441


Contacts
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Contact: Haim Abenhaim 514-340-8222 ext 24199 andrea.spence@ladydavis.ca

Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
More Information
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Publications:

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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: April 21, 2020
Last Verified: April 2020

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