Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women (HyPreC)
Primary Purpose
COVID-19, SARS-CoV-2, Pregnant Women
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
hydroxychloroquine sulfate 200 MG
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, Pregnancy, hydroxychloroquine
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
hydroxychloroquine
Placebo
Arm Description
10-day course of hydroxychloroquine 200 mg tablet twice a day. To be taken orally.
An identical appearing placebo. To be taken orally twice a day for 10-days.
Outcomes
Primary Outcome Measures
COVID-19-related hospital admissions
COVID-19-related hospital admissions will be reported by the participants throughout pregnancy until delivery.
Secondary Outcome Measures
Symptoms related to COVID-19 infection
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
Side effects related to hydroxychloqoruine
Maternal outcomes
Type of delivery (elective non-urgent cesarean, elective urgent cesarean section, non-elective cesarean within labor, instrumental vaginal, spontaneous vaginal)
Maternal outcomes
If had cesarean delivery, indication for cesarean section
Maternal outcomes
Miscarriage or stillbirth (Yes/No)
Maternal outcomes
Labor induction or augmentation (Yes/No) and indication
Maternal outcomes
Epidural use (Yes/No)
Newborn outcomes
Gestational age at delivery (weeks)
Newborn outcomes
Sex (female/male)
Newborn outcomes
Birth weight (kg)
Birth weight (kg)
Newborn outcomes
Need for resuscitation (Yes/No)
Newborn outcomes
NICU admission (Yes/No)
Newborn outcomes
Medical conditions (jaundice, IVH, RDS, pneumothorax, PDA, NEC)
Newborn outcomes
Current disposition of baby (home or hospital)
Full Information
NCT ID
NCT04354441
First Posted
April 14, 2020
Last Updated
June 23, 2020
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04354441
Brief Title
Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women
Acronym
HyPreC
Official Title
Randomized Trial Evaluating Effect of Outpatient Hydroxychloroquine on Reducing Hospital Admissions in Pregnant Women With SARS-CoV-2 Infection: HyPreC Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Not started
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2, Pregnant Women, Hydroxychloroquine
Keywords
COVID-19, SARS-CoV-2, Pregnancy, hydroxychloroquine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hydroxychloroquine
Arm Type
Experimental
Arm Description
10-day course of hydroxychloroquine 200 mg tablet twice a day. To be taken orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An identical appearing placebo. To be taken orally twice a day for 10-days.
Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine sulfate 200 MG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
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 Measure Information:
Title
COVID-19-related hospital admissions
Description
COVID-19-related hospital admissions will be reported by the participants throughout pregnancy until delivery.
Time Frame
Hospital Admission at any point from study enrollment to delivery
Secondary Outcome Measure Information:
Title
Symptoms related to COVID-19 infection
Description
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.
Time Frame
Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
Title
Adverse Events
Description
Side effects related to hydroxychloqoruine
Time Frame
Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
Title
Maternal outcomes
Description
Type of delivery (elective non-urgent cesarean, elective urgent cesarean section, non-elective cesarean within labor, instrumental vaginal, spontaneous vaginal)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Title
Maternal outcomes
Description
If had cesarean delivery, indication for cesarean section
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Title
Maternal outcomes
Description
Miscarriage or stillbirth (Yes/No)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Title
Maternal outcomes
Description
Labor induction or augmentation (Yes/No) and indication
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Title
Maternal outcomes
Description
Epidural use (Yes/No)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Title
Newborn outcomes
Description
Gestational age at delivery (weeks)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Title
Newborn outcomes
Description
Sex (female/male)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Title
Newborn outcomes
Description
Birth weight (kg)
Birth weight (kg)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Title
Newborn outcomes
Description
Need for resuscitation (Yes/No)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Title
Newborn outcomes
Description
NICU admission (Yes/No)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Title
Newborn outcomes
Description
Medical conditions (jaundice, IVH, RDS, pneumothorax, PDA, NEC)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Title
Newborn outcomes
Description
Current disposition of baby (home or hospital)
Time Frame
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Citations:
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28561251
Citation
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PubMed Identifier
20367629
Citation
Mor G, Cardenas I. The immune system in pregnancy: a unique complexity. Am J Reprod Immunol. 2010 Jun;63(6):425-33. doi: 10.1111/j.1600-0897.2010.00836.x. Epub 2010 Mar 29.
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Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women
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