Clinical trial NCT04354441: Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women
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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
SARS-CoV-2
Pregnant Women
Hydroxychloroquine
Keywords: COVID-19
SARS-CoV-2
Pregnancy
hydroxychloroquine
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: COVID-19-related hospital admissions
timeFrame: Hospital Admission at any point from study enrollment to delivery
Secondary outcomes:
measure: Symptoms related to COVID-19 infection
timeFrame: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
measure: Adverse Events
timeFrame: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
measure: Maternal outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
measure: Maternal outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
measure: Maternal outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
measure: Maternal outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
measure: Maternal outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
measure: Newborn outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
measure: Newborn outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
measure: Newborn outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
measure: Newborn outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
measure: Newborn outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
measure: Newborn outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
measure: Newborn outcomes
timeFrame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Other outcomes:
Locations:
Study officials:
References:
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