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

June 23, 2020 updated by: Haim Abenhaim, Sir Mortimer B. Davis - Jewish General Hospital

Randomized Trial Evaluating Effect of Outpatient Hydroxychloroquine on Reducing Hospital Admissions in Pregnant Women With SARS-CoV-2 Infection: HyPreC Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Hospital Admission at any point from study enrollment to delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
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
Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
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)
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
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
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
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)
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
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
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
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)
Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Newborn outcomes
Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Gestational age at delivery (weeks)
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Sex (female/male)
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
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)
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Need for resuscitation (Yes/No)
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Time Frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
NICU admission (Yes/No)
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
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)
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
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)
Participants will be contacted within 2 weeks after delivery to obtain information about their baby.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sir Mortimer B. Davis - Jewish General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1, March 30, 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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