Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women
- Conditions
- SARS-CoV-2Pregnant WomenHydroxychloroquineCOVID-19
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT04354441
- Lead Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hydroxychloroquine hydroxychloroquine sulfate 200 MG 10-day course of hydroxychloroquine 200 mg tablet twice a day. To be taken orally. Placebo Placebo oral tablet An identical appearing placebo. To be taken orally twice a day for 10-days.
- Primary Outcome Measures
Name Time Method COVID-19-related hospital admissions 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
Name Time Method Symptoms related to COVID-19 infection 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 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
Newborn outcomes Participants will be contacted within 2 weeks after delivery to obtain information about their baby. Current disposition of baby (home or hospital)
Maternal outcomes Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery. Epidural use (Yes/No)