COVID-19, Hydroxychloroquine, Pregnant Women, SARS-CoV-2
Conditions
Keywords
COVID-19, SARS-CoV-2, Pregnancy, hydroxychloroquine
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.
Interventions
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.
DRUGPlacebo 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.
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Maternal outcomes | 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) |
| Newborn outcomes | Participants will be contacted within 2 weeks after delivery to obtain information about their baby. | Gestational age at delivery (weeks) |
Outcome results
None listed