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.
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.
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.
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.
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.