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

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19; Hydroxychloroquine; Pregnant Women; SARS-CoV-2

Treatments: Drug: hydroxychloroquine sulfate 200 MG; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04354441

1, March 30, 2020

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

hydroxychloroquine

Experimental group

Description:

10-day course of hydroxychloroquine 200 mg tablet twice a day. To be taken orally.

Treatment:

Drug: hydroxychloroquine sulfate 200 MG

Placebo

Placebo Comparator group

Description:

An identical appearing placebo. To be taken orally twice a day for 10-days.

Treatment:

Drug: Placebo oral tablet