Official Title
Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial
Brief Summary

The objectives of PROVIDE are to: 1. Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive 2. To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms 3. To determine the safety of taking weekly prophylactic hydroxychloroquine

Withdrawn
Corona Virus Infection

Drug: Apo-Hydroxychloroquine

Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.

Drug: Matched Placebo

Matching Placebo

Eligibility Criteria

Inclusion Criteria:

- 18 years of age or older to participate.

- Healthcare workers with primary practice in intensive care unit, general internal
medicine,

- COVID-19 testing centres, emergency rooms, and nursing homes.

- COVID_19 symptom free at the time of randomization and have a negative diagnostic
swab.

Exclusion Criteria:

- Known COVID-19 positivity defined as: a laboratory confirmed case as defined by the
local public health institutes

- Suspected COVID-19 positivity defined as possessing symptoms consistent with COVID-19
infections such as: headache, fever, nausea, vomiting, diarrhea, dyspnea, dry cough

- Healthcare workers with pre-existing retinopathy or serious visual problems

- Healthcare workers with known malignancies receiving active chemotherapy or immune
modifying medications

- Healthcare workers with known autoimmune disorders

- Healthcare workers with known QT prolongation

- History of ventricular arrhythmias

- Participants at risk of malignant arrythmias ○ At risk defined as: A sudden loss of
consciousness with injury; anyone in their immediate family, under the age of 45year,
with sudden cardiac death; anyone family history of long QT syndrome

- Known sensitivity/allergy to hydroxychloroquine

- Healthcare workers that are currently pregnant

- Healthcare workers that are already taking chloroquine or hydroxychloroquine

- Healthcare workers on colchicine or any other anti-viral medication

- Healthcare workers taking a medication that may interact with hydroxychloroquine
(see table below

- Inability to take oral medications

- Inability to provide written consent

- Known G6PD deficiency

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Canada
Locations

St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton
NCT Number
MeSH Terms
Coronavirus Infections
Hydroxychloroquine