COVID-19 PEP- High-risk Individuals in Long-term and Specialized Care - Canada
COVID-19
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Hydroxychloroquine, Double Blind Randomized Control Trial, Prophylaxis, High risk, Long term / specialized care
Eligibility Criteria
Inclusion Criteria:
Age over 40 with two or more high-risk comorbidities that have been found to confer a higher risk of mortality including but not limited to :
chronic lung disease to include: Chronic obstructive lung disease, interstitial lung disease or diffuse parenchymal disease moderate to severe asthma
- Cardiac conditions to include: recent myocardial infarction (within the last three months) or poorly controlled heart failure
- severe obesity (body mass index [BMI] of 40 or higher)
- Diabetes (type 1 or 2)
- chronic kidney disease undergoing dialysis
- liver cirrhosis
OR Age over 60.
- Patient/resident in an Institute (to include a rehabilitation, long term care facility, mental health facility or veteran's care) that provides bed-based care in shared semi-private or ward rooms (i.e. two or more to a room) with a patient with confirmed COVID-19 for at least 6 hours in the absence of contact and droplet precautions.
- Exposure with a documented or suspected COVID-19 case or from a symptomatic ( defined as common symptoms of COVID-19 including but not limited to fever, lethargy, dry cough, shortness of breath) health care worker providing direct patient contact within 3 feet without a mask for > 15min or any physical contact with the staff. Exposure may occur in single or shared bedrooms. Exposure may occur in a common dining or activity or sitting area. Any patient sharing a room or within 3 feet for > 15min or any physical contact without a mask will be considered as a contact. Patients or staff are considered as infectious for 48hrs before any symptoms onset and until masked or cleared by 2 negative swabs.
- No prior treatment with acetaminophen or NSAIDs or willing to stop present prescription of regular or PRN acetaminophen.
- Informed consent (in person or by telephone/e-mail with SDM)
Exclusion Criteria:
- Greater than 96 hours since last exposure
- Presence of fever (T>37.8), new onset cough, or shortness of breath at enrollment
- A baseline O2 saturation less than 90% (as measured by pulse oximetry) on room air
- Screening ECG QTc interval greater than 500ms by either a 12 lead or 6 lead ECG.
- Concomitant drug-drug interactions (Artemether, Dapsone, Lumefantrine or Mefloquine amiodarone, digoxin, dofetilide, flecainide, procainamide, sotalol, or propafenone levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, or itraconazole methadone sumatriptan, or zolmitriptan systemic chemotherapy.)
- Already on active palliative care measures (Palliative performance score (PPS) less than 30%)
- Hypersensitivity reaction to chloroquine, hydroxychloroquine or aminoquinolines
- History of retinal disease due to previous use of 4-aminoquinoline
- Prior documented and known at enrollment, retinal eye disease or maculopathy including but not limited to diabetic retinopathy, retinal detachment, retinitis pigmentosa or macular degeneration
- Known glucose-6 phosphate dehydrogenase (G6PD) deficiency
- Known Porphyria
- Acute delirium
- Inability to swallow oral study drug/placebo (even after crushed in the same manner as regular prescribed medications)
- Diagnosis of immunodeficiency (e.g. HIV, transplantation) or receiving systemic steroid therapy (>10mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment
- Women who are pregnant or breastfeeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Hydroxychloroquine 200mg
Placebo Arm
Regular Dose 400mg orally once, followed in 8 hours by 400mg, then 200mg twice a day for 4 consecutive days (5 days in total) Modified Dose 400mg orally once, followed in 8 hours by 400mg, then 200mg once a day for 4 consecutive days (5 days in total) Modified doses are for individuals with body weight below 40 kg, renal impairment with a creatinine clearance less than 10mls/min or QTc interval greater than 480 but less than 500.
The placebo arm will be matched to study drug to maintain the study blind. Regular Dose Placebo 2 tabs once, followed in 8 hours by 2 tabs, then 1 tab twice a day for 4 consecutive days (5 days in total) Modified Dose Placebo 2 tabs once, followed in 8 hours by 2 tabs, then 1 tab once a day for 4 consecutive days (5 days in total) Modified doses are for individuals with body weight below 40 kg, renal impairment with a creatinine clearance less than 10mls/min or QTc interval greater than 480 but less than 500.