Status:
TERMINATED
ALBERTA HOPE COVID-19 for the Prevention of Severe COVID19 Disease
Lead Sponsor:
Dr. Michael Hill
Collaborating Sponsors:
Alberta Health services
University of Alberta
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Albertans with COVID-19 are at risk of deteriorating and developing severe illness. Those over age 40 or with co-morbid illness, and likely those who are immune suppressed, are at highest risk. This s...
Detailed Description
This double-blind placebo-controlled, randomized clinical trial will determine if hydroxychloroquine for 5 days, initiated within 96 hours of confirmation of a positive COVID-19 result, and within 12 ...
Eligibility Criteria
Inclusion
- Confirmed SARS-CoV-2 infection, defined as RT-PCR provincial laboratory confirmation.
- Self-reported symptoms of SARS-CoV-2 infection including any of the following: fever ≥37.5°C, cough, dyspnea, chest tightness, malaise, sore throat, myalgias, or coryza
- Time from a positive test result to day 1 of treatment within 4 days
- Time from patient reported first symptoms to day 1 of treatment within 12 days
- Adults, age 18 and over, with any risk factor for severe disease
- Resident of Alberta or if not a resident of Alberta able to provide complete follow-up data
- Agrees to use adequate contraception for the duration of the study
- Informed consent
Exclusion
- Currently or imminently planned admission to hospital
- Any contraindication to hydroxychloroquine :
- Known hypersensitivity to hydroxychloroquine, chloroquine, or other 4-aminoquinoline derivatives, or any component of the formulation
- Known diagnosis of G6PD deficiency or porphyria
- Known retinal eye disease with vision impairment, in which hydroxychloroquine is a known contraindication
- Known history of QTc prolongation or QTc of \> 470 msec (males) or \> 480 msec (females) on any ECG within the previous year, if available
- Unexplained syncope or family history of long QT syndrome or family history of premature sudden cardiac death at \< 50 years of age
- Severe diarrhea and/or vomiting or any eating disorders or any persistent vomiting condition
- Known significant liver disease including cirrhosis associated with any history of ascites, encephalopathy, or variceal bleeding as per history or medical chart (or Child Pugh B\&C) or alcoholic hepatitis
- Uncontrolled epilepsy (more than 2 seizures within the previous year or any hospitalizations for status epilepticus within the previous 2 years)
- Current use of hydroxychloroquine (Plaquenil), chloroquine, lumefantrine, mefloquine, quinine, artemether, cyclosporine, dapsone, digoxin, and drugs that are known to prolong the QTc as per section 7.5.2.
- Score of 7 or more on the Tisdale scale modified such that instead of (1) admission potassium, any known serum potassium within the previous 30 days will be used; if no serum potassium is available the sub-score will be 0, and (2) admission ECG, any known ECG within the previous year will be used; if no ECG is available, the sub-score will be 0; (3) Use of HCQ will be included as one risk factor and anyone concurrently using a medication from the list of drugs known to prolong the QTc will already be excluded. (The other major risk factors for prolonged QTc are sepsis, heart failure, acute myocardial infarction, none of which are likely to be encountered in the outpatient setting).
- Participation in an ongoing interventional clinical trial within the previous 30 days
- Use of hydroxychloroquine (Plaquenil) or chloroquine, lumefantrine, mefloquine, or quinine within the previous 30 days.
- Inability to swallow pills or any other reason that compliance with the medical regimen is not likely
- Pregnant or breastfeeding
- Severe underlying disease where treatment is not likely to be beneficial to the patient.
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2020
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04329611
Start Date
April 13 2020
End Date
July 20 2020
Last Update
July 31 2020
Active Locations (2)
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1
University of Calgary/Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
2
University of Alberta
Edmonton, Alberta, Canada