ALBERTA HOPE COVID-19 for the Prevention of Severe COVID19 Disease
Status:
Terminated
Trial end date:
2020-07-20
Target enrollment:
Participant gender:
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 study will include a focus on people with immune-suppressed states.
Individuals confirmed to have SARS-CoV-2 infection will be identified using administrative
data (positive lab result, age 18 or over, not hospitalized, and not living in SL4 level of
care). They will then be contacted by AHS staff, independent of the researchers, to obtain
their consent for the researchers to contact them about this trial. The AHS staff member who
contacts the individual will enroll consenting individuals into a study database. If they
provided an email address an email will automatically be sent to the individual with study
information. Those who decline to be contacted will also be informed of the study website so
they can choose to review the study information and self-enrol, although they will need to do
so quickly to meet study timelines. Enrolled participants will be contacted by a study
coordinator. Those without access to the internet will be informed about the study details
when they are contacted by a study coordinator. When the study coordinator contacts potential
participants the study will be reviewed, and the potential participant will have an
opportunity to ask questions. Consent for participation will be obtained by telephone.
Telephone consent will be recorded. Participants will then be screened for inclusion and
exclusion criteria by telephone interview and review of Alberta Netcare. Alberta Netcare is
the province of Alberta's public Electronic Health Record used to store patient information
so that it is easily accessible to healthcare professionals for the purpose of care.
Information like immunizations, ECG results, diagnostic images and reports, written medical
reports (e.g. surgery reports, consultations, hospital admissions), diagnostic lab testing
results (e.g. blood tests, urine tests, blood bank info), allergies and intolerances (drug
and food allergies, food intolerances), prescription history, and general patient information
(e.g. name, birthdate, personal health number, address, phone number). Those who are not
eligible for the study will be informed of the reason(s) for ineligibility (generally it will
be a safety exclusion and they should be aware of this). Those who are eligible will be
randomized to receive HCQ or placebo for a total duration of 5 days. Study drug will be
delivered to their residence by courier. Telephone follow-up will occur at day 7 (range 7-10
days) and at day 30 (range 25-35 days).
Phase:
Phase 3
Details
Lead Sponsor:
Dr. Michael Hill
Collaborators:
Alberta Health Services Alberta Innovates Health Solutions Calgary Health Trust Government of Alberta University of Alberta University of Calgary