Clinical trial NCT04329611: ALBERTA HOPE COVID-19 for the Prevention of Severe COVID19 Disease
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Oral Hydroxychloroquine for the Treatment of SARS-CoV-2 Positive Patients for the Prevention of Severe COVID-19 Disease.
Conditions: COVID-19
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).
Interventions:
description: COVID19
name: Hydroxychloroquine
other_name: plaquenil
type: Drug
Study arms:
design_group_description: hydroxychloroquine 400 mg po bid loading dose for 1 day followed by 200 mg po twice daily for 4 days
design_group_title: hydroxychloroquine
design_group_type: Active Comparator
design_group_description: Matching Placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Calgary
Collaborators: Province of Alberta
Alberta Innovates
Calgary Health Trust
University of Calgary
University of Alberta
Alberta Health Services
Drug name mappings:
name: 硫酸羟氯喹
lang: CN
name: Hydroxychloroquine Sulfate
lang: EN
name: ドロキシクロロキン硫酸塩
lang: JP