What are the ACT COVID-19 studies?
To evaluate various treatments to see if they can prevent people with COVID-19 from getting sicker, we are running 2 research studies:
People in the community who have tested positive for COVID-19 in the past 7 days: (Diagnosed in screening clinics, emergency room – but not admitted to hospital)
Symptomatic patients admitted to hospital with COVID-19 diagnosis
Have you tested positive for COVID-19 in the past 7 days?
You may be able to participate in the
ACT COVID-19 research study.
Who can participate?
We are seeking volunteers who are 18 years of age or older and are symptomatic with laboratory diagnosis of COVID-19. Volunteers below the age of 70 must have one of the following: male; obesity (BMI ≥30); chronic cardiovascular, respiratory or renal disease; active cancer; diabetes.
Individuals will be excluded from the study if they have allergy to study interventions, advanced kidney disease, advanced liver disease, pregnancy (known or potential) or lactation, already ventilated for >72 hours, known monoclonal gammopathy, history of severe depression/anxiety, high risk of bleeding or are already receiving the study interventions.
Individuals with current or planned use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin), P2Y12 inhibitors or therapeutic doses of anticoagulants (e.g., direct oral anticoagulants, vitamin K antagonists, heparin, LMWH), strong inhibitors of both CYP 3A4 and P-gp (e.g., lopinavir/ritonavir, carbamazepine, ketoconazole) will be excluded from the study.
Participation in this study is voluntary and choosing not to participate would not cause any penalty or loss of benefits to which someone is otherwise entitled. Participants can also stop their involvement in this study at any time without affecting their usual treatment.
The medicines being tested in this study will be supplied to participants FREE of charge.
Participants will not receive any compensation for participating in this study.
The ACT study has been reviewed by the Hamilton Integrated Research Ethics Board. The study is also registered at https://clinicaltrials.gov/ct2/show/NCT04324463
All information collected as part of this study will remain confidential except as required by law.
The study information will be stored for 25 years in a secure and protected electronic database located at the Population Health Research Institute, McMaster University, Canada.
ACT COVID-19 study procedures includes randomly assigning you to receive either study medication or usual care. The Anti-Coronavirus Therapy (ACT) trials have used a conceptual framework to identify several interventions that affect the disease at different stages. We will evaluate, in both outpatients and inpatients (mild/moderate and severe disease), several widely available interventions, alone and in combination, that potentially reduce viral load/viral entry ACT Trials (interferon β) and inflammation (colchicine); and prevent thrombosis (aspirin [ASA], rivaroxaban). We will collect information on progress at about 7 days, 45 days and 6 months after starting the trial.
Study Medication: May include various interventions or treatments, either separately or in combination.
- Outpatient trial – Symptomatic people in the community with a COVID-19 laboratory diagnosis (either individuals at screening clinics, in the emergency room but not admitted to hospital, or health care staff who have tested positive)
- For the outpatients (those in the community), study medications will be provided to you. Follow-up will be completed over the telephone.
- Inpatient trial – People admitted to hospital and who have a COVID-19 diagnosis.
- For inpatients (already in hospital) the hospital staff will take care of all study medication and follow-up will occur in the hospital or over the telephone if you have been discharged.
ACT COVID-19 Study Process
- Are you 18 years of age or older?
- Do you have symptoms and a laboratory confirmed diagnosis of COVID-19?
- Are you at high risk: either age ≥70 or one of the following: male; obesity (BMI ≥30); chronic cardiovascular, respiratory or renal disease; active cancer; diabetes?
- Are you within 7 days of diagnosis, or worsening clinically?
ACT Study Participation
- Person is enrolled in INPATIENT OR OUTPATIENT study depending on whether they are admitted to the hospital or not
You will receive study medications free of cost
- A follow-up visit will occur at the below times. Follow-up visits will be completed by telephone (Outpatient trial) or telephone and review of hospital records (Inpatient trial)
- 1st Follow-up: Day 7
- 2nd Follow-up: Day 45
- 3rd Follow-up: 6 months
Hamilton Health Sciences through Population Health Research Institute
Leadership for the ACT COVID-19 study
This clinical trial is not a substitute for medical advice. The Government of Canada Screening tool and information about COVID-19 can be found here: https://ca.thrive.health/covid19/en.
If you are having symptoms, reduce your contact with others, call your health care provider and follow the instructions provided by your Provincial Health Authority.
If you are having severe symptoms, call 911.
Provincial COVID-19 screening tools are available.
- In Ontario https://www.ontario.ca/page/2019-novel-coronavirus
- In Quebec https://www.quebec.ca/en/health/health-issues/a-z/general-information-about-coronavirus/
- In Manitoba https://sharedhealthmb.ca/covid19/screening-tool/
- In Alberta https://myhealth.alberta.ca/Journey/COVID-19/Pages/COVID-Self-Assessment.aspx