Anti-Coronavirus Therapies to Prevent Progression of COVID-19 (ACT) Study

ACT COVID-19

What is the ACT study?

The Anti-Coronavirus Therapies to Prevent Progression of COVID-19 (ACT) study will evaluate various treatments to see if they can prevent people with COVID-19 from getting sicker. The study consists of two trials, at the same time, of people who have tested positive for COVID-19:

People in the community who have a COVID-19 diagnosis
(individuals at screening clinics, in the emergency room but are not admitted to hospital, or health care staff who have tested positive)

Patients admitted to hospital with COVID-19 diagnosis

Have you received a positive COVID-19 diagnosis?
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 have an active diagnosis of COVID-19 using established testing.

Individuals will be excluded from the study if they have allergy to study interventions, epilepsy, serious hearing or visual problems, at risk of malignant arrhythmias, or are already receiving the study interventions.

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.

Study procedures

ACT COVID-19 study procedures includes taking study medication in combination with usual care, or the usual care alone. We will collect information on progress at 8-10 days after starting the trial, and again at 45 days and 12 months.

Usual Care: A term used to describe the full spectrum of patient care practices in which clinicians have the opportunity to individualize care based on patient needs.

Study Medication: May include various interventions or treatments, either separately or in combination.

  1. Outpatient trial – People in the community with a COVID-19 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.
  2. 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

Pre-Screening

  • Are you 18 years of age or older?
  • Do you have a diagnosis of COVID-19?

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 either:
    1. Study medications and usual care OR
    2. Usual care

Follow-up

  • 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: Once between Days 8-10
  • 2nd Follow-up: Day 45
  • 3rd Follow-up: 12 months

Study Sponsor

Hamilton Health Sciences through Population Health Research Institute

Leadership for the ACT COVID-19 study

Dr. Richard Whitlock
Dr. Emilie Belley-Côté
Dr. Salim Yusuf

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.

Contact

To determine if you qualify for ACT COVID-19 study,
please contact us:
By email at ACT@phri.ca, or by phone at 1-855-845-8868