Master Protocol
CTO Provincial Amendment 4 – Recruitment Materials- Approval – Feb 24 2023
CTO Provincial Amendment 3 – Follow ups and online self-screening form – Approval – Jan 18 2023
CTO Provincial Amendment 2 – Aligning Versions with Health Canada – Approval – Dec 2 2022
CTO Provincial Initial Application Approval – Oct 11, 2022
CanTreatCOVID – Master Protocol – Oct 28 2022 Clean
CanTreatCOVID – Master Protocol – Oct 28 2022 Tracked Changes
CanTreatCOVID – Master Linking LOG and Contact Info – ON – V1.1 – Jan 17 2023
Appendix 1 – Master Linking Log and contact info – Sep 9 2022 Clean
Appendix 2 – Information sheet and consent – Oct 13 2022 Clean
Appendix 2.1 – ICF witness attestation form – Sept 29 2022
Appendix 3.1 – Demographic data – Sept 29 2022 Clean
Appendix 3.2 – Baseline data – Oct 13 2022 Clean
Appendix 3.3 – Follow-up at 21 days – Dec 9 2022 Clean
Appendix 3.4 – Follow-up at 28 days – Dec 9 2022 Clean
Appendix 3.5 – Follow-up at 90 days – Dec 9 2022 Clean
Appendix 3.6 – Follow-up at 36 weeks – Dec 9 2022 Clean
Appendix 3.7a – Daily diary – Oct 13 2022 Clean
Appendix 3.7b – Daily diary (Flu Pro Plus) – Oct 13 2022
Appendix 3.8 – Follow-up at day 1 – Oct 13 2022 Clean
Appendix 3.9 – End of treatment or study – Oct 13 2022 Clean
Appendix 4.1 – Initial contact script and Screening Form – Sept 9 2022
Appendix 4.2- Pharmacist Script and Pharmacy Form – Sept 9 2022
Appendix 4.3 – Recruitment Poster – February 14 2023 – Clean
Appendix 4.3a – Social Media Posts and Accounts – January 13 2023 Clean
Appendix 4.3b – Recruitment Poster 2 – February 9 2023
Appendix 4.3g – Email to companies – January 13 2023 (see note below about email of support from the institution)
Appendix 4.3h – Recruitment email – January 13 2023
Appendix 4.3i – Outreach from Workplace Health COVID-19 Team – January 13 2023
Appendix 4.3j – Recruitment video script – January 13 2023
Appendix 4.3k – Recruitment Poster 3 – February 14 2023
Appendix 4.4 – Letter to PBRN associated providers – Nov 3 2022 Clean
Appendix 4.5 – Letter to PBRN associated patients from providers – Nov 3 2022 Clean
Appendix 4.6 – Letter to providers after patient enrollment – Nov 3 2022 Clean
Appendix 4.7 – Online self-screening form – EN and FR – Jan 5 2023
Appendix 5 – DSMC charter – July 27 2022
Appendix 6.1 – ISA usual care – Aug 1 2022
Appendix 7.1 – Study co-investigators – Oct 13 2022 Clean
Appendix 7.2 – Committee members – Sept 9 2022
Appendix 8 – Adverse Event Log – Sept 9 2022
Appendix 9 – Medication Log – Sept 9 2022
Appendix 10 – Amendment tracker – Oct 28 2022 Clean
Appendix 10 – Amendment tracker – Oct 28 2022 Tracked Changes
Appendix 11 – Protocol Deviation Log – Sept 29 2022
Appendix 12 – Toll-free phone line contacts – Sep 29 2022
Provincial Amendment 2 Request Letter – Nov 15 2022
Note: Appendix 4.3j – Recruitment video script – January 13 2023 requires a letter of support from that institution before distribution. This can be provided in emails of support that can be submitted to this REB as they are enlisted. Furthermore, some of these institutions may need to confirm internally if REB approval is required to recruit at those sites and if applicable can be obtained separately or as a centre within CTO via CIA – it is the responsibility of these institutions to verify this.
Please email Celine at celine.jeanxavier@utoronto.ca to let her know that you have read and understood those requirements and that you will follow them.
Paxlovid x 5 Days
Paxlovid x 5 days – Appendix 5 – Product Monogram – Jun 13 2022
Paxlovid x 5 Days Sub-Protocol – Oct 28 2022 Clean
Paxlovid x 5 Days Sub-Protocol – Oct 28 2022 Tracked Changes
Paxlovid x 5 Days – Appendix 1 – Information sheet and consent – Oct 13 2022 Clean
Paxlovid x 5 days – Appendix 2 – Initial Contact Script and Screening Form – Oct 13 2022 Clean
Paxlovid x 5 Days – Appendix 3 – Participant Information Sheet – Oct 13 2022
Paxlovid x 5 Days – Appendix 4 – Wallet Contact Card – Oct 13 2022
Paxlovid x 5 Days – Appendix 5.1 – Summary of Product Characteristics for Paxlovid – Jan 11 2022
Paxlovid x 5 days – Appendix 5.2 – Drugs that Require Adjustment when Co-Administered – Oct 13 2022
Paxlovid x 5 Days – Appendix 5.3 – What Prescribers and Pharmacists Need to Know – Dec 2022
Paxlovid x 5 Days – Appendix 5.4 – Paxlovid Drug-Drug Interactions – Oct 13 2022
Paxlovid x 5 Days – Appendix 6 – Follow-up at Day 4 – Oct 13 2022
Unity Health Toronto – St. Michael’s Hospital
Manuals, Instructions, SOPs
Recruitment Materials
The recruitment posters and social media graphics were created on Canva, an online design website.
To access the editable versions of the materials:
- Create a free account on Canva
- Click the design links below
- Create a copy of the design for your hub before editing. Do not edit the original files. To duplicate the designs,
- Open the design you want to duplicate.
- Click File from the status bar above the editor.
- Click Make a copy. The duplicated design will open in a new tab.
Links to designs
- Recruitment posters (8.5 x 11 in) – Feb 2023
- 3 poster designs for participants
- 1 poster design for service providers
- Recruitment posters (8.5 x 14 in with tear off pieces) – Feb 2023
- Recruitment posters (24 x 36 in) – Feb 2023
- Stickers – Feb 2023
- Magnets – May 2023
- Business Card (3.5 x 2 in) – Feb 2023
Recruitment toolkit: https://cantreatcovid.org/recruitment-toolkit/
Training Materials
Site Initiation Visit – Ontario
Protocol Training Video
Study Conduct and Database Training
CanTreatCOVID Protocol Training – SIV ON – Jan 12 2023 (presentation slides)
CanTreatCOVID Study Operations – SIV ON – Jan 12 2023 (presentation slides)
Database Demonstration
Key Messages
We have developed these key messages for all investigators, staff and trainees involved in CanTreatCOVID. Please use this to support awareness of the study and our findings.
- We are evaluating the effectiveness of existing and emerging treatments for acute COVID-19 in primary care and community settings. Importantly, our study will go beyond nirmatrelvir/ritonavir (Paxlovid).
- We are also studying whether any acute treatment can prevent long COVID.
- We are building our adaptive platform trial to be useful for other respiratory infections and help with future pandemics.
