C3PO 4 September 2020

C3PO 4 September 2020

Site Progress 41 Sites have Advarra approval 36 Sites have completed their readiness call 29 executed contracts 22 Released to Enroll 14 sites Screening 14 Enrolled

29 Sites With Executed Contracts Name Ben Taub General Hospital, Houston, TX Cedars-Sinai Medical Center, Los Angeles, CA Detroit Receiving Hospital, Detroit, MI Grady Memorial Hospital, Atlanta, GA Harbor-UCLA Medical Center, Torrance, CA Harper University Hospital, Detroit, MI HealthPartners Methodist Hospital, St. Louis Park, MN Henry Ford Hospital, Detroit, MI Jackson Memorial Hospital, Miami, FL Memorial Hermann Texas Medical Center, Houston, TX Oregon Health & Science University Hospital, Portland, OR OSU Wexner Medical Center, Columbus, OH Regions Hospital, St Paul, MN Sinai-Grace Hospital, Detroit, MI Spectrum Health Hospitals Butterworth Hospital, Grand Rapids, MI Stanford University Medical Center, Stanford, CA Temple University Hospital, Philadelphia, PA UCSD Medical Center - Hillcrest Hospital, San Diego, CA UF Health Shands Hospital, Gainesville, FL University of Colorado Hospital, Aurora, CO Wake Forest Baptist Medical Center, Winston-Salem, NC Duke University Hospital, Durham, NC Froedtert Hospital, Milwaukee, WI Maine Medical Center, Portland, ME Parkland Hospital, Dallas, TX Ronald Reagan UCLA Medical Center, Los Angeles, CA University of Utah Healthcare, Salt Lake City, UT UF Health Jacksonville, Jacksonville, FL UPMC Presbyterian Hospital, Pittsburgh, PA Status Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Ready to receive investigational product Ready to receive investigational product Ready to receive investigational product Ready to receive investigational product Ready to receive investigational product Ready to receive investigational product Preparing - High Priority Preparing - High Priority

22 Sites Released To Enroll Hub Site 1st Subject In Ben Taub Ben Taub General Hospital, Houston, TX Cedars-Sinai Cedars-Sinai Medical Center, Los Angeles, CA Emory Grady Memorial Hospital, Atlanta, GA Florida Jackson Memorial Hospital, Miami, FL 26-Aug-20 Florida UF Health Shands Hospital, Gainesville, FL 11-Aug-20 HFHS Henry Ford Hospital, Detroit, MI OHSU Oregon Health & Science University Hospital, Portland, OR OSU OSU Wexner Medical Center, Columbus, OH Regions HealthPartners Methodist Hospital, St. Louis Park, MN Regions Regions Hospital, St Paul, MN Stanford Stanford University Medical Center, Stanford, CA Temple Cooper University Hospital, Camden, NJ Temple Temple University Hospital, Philadelphia, PA Texas Memorial Hermann Texas Medical Center, Houston, TX UCLA Harbor-UCLA Medical Center, Torrance, CA UColorado University of Colorado Hospital, Aurora, CO UCSD UCSD Medical Center - Hillcrest Hospital, San Diego, CA Wake Wake Forest Baptist Medical Center, Winston-Salem, NC Wayne Detroit Receiving Hospital, Detroit, MI Wayne Harper University Hospital, Detroit, MI Wayne Sinai-Grace Hospital, Detroit, MI Wayne Spectrum Health Hospitals Butterworth Hospital, Grand Rapids, MI 26-Aug-20 22-Aug-20 19-Aug-20 24-Aug-20

Screening Logs 14 Enrolled 86 Screen Failures 6 had Consent Obtained, but not enrolled (2 got impatient before test results came back; 3 had exclusion criteria discovered) 17 Declined Study 52 Do not meet Inclusion 13 with various (5 missing Spanish Consent form , 5 study team not available) Fixed Help!

2-3 enrollments / site / week

Site Progress 41 Sites have Advarra approval 36 Sites have completed their readiness call 29 executed contracts 22 Released to Enroll 14 sites Screening 14 Enrolled 2-3 enrollments / site / week x 50 sites 100150 / week

Wish we started July 1 Wish we had 50 sites active

Things to do right now 1. Clinical team training – Has to be done, but not hard 2. Any other people will be added to DOA? - Get their research / training certificates now 3. EPIC / CERNER / EMR builds - Pharmacy approval for placebo 4. Blood Bank programming and SOPs – Talk to them now 5. Committees – “one more approval” – Use Francis Collins’ letter 6. Any special IRB language? - Put it in WebDCU Now. 7. Readiness call – Schedule it Now

You cannot change the IRB – Approved Consent Form! Your institution and local IRB can add “special things” in a box after the form (but this has to be approved by the central IRB). “Special things” go into WebDCU – find out if any and put them in NOW! https://siren.network/clinical-trials/c3po/getting-started Consent Form (Updated 7-10-20) C3PO e.consent Use this training link for your practice and training needs. If you provide your email address at the end of the consent you will receive an email like the one a study participant would receive. The email to the participant reflects the email local study team members (on the e.DOA with consenting permissions) will receive when a real participant is enrolled. A site specific participant link, unique to your site and mirroring the cIRB-approved paper version of the site consent will be provided nearer to the time that your site is released to enroll. To learn more: SIREN e.consent SOP