A5401: Outpatient Monoclonal Antibodies and Other Therapies


Activ-ated Sites:



Wash U

Uni of Washington

UNC Chapel Hill


Site Activation Tips

The ACTIV-2 team has identified some best practices on site activation to help your site successfully navigate the process. Please proactively tell us about any issues you are facing / expect to face. The earlier you flag issues to us, the more we can support you.

  • During the qualification process, let us know if you are interested in participating but lack facilities and / or materials
    • We will provide support where possible, but need you to proactively tell us your needs
  • During your PSV / SIV, please proactively flag any gaps in facilities, supplies, staff, logistics support, or any other issues. Common issues that others have encountered include:
    • Facilities: Lack of space to conduct infusion, lack of biosafety cabinets
      • Try to secure enough space to conduct more than 1 infusion / day
    • Supplies/equipment: Lack of IV pump, pulse oximeter, diagnostics (e.g. point of care testing)
    • Staff: Lack of pharmacy staff
    • Logistics challenges (e.g. shipping)
  • We can support sites in creating or augmenting infusion capacity through trailers and tents
  • Once your site is qualified, please provide your Site Information Sheet (SIS) to the PPD Country Approval Specialist (CAS) within 24 hrs and share your local IRB process (if any)
  • Submit site regulatory documents to PPD CAS within 2 days of receipt
  • Avoid changes to regulatory documents that trigger resubmission for IRB approval

Recruitment Tips

The ACTIV-2 team has compiled some emerging best practices on participant recruitment to help your site. Contact us for support across any of these initiatives:

  • Let us know if testing turnaround time is slow (>48 hours) at your site / in your locality!
    • We have 3 diagnostic support options to accelerate turnaround timing.
  • Establish relationships with your local health department and testing sites so that COVID-positive patients are referred to your site for the study.
  • Try to provide flexible hours to participants for infusions; offer infusions post 5pm on weekdays and on weekends.
  • Strong PI involvement is appreciated by participants and drives increased enrollment (e.g. talking participants through the consent).
  • Designate someone within your site who’s good at infusions and line placements
  • Apply for a HIPAA waiver through your IRB so that you can contact COVID-positive patients and enroll them in study

Best Practices Playbook

We are in the process of compiling a best practices playbook that will be accessible to all sites on the PSWP soon! This will be a one-stop resource for tips on site activation and recruitment, and we will update it regularly as the study progresses.

Join the Site Call Every Thursday

At 5P ET every Thursday get together with the study team and other sites to get the latest info about the trial and learn what other sites are doing.

Recruitment Materials on the PSWP

A growing toolbox of recruitment materials can be found on the PSWP. These include a pocket card with a QR link to the study website, a FAQs info-sheet, and templates that can be used for posting about the study on social media. Soon we will add copy for local newspaper ads, a study brochure, posters, and other materials that sites can use to promote the study. These will also be downloadable from the website.

Check Out the ACTIV-2 Study Website:

The ACTIV-2 website provides loads of info about COVID-19, clinical trials, and the study protocol. There is a direct link on the website to our Contact Center where operators are available 24/7 to help determine if a caller is eligible for the trial and, if so, connect them to a nearby site. Both the website and the Contact Center are available in English and Spanish.

New Communications Campaign to Drive Enrollment

We’re working with communications partners on an exciting new campaign to inform potential participants about the trial and inspire them to enroll, with an intense focus on diverse communities.  You’ll begin to see this campaign digitally in your communities as sites get up and running.  We’re also working with our partners to provide resources directly to trial sites, such as brochures and print materials, featuring the new call to action for participants:  Rise Above COVID. Soon, will link to our site.

Alert the Media!

The PSWP also has a Press Release Template that sites can tailor to include quotes from local investigators. Use it when you enroll your first participant so that the world can know that you are part of this historic clinical trial.