GenOMICC UK Virtual Site Visit

COVID-19 is a key aim of GenOMICC

Susceptibility to COVID-19 is almost certainly, in part, genetic. GenOMICC can find the genes that cause susceptibility, which may help us to prioritise treatments to respond to the global crisis. GenOMICC was designed for this crisis. Since 2016, the open, global GenOMICC collaboration has been recruit patients with emerging infections, including COVID-19. All critically-ill patients with confirmed COVID-19 are eligible for GenOMICC. Please recruit them as normal, following local infection control precautions.

GenOMICC is prioritised as an NIHR Urgent Public Health Study in the UK

In the UK, recruitment to GenOMICC will supplement other studies (e.g. ISARIC 4C, RECOVERY, and REMAP-CAP), enabling faster answers. We will co-enrol and combine samples. Telephone consent is allowed, or witnessed consent forms (from outside the PPE area) can be used to record consent.

Thanks for obtaining approval to recruit to the GenOMICC study! This virtual site visit describes the key next steps you need to take in order to get started with recruitment.

Before you start, you should:

  • be appropriately trained to conduct clinical research in patients in your clinical area and legal system
  • have ethics and R&D approval for GenOMICC
  • have access to the REDCap CRF at redcap.clinicaltrials.ed.ac.uk

Site file

You will need to create a GCP-compliant site file and store it in a secure location accessible only to trained staff working on the study. The site file should contain:

  1. Study Documents
    • Current
    • Superseded
  2. Approvals
    • Ethics
    • R&D
    • Amendments
    • Contracts
    • OID
  3. Research Team
  4. Safety
    • Safety reporting
    • Protocol Violations
    • Protocol Deviations
  5. Participant Documents
    • Consent form

Sample collection kits

The GenOMICC team will supply you with specimen transport kits, containing:

  • Sticky labels for each patient
  • Sample bag and absorbent material
  • Pre-addressed specimen boxes for postage

Recruitment procedure

  1. Obtain consent

  2. Obtain blood sample according to the patient's weight (>40kg: 9mls; 20 to 40kg: 7mls; 10 to 20kg: 4mls). Blood can be obtained in any EDTA blood tubes. Depending on what system is used in your hospital, you will probably have to send us several tubes. Try to get as close as you can to the required volume, because this gives us the best chance of getting high-quality DNA.

  3. Take all four of the of GenOMICC sample stickers from inside one of the return GenOMICC specimen boxes that we have sent to you.

  4. Use the stickers to label the consent form and the blood tubes. Destroy any unused stickers.

  5. Store consent form in local site file.

  6. Put blood tubes in the plastic bag with absorbent material, seal and package into the GenOMICC postage - paid specimen box and return to the Wellcome Trust Clinical Reseach Facility (WTCRF), Edinburgh as soon as possible.

  7. Complete RedCap CRF, including:

    • Clinical and demographic details
    • Positive microbiology (when available)
    • 60 day outcome (when available)
  8. For patients lacking capacity - plan a review date to assess for regained capacity.

Example blood tubes to use for a patient >40kg in weight.

System Tube size Number of tubes Total volume
Monovette 2.7ml 3 8.1ml
Monovette 9ml 1 9ml
Vacutainer 2ml 4 8ml
Any EDTA blood tube any size <=9ml