ISARIC/WHO Clinical Characterisation Protocol (CCP)

This protocol is for worldwide investigators. For recruitment in UK please see here.

If you wish to find out more about ISARIC’s 2019 nCoV resources please visit the nCoV resource page.

These documents can also be viewed at this Dropbox link.

If you are an interested in using or developing these protocols for global use, please join the slack group for the ISARIC CCP Investigators Group (Chair - JK Baillie, University of Edinburgh).

Move the slider or enter a priority level to see the flexibility in the sampling schedule.

Recruitment Week 1 Week 2 Further samples Convalescent samples
Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Weekly until max 100 days
3 & 6 months
after recruitment
>40kg R P S P S P S P S P S P S P S S C
20 to 40kg R P S P S P S P S P S P S P S S C
10 to 20kg R P S P S P S P S P S P S P S S C
4 to 10kg R P S P S P P P S P P P S P P S C
<4kg R P S P S P P P S P P P S P P S C
Sample priority 1 11 2 11 5 11 7 11 3 11 8 11 10 11 9 6 4

Sampling pattern - In Patient Recruitment. R = recruitment samples. S = serial samples including pathogen samples; P = research pathogen samples only; C = convalescent samples (see Table 3). *Resolution of acute illness is defined in section 3.7. In the event that local resource limitations require sampling frequency to decrease, samples will be prioritised as shown (1=highest priority).

This standardised protocol can be used for the rapid, coordinated clinical investigation of confirmed cases of 2019-nCoV.

The Clinical Characterisation Protocol (CCP) is designed for any severe or potentially severe acute infection of public health interest. The protocol enables data and biological samples to be collected rapidly in a globally-harmonised manner.

The protocol is the product of many years of discussion among international investigators from a wide range of scientific and medical disciplines (Lancet ID 14(1):8; https://doi.org/10.1016/S1473-3099(13)70327-X).

Recruitment under this protocol has previously been initiated in response to Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV) in 2012-2013, Influenza H7N9 in 2013, viral haemorrhagic fever (Ebolavirus) in 2014, Monkeypox & MERS-CoV in 2018, Tick-borne encephalitis virus (TBEV) in 2019 and 2019-nCoV in 2020.

The protocol is free to use and investigators retain full control of all data and samples. To help investigators recruit quickly, ISARIC offers a web-based eCRF for the CCP and can host the data. For information on the eCRF please contact ncov@isaric.org. You will retain full ownership and access to your data and it will not be used or shared in any way without your permission.