Purpose of the Study
This standardised protocol can be used for the rapid, coordinated clinical investigation of confirmed cases of COVID-19.
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 COVID-19 in 2020.
The protocol is free to use and investigators retain full control of all data and samples. ISARIC offers a web-based eCRF for the CCP and can host the data. For information on the eCRF please contact firstname.lastname@example.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.
We ask that ISARIC is acknowledged and informed if you implement the protocol. Ethical approval of the protocol and all necessary operational and financial arrangements are the responsibility of the investigators.
NEW: ISARIC/WHO Clinical Characterisation Protocol (CCP)
Please find all the available resources here.
You may download and adapt to your research.
All the documents available on the link above 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).
The protocol was prepared by School of Public Health, The University of Hong Kong, Hong Kong (Leo Poon, Daniel Chu and Malik Peiris). Enquiries: please contact Leo Poon (email@example.com) or Malik Peiris (firstname.lastname@example.org)
Detection of 2019 novel coronavirus (COVID-19) by real-time RT-PCR Corman et al, Eurosurveillance
A list of downloable documents is available below along with a tier sample table.