Novel Coronavirus (2019-nCoV) technical guidance: Early investigations
Early investigations are critical to carry out early in an outbreak of a new virus.
The data collected from the study protocols provided here can be used to refine recommendations for surveillance and case definitions, to characterize the key epidemiological transmission features of 2019-nCoV, help understand spread, severity, spectrum of disease, impact on the community and to inform operational models for implementation of countermeasures such as case isolation, contact tracing and isolation.
Protocol for assessment of potential risk factors for 2019-novel coronavirus (2019-nCoV) infection among health care workers in a health care setting
The extent of 2019-nCoV infection in health care settings is not clear, nor whether there are certain risk factors associated with infection in health care workers. The following protocol has been designed to investigate the extent of infection and risk factors for infection among health care workers. Follow-up and testing of respiratory specimens and serum of health care workers within a facility in which a confirmed case of 2019-nCoV infection is receiving care can provide useful information on transmissibility and routes of transmission, and are important for limiting amplification events in health care facilities.
- Access the assessment protocol
For more information, please contact: EarlyInvestigations-2019-nCoV@who.int.
Household transmission investigation protocol for 2019-novel coronavirus (2019-nCoV) infection
The household transmission investigation is a case-ascertained prospective study of all identified household contacts of a laboratory confirmed 2019-nCoV infection. It is intended to provide rapid and early information on the clinical, epidemiological and virological characteristics of 2019-nCoV.
- Access the investigation protocol
For more information, please contact: EarlyInvestigations-2019-nCoV@who.int.
The following protocol has been designed to investigate the First Few X cases (FFX) and their close contacts. It is envisioned that the FFX 2019-nCoV investigation will be conducted across several countries or sites with geographical and demographical diversity. Using a standardized protocol such as the protocol provided here, epidemiological exposure data and biological samples can be systematically collected and shared rapidly in a format that can be easily aggregated, tabulated and analyzed across many different settings globally for timely estimates of 2019-nCoV infection severity and transmissibility, as well as to inform public health responses and policy decisions. This is particularly important in the context of a novel respiratory pathogen, such as 2019-nCoV.
- Access the investigation protocol
For more information, please contact: EarlyInvestigations-2019-nCoV@who.int.
Global 2019-nCoV Clinical Characterization Case Record Form
This case record form (CRF) is intended to provide member states with a standardized approach to collect clinical data in order to better understand the natural history of disease and describe clinical phenotypes and treatment interventions (i.e. clinical characterization). By using one standardized clinical data tool, there is potential for clinical data from around the world to be aggregated; in order to learn more to inform the public health response and prepare for large scale clinical trials.
For more information, please contact: EarlyInvestigations-2019-nCoV@who.int.
WHO launches new data platform for anonymized 2019-nCoV clinical data
In response to the 2019 novel coronavirus (2019-nCoV) epidemic, the World Health Organization (WHO) is launching a global 2019-nCoV Anonymized Clinical Data Platform (the “nCoV Data Platform”) to enable State Parties to the International Health Regulations (IHR) (2005) to share with WHO anonymized clinical data and information related to patients with suspected or confirmed infections with the 2019-nCoV (collectively “Anonymized nCoV Data”).
The Anonymized nCoV Data received from State Parties through the nCoV Data Platform will remain property of the contributing State Party, and will be used by WHO for purposes of verification, assessment and assistance pursuant to the IHR (2005), including to inform the public health and clinical operation response in connection with the 2019-nCoV outbreak.
To help achieve such purposes, WHO will establish an independent Clinical Advisory Group to advise WHO on global reporting and analysis of the Anonymized nCoV Data.
State Parties are invited to contribute Anonymized nCoV Data to the nCoV Data Platform. State Parties should please contact WHO at EDCARN@who.int to obtain more information about, including log-in credentials for, the nCoV Platform.
To preserve the security and confidentiality of the Anonymized nCoV Data, State Parties are respectfully requested to take all necessary measures to protect their respective log-in credentials and passwords to the nCoV Data Platform.
The Anonymized nCoV Data will be stored in the nCoV Data Platform, which is a secured, access-limited, password protected electronic platform that is hosted on behalf of WHO by a third-party platform provider. WHO and such party have entered into contractual arrangements requiring the latter, among other things: (i) to protect the confidentiality and prevent the unauthorized disclosure of the Anonymized nCoV Data; (ii) to refrain from using the Anonymized nCoV Data for any purpose other than providing hosting services to WHO in accordance with the contractual arrangements; and (ii) to implement and maintain appropriate technical and organizational security measures to protect the security of the Anonymized nCoV Data and the nCoV Data Platform.
In accordance with Article 11(4) of the IHR (2005), WHO will not make the Anonymized 2019-nCoV Data generally available to other State Parties until such time as any of the conditions set forth in paragraph 2 of such Article 11 are first met, and following consultation with affected countries.
Pursuant to that same Article 11, WHO will not make Anonymized 2019-nCoV Data available to the public, unless and until Anonymized 2019-nCoV Data has already been made available to State Parties, and provided that other information about the 2019-nCoV epidemic has already become publicly available and there is a need for the dissemination of authoritative and independent information.
For more information, please contact: EarlyInvestigations-2019-nCoV@who.int.