[Source: Lancet Preprints, full page: (LINK). Abstract, edited.]
An Evidence-Based Framework for Priority Clinical Research Questions for 2019-nCoV
22 Pages Posted: 4 Feb 2020
Carlyn Harris, Emory University – School of Medicine; Gail Carson, University of Oxford – Centre for Tropical Medicine and Global Health; Peter Horby, University of Oxford – Centre for Tropical Medicine and Global Health; Harish Nair, University of Edinburgh – College of Medicine & Veterinary Medicine
On 31 December, 2019, the World Health Organization China Country Office was informed of cases of pneumonia of unknown aetiology. Since then, there have been over 4000 cases globally of the 2019 novel coronavirus (n-CoV) and over 100 deaths. Outbreaks of novel agents represent opportunities for clinical research to inform real-time public health action. In 2018, we conducted a systematic review to identify priority research questions for Severe Acute Respiratory Syndrome-related coronavirus (SARS-CoV) and Middle East Respiratory Syndrome-related coronavirus (MERS-CoV). Here, we review information available on 2019 n-CoV and provide an evidenced-based framework for priority clinical research in the 2019 n-CoV outbreak.
Three bibliographic databases were searched to identify clinical studies published on SARS-CoV and MERS-CoV in the outbreak setting. Studies were grouped thematically according to clinical research questions addressed. In January 2020, available information on 2019 n-CoV was reviewed and compared to the results of the SARS-CoV and MERS-CoV systematic review.
From the research objectives for SARS-CoV and MERS-CoV, ten themes in the literature were identified: Clinical characterisation, prognosis, diagnosis, clinical management, viral pathogenesis, epidemiological characterisation, infection prevention and control/transmission, susceptibility, psychosocial, and aetiology. For 2019 n-CoV, some information on clinical presentation, diagnostic testing, and aetiology is available but many clinical research gaps have yet to be filled.
Based on a systematic review of other severe coronaviruses, we summarise the state of clinical research for 2019 n-CoV, highlight the research gaps, and provide recommendations for the implementation of standardised protocols. Data based on internationally standardised protocols will inform clinical practice real-time.
Funding: No funding to disclose.
Declaration of Interest: All authors declare no competing interests. GC and PH are involved in the operation of ISARIC.
Keywords: coronavirus; outbreaks; clinical research; nCoV; pandemics; SARS; MERS
Suggested Citation: Harris, Carlyn and Carson, Gail and Horby, Peter and Nair, Harish, An Evidence-Based Framework for Priority Clinical Research Questions for 2019-nCoV (1/29/2020). Available at SSRN: https://ssrn.com/abstract=3529457