An evidence-based framework for priority clinical research questions for COVID-19

Abstract

Background 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 75,000 cases globally of the 2019 novel coronavirus (COVID-19), 2000 deaths, and over 14,000 cases recovered. 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 COVID-19 and provide an evidenced-based framework for priority clinical research in the current outbreak.

Methods 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 February 2020, available information on COVID19 was reviewed and compared to the results of the SARS-CoV and MERS-CoV systematic review.

Results 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 COVID19, some information on clinical presentation, diagnostic testing, and aetiology is available but many clinical research gaps have yet to be filled.

Conclusions Based on a systematic review of other severe coronaviruses, we summarise the state of clinical research for COVID-19, 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.
On 31 December 2019, the World Health Organization China Country Office was informed of cases of pneumonia of unknown etiology detected in Wuhan City, China. Shortly after, the National Health Commission China reported that the outbreak was associated with exposures in a seafood market in Wuhan. Chinese authorities then isolated and identified a novel coronavirus and shared the genetic sequence on 12 January 2020 [1]. Phylogenetic analysis showed that the novel virus falls into the betacoronavirus family, with about 86% similarity to a bat SARS-like coronavirus [2]. Human-to-human transmission of the virus has been confirmed [3]. As of 18 February 2020, there have been 75,161 cases in 29 countries with 2,008 deaths. Currently, the disease caused by 2019 novel coronavirus has been referred to as COVID-19, and the virus SARS-CoV-2.
Outbreaks, especially of novel agents, create a pressing need to collect data on clinical characterization, treatment, and validation of new diagnostics to inform rapid public health response. In 2018, we conducted a systematic review to identify the most common clinical research questions asked during outbreaks of SARS-CoV and MERS-CoV. We identified ten major clinical questions and provided recommendations for standardised protocol study designs that should be designed in the case of a new outbreak of a novel respiratory pathogen. Here, we review the currently available information on COVID-19 to determine which clinical questions from the systematic review findings have already been addressed, what information is lacking, and compare COVID-19 to SARS-CoV and MERS-CoV.

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This work is licensed under a Creative Commons Attribution 4.0 International License. https://creativecommons.org/licenses/by/4.0/

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https://doi.org/10.7189/jogh.10.011001

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https://www.research.ed.ac.uk/portal/en/publications/an-evidencebased-framework-for-priority-clinical-research-questions-for-covid19(545d8a42-5c48-4170-b607-7af8fd8235c8).html