8 Dec 2012
In light of the recent WHO update on the Novel Coronavirus [30 Nov 2012], and given the paucity of evidence on which to base treatment and understand disease pathogenesis, ISARIC -- a recently formed global clinical research consortium -- would like to propose a collaborative clinical research platform.
The proposed studies aim to assess prospectively the pathogenesis of illness and potential therapeutic interventions for patients infected with the novel coronavirus (nCoV). Standardized collection of data will facilitate sharing of information among those caring for such patients. The proposals from ISARIC would be open and available to any organization interested in participating.
Though the total number of laboratory confirmed cases to date is low, it is impossible to know how many cases may occur. In addition the patients may be admitted in future to multiple hospitals in many different countries. It is crucial to plan for standardized, prospective data collection in order to understand how to improve the clinical outcome for patients with nCoV.
The following suggestions also cover specific therapeutic interventions, which we believe need to be evaluated. These interventions do not include studies on supportive care such as access to critical care, fluid management and organ support as established guidelines, including those of WHO, are available for these.
ISARIC proposed studies
Observational studies should be conducted in the situation of a novel disease, which may occur in a variety of resource settings, and may be the only pragmatic option for data collection available. Clinicians should include data collection on all therapeutic interventions delivered.
Prospective, sequential, standardized clinical data collection and daily sampling for virological and pathogenesis studies should be undertaken, whenever feasible, and with strict adherence to appropriate infection control measures. Where possible we recommend that these clinical samples should be stored, with consent, for future research.