Development of Medical Countermeasures to Middle East Respiratory Syndrome Coronavirus

Timothy M. Uyeki; Karl J. Erlandson; George Korch; Michael O'Hara; Michael Wathen; Jean Hu-Primmer; Sally Hojvat; Erik J. Stemmy; Armen Donabedian

Disclosures

Emerging Infectious Diseases. 2016;22(7):e1-e11. 

In This Article

Clinical Experience and Medical Countermeasure Trials

The overarching goal for clinical research of MERS-CoV patients is to optimize clinical management and to identify effective therapies to improve survival. Although clinical data on some MERS-CoV patients have been published in case series,[58,78,79] there is a need for much more epidemiologic, clinical, virologic, and immunologic data to improve the limited understanding of the pathogenesis of MERS-CoV infection in humans. Gaps include information on viral load and duration of viral shedding in blood, urine, respiratory, and other clinical specimens from infected persons; understanding of the innate and adaptive immune response to MERS-CoV infection; pathology data on the distribution of MERS-CoV in respiratory and extrapulmonary tissues in fatal cases; information from autopsies of persons who died of MERS-CoV; and an overall improved understanding of the pathogenesis of MERS-CoV in humans. Only one study has investigated MERS-CoV infection in autopsy tissues of a patient who died from the disease.[80] Collaborations are especially needed to pool and systematically collect serial clinical specimens from MERS-CoV patients for virologic, immunologic, and biomarker analyses to correlate with clinical illness, and to conduct long-term follow-up of survivors of severe disease.[81–83] Detailed understanding of host factors and cofactors associated with disease severity from asymptomatic infection to fatal illness is needed. Efforts to promote international sharing of clinical specimens and MERS-CoV isolates are needed to foster development of diagnostics, therapeutics and vaccines.

Use of standardized clinical data collection instruments and common biologic sampling protocols for serial prospective data collection will facilitate data pooling from MERS-CoV cases and comparisons across clinical sites and countries. Global collaborations among clinical networks are also needed to implement clinical trials, preferably randomized controlled clinical trials, of MERS-CoV investigational therapeutics,.[81–84] Without an international agreement on protocols and systematic standardization of case reporting and data collection methods, haphazard or anecdotal reporting and analysis of disease course and outcome may continue. WHO and the International Severe Acute Respiratory and Emerging Infection Consortium are collaborating in adapting standardized protocols for controlled clinical trials for MERS-CoV.[82]

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