Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)

Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and SARS CoV-2, novel influenza viruses, viruses causing viral hemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking.

In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility.

The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to almost 500,000 cases of COVID-19 and over 22,000 deaths worldwide. There have been 24,738 cases and 291 deaths in the United states and 190 cases in Maryland, USA as of March 21, 2020. The global is dire, with reports of severe overcrowding in hospitals, shortages of medical supplies, and insufficient medical personnel to address the surge in patients seeking care. The risk of this situation occurring in other countries is highlighted by the propensity for high infectiousness and asymptomatic spread. To protect patients and the community-at-large, research is urgently needed to guide quarantine and treatment strategies for COVID-19.

Morbidity and mortality from COVID-19 is associated with the development of fulminant respiratory failure. Recent data suggests death rates as high as 38% among those requiring ICU care, many of whom developed Acute Respiratory Distress Syndrome (ARDS). However, it is currently unknown which patients are at risk of severe disease. Diagnostic tools are urgently needed to detect immunologic and physiologic disease responses to identify infection in asymptomatic individuals and to identify infections on the trajectory to ARDS. Furthermore, the infectious reservoirs of SARS CoV-2 remain unclear although children may be important reservoirs given children's relatively mild disease course as well as prolonged viral shedding from both respiratory and stool specimens. This protocol aims to address these critical knowledge gaps and future questions relevant to COVID-19 clinical management.

INPATIENT Enrolled inpatient individuals will have whole blood, 1 RNA tube, serum, nasopharyngeal (NP) or oropharyngeal (OP) swabs collected at enrollment. Subsequent blood (whole blood, serum, or plasma) collections solely for research among hospitalized patients will be a maximum of 10 mL per day. This will generally follow a schedule of day 0/1, 3, 7 and weekly while hospitalized. Subsequent collections after hospital discharge occur at 1 month, 3 months, 6 months, 9 months, and 12 months.