Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI) (CCPSEI)
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|ClinicalTrials.gov Identifier: NCT04496466|
Recruitment Status : Enrolling by invitation
First Posted : August 3, 2020
Last Update Posted : July 27, 2021
This is a standardized protocol for the rapid, coordinated clinical investigation of severe or potentially severe acute infections by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Participants with acute illness suspected to be caused by SARS-CoV-2 (COVID-19) will be enrolled. This protocol has been designed to enable data and biological samples to be prospectively collected and shared rapidly in a globally-harmonized sampling schedule. Multiple independent studies can be easily aggregated, tabulated and analyzed across many different settings globally. The protocol is the product of many years of discussion among international investigators from a wide range of scientific and medical. Recruitment under this protocol has been initiated in response to Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV) in 2012-2013, Influenza H7N9 in 2013, viral hemorrhagic fever (Ebolavirus) in 2014, Monkeypox & MERS-coronavirus in 2018, Tick-borne encephalitis virus (TBEV) in 2019 and COVID-19 in 2020. Participants may be newly identified through healthcare system or public health access, under quarantine, or in isolation care in outpatient or inpatient settings relevant to the Johns Hopkins University School of Medicine. Other locations may adopt this study concurrently, under a deferred review, or cooperatively.
The existence of this protocol would ensure a timely, comprehensive epidemiologic and clinical characterization of the initial cases of COVID-19 in a mounting pandemic. The World Health Organization (WHO) recognized the need for standardized data collection for the epidemiology, immunology and clinical characteristics of these novel pathogens, and established the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) network in 2011. At the core of the protocol are a standardized schedule, structure and content of clinical, laboratory and microbiologic data collection, supplemented by domain-specific components (e.g., acute respiratory infection, viral hemorrhagic fever). The timepoints of this protocol will also be aligned with a separate multi-center institutional review board (IRB) approved protocol to describe patients with emerging infectious diseases that present to military treatment facilities within the United States.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)|
|Actual Study Start Date :||April 9, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||January 2023|
- Duration of viral shedding [ Time Frame: 3 months ]SARS-CoV-2 Reverse transcription polymerase chain reaction (RT-PCR) and viral culture will be performed on prospectively collected samples to determine presence and Ct of viral RNA and presence or absence of cultivable virus in assessing how long virus is shed (in days).
- Incidence of comorbidities [ Time Frame: 12 months ]Incidence of comorbidities (chronic kidney disease, lung disease, cardiovascular disease, venous thromboembolism) will be determined.
- Treatment response as assessed by survival [ Time Frame: 1 month ]Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.
- Treatment response as assessed by survival [ Time Frame: 3 months ]Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.
- Mortality of COVID-19 [ Time Frame: 12 months ]Survival rates overall will be determined in assessing the mortality of COVID-19.
- Change in lung ultrasound score [ Time Frame: Baseline and 1 month ]Changes in a lung ultrasound score (LUS) over time will be calculated and evaluated for prediction of disease severity defined by the World Health Organization COVID-19 ordinal scale (clinical status on an ordinal scale from 0 to 8 with higher scores meaning worse outcome).
- Change in immunoglobulin M (IgM) antibody levels in serum [ Time Frame: Baseline, one month, and every three months up to 12 months ]Change in IgM antibody levels in serum will be determined for description of host response.
- Change in immunoglobulin G (IgG) antibody levels in serum [ Time Frame: Baseline, one month, and every three months up to 12 months ]Change in IgG antibody levels in serum will be determined for description of host response.
- Change in immunoglobulin A (IgA) antibody levels in serum [ Time Frame: Baseline, one month, and every three months up to 12 months ]Change in IgA antibody levels in serum will be determined for description of host response.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496466
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21217|
|Principal Investigator:||Lauren Sauer, MS||Johns Hopkins University|