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Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI) (CCPSEI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04496466
Recruitment Status : Enrolling by invitation
First Posted : August 3, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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
Coronavirus

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Incidence of comorbidities [ Time Frame: 12 months ]
    Incidence of comorbidities (chronic kidney disease, lung disease, cardiovascular disease, venous thromboembolism) will be determined.

  2. 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.

  3. 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.

  4. Mortality of COVID-19 [ Time Frame: 12 months ]
    Survival rates overall will be determined in assessing the mortality of COVID-19.

  5. 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).

  6. 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.

  7. 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.

  8. 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
As part of a secondary objective, we plan to develop a data and specimen repository that acts as a resource for the investigation and analysis of downstream research questions specific to the clinical course of COVID-19, the development of medical countermeasures and diagnostic tests, and, basic biology questions associated with SARS-CoV-2.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

INPATIENT Confirmed and suspected patients with COVID-19 presenting to a Johns Hopkins Health System hospital

OUTPATIENT Identification of Potential Participants / Recruitment Persons > age 18 who received testing for SARS-CoV-2 after attending a Johns Hopkins Health System Testing site.

Criteria

INPATIENT

Inclusion criteria:

  • Newborns to adults 18 years of age or older AND
  • Hospitalized with a suspected or proven infection with SARS-CoV-2.

Exclusion criteria:

  • Confirmed diagnosis of a pathogen unrelated to the objectives of this study AND no indication or likelihood of co-infection with a relevant pathogen. OR
  • Refusal by participant, parent or appropriate representative. OR
  • Individuals with any condition or major comorbidity that the study investigators believe will compromise the patient's ability to comply with the requirements of the study.

OUTPATIENT

Inclusion criteria:

  • Adults 18 years of age or older AND
  • Suspected or proven infection with SARS-CoV-2 pending test results from any Johns Hopkins Health system testing site including individuals who ultimately test negative (for use as negative controls.)

Exclusion criteria:

  • Refusal by participant, parent or appropriate representative. OR
  • Individuals with any condition or major comorbidity that the study investigators believe will compromise the patient's ability to comply with the requirements of the study.

Information from the National Library of Medicine

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


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21217
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Lauren Sauer, MS Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04496466    
Other Study ID Numbers: IRB00245545
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

The COVID-19 Biospecimen Committee evaluates requests from researchers for accessing serum or plasma from COVID-19 patients. The committee's default position will be for investigators to receive premade specimen collections for pilot studies with requests for custom made collections considered after pilot studies are completed.

https://ictr.johnshopkins.edu/coronavirus/biospecimencommittee/


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection