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NCT04496466 · ClinicalTrials.gov registry record
Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 702
- Enrollment target
NCT04496466: Completed study, sponsored by Johns Hopkins University.
NCT04496466 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 702 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04496466 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 702 participants
- Enrollment target
Study 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., ac
Primary Outcome
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).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 702 participants |
| Start Date | 2020-04-09 |
| Est. Completion | 2021-10-31 |
What the finished NCT04496466 record still lists
NCT04496466 is an observational study that tracks outcomes without assigning an intervention. The registered 702 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04496466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04496466 about?
NCT04496466 is a clinical study titled "Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)". 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 p...
What is the current status of trial NCT04496466?
This trial is currently completed. The enrollment target is 702 participants. The study started on 2020-04-09. Estimated completion is 2021-10-31.
Who is sponsoring clinical trial NCT04496466?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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