NCT04403009

Brief Summary

To investigate the difference of the difference between the nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the fatal Patients .The cross sectional study was undertaken to compare the clinical information (laboratory and radiologic characteristics)of nonfatal participants and fatal cases. The investigators wish figure out the clinical character of the fatal participants. The result may help the physician to find the fatal patients with COVID-19 more easily. The fatal patients with COVID-19 could be treated early.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

April 21, 2020

Last Update Submit

March 4, 2023

Conditions

Outcome Measures

Primary Outcomes (12)

  • Lymphocyte cell

    the counting of Lymphocyte(counts/L)

    2 month

  • d-dimer

    d-dimer(mg/L)

    2 month

  • PLT

    the counting of Platelets((counts/L))

    2 month

  • CRP

    the level of C-reactive protein (mg/uL)

    2 month

  • LDH

    lactate dehydrogenase ( U/L)

    2 month

  • CK

    creatine kinase (U/L)

    2 month

  • PT

    prothrombin time(second)

    2 month

  • ALT

    alanine aminotransferase(U/L)

    2 month

  • AST

    aspartate aminotransferase(U/L)

    2 month

  • NK cell

    natural killer cell(counts/L)

    2 month

  • PCT

    procalcitonin(ng/ml)

    2 month

  • IL-6

    interleukin-6(mg/L)

    2 month

Secondary Outcomes (1)

  • the clinical difference of radiologic characteristics between the fatal patients with COVID -19 and the non fatal cases

    2 months

Other Outcomes (1)

  • SPO2

    2 month

Study Arms (2)

the nonsevere Coronavirus Disease 2019 Patients

Other: no intervention

the severe Coronavirus Disease 2019 Patients

Other: no intervention

Interventions

no intervention

the nonsevere Coronavirus Disease 2019 Patientsthe severe Coronavirus Disease 2019 Patients

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients with Coronavirus Disease 2019

You may qualify if:

  • The patients with Coronavirus Disease 2019
  • Positive result on real-time reverse-transcriptase-polymerase-chain-reaction
  • Positive result on chest computed tomography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, 520120, China

Location

Hankou Hospital

Wuhan, Hubei, 430014, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • jianheng zhang, MD

    First Afiliated hospital of Guangzhou medical university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2020

First Posted

May 27, 2020

Study Start

February 1, 2020

Primary Completion

June 6, 2020

Study Completion

June 20, 2020

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations