NCT04292964

Brief Summary

The outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in China has been declared a public health emergency of international concern. Despite lower mortality rate, SARS-CoV-2 has killed more people than SARS and MERS and the number keeps growing. Epidemic studies have been well described clinical features of patients with COVID-19, with the disease severity being an independent predictor of poor outcome. However, there is still no research investigating the prognostic factors of patients with COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

12 days

First QC Date

March 1, 2020

Last Update Submit

March 13, 2020

Conditions

SARS-CoV-2Outcome, Fatal

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    30 days

Secondary Outcomes (2)

  • all-cause mortality

    15 days

  • Severe state

    15 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COVID-19

You may qualify if:

  • Adult aged \>=18years old;
  • Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia.
  • Criteria for severe or critical ill conditions: Respiratory rate \>=30/min; or Rest SPO2\<=93%; or PaO2/FiO2\<=300mmHg.

You may not qualify if:

  • Near-death state (expected survival time less than 24 hours);
  • Malignant tumor;
  • Pregnancy or puerperium women;
  • Patients who refused to participant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Related Publications (2)

  • Wen XS, Jiang D, Gao L, Zhou JZ, Xiao J, Cheng XC, He B, Chen Y, Lei P, Tan XW, Qin S, Zhang DY. Clinical characteristics and predictive value of lower CD4+T cell level in patients with moderate and severe COVID-19: a multicenter retrospective study. BMC Infect Dis. 2021 Jan 12;21(1):57. doi: 10.1186/s12879-020-05741-w.

    PMID: 33435865DERIVED

  • Gao L, Jiang D, Wen XS, Cheng XC, Sun M, He B, You LN, Lei P, Tan XW, Qin S, Cai GQ, Zhang DY. Prognostic value of NT-proBNP in patients with severe COVID-19. Respir Res. 2020 Apr 15;21(1):83. doi: 10.1186/s12931-020-01352-w.

    PMID: 32293449DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 1, 2020

First Posted

March 3, 2020

Study Start

March 1, 2020

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)