NCT04365634

Brief Summary

In the single-centered, retrospective study, 306 hospital patients (including 129 diabetes and 177 non-diabetes patients) confirmed with SARS-CoV-2 infection were enrolled in Tongji Hospital, Wuhan, China. Clinical characteristics including clinical manifestation, laboratory parameters, lung CT features and clinical outcomes were compared between diabetes and non-diabetes patients. The prediction factors were analyzed for mortality of COVID-19 by univariate and multivariate analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

February 2, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 25, 2020

Last Update Submit

April 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Find the prediction factors associated with hospitalized death of patients with COVID-19 by univariate and multivariate analysis

    28 days

Secondary Outcomes (3)

  • Demographics and clinical characteristics

    28 days

  • Laboratory parameters and radiography image features

    28 days

  • Treatment, complications and clinical outcomes

    28 days

Study Arms (4)

Diabetes

Diabetes mellitus was diagnosed according to the standards of American Diabetes Association which were briefly described as FPG ≥ 7.0 mmol/L (Fasting is defined as no caloric intake for at least 8 h) or 2-h plasma glucose ≥ 11.1 mmol/L during Oral glucose tolerance test (OGTT), or with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose (RPG) ≥ 11.1 mmol/L. And in this group, we have 129 COVID-19 patients with diabetes.

Non-diabetes

Patients who do not meet the American Diabetes Association's standard diagnosis of diabetes are defined as non-diabetes. And in this group, we have 177 COVID-19 patients without diabetes.

Survivors

COVID-19 patients who survived on the 28th day in hospital belong to survivors group. In the survivors group, we included 201 patients with complete data.

Non-survivors

COVID-19 patients who did not survive on the 28th day in hospital belong to non-survivors group. In the non-survivors group, we included 54 patients with complete data.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China were enrolled. Laboratory confirmed cases were identified with positive viral RNA by real-time RT-PCR detection by the local health authority or our hospital from specimen taken from throat or nasal swab.

You may qualify if:

  • Patients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China.

You may not qualify if:

  • With SARS-CoV-2 RNA detection negative results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

  • Han M, Ma K, Wang X, Yan W, Wang H, You J, Wang Q, Chen H, Guo W, Chen T, Ning Q, Luo X. Immunological Characteristics in Type 2 Diabetes Mellitus Among COVID-19 Patients. Front Endocrinol (Lausanne). 2021 Mar 11;12:596518. doi: 10.3389/fendo.2021.596518. eCollection 2021.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Meifang Han, Professor

    Tongji Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 25, 2020

First Posted

April 28, 2020

Study Start

February 2, 2020

Primary Completion

March 15, 2020

Study Completion

April 1, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations