NCT04279782

Brief Summary

Outbreak of 2019 Novel Coronavirus infection started in Wuhan and quickly spread to the world. Suspected patients were isolated and treated in our department. Clinical data was recorded to investigate the clinical features of patients confirmed and excluded diagnosed of 2019 Novel Coronavirus infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

January 20, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 15, 2020

Last Update Submit

February 20, 2020

Conditions

Keywords

2019 Novel Coronavirus

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    If the patient will survive after comprehensive treatment

    28 days

Secondary Outcomes (3)

  • Chest computed tomography

    28 days

  • Recovery Time

    28 days

  • Depression evaluation

    28 days

Study Arms (2)

Exclusion group

Patients with two consecutive negative results of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swabs

Other: Comprehensive treatment

Confirmed group

Patients with positive result of detection for 2019 Novel Coronavirus nucleic acid from pharyngeal swab

Other: Comprehensive treatment

Interventions

Comprehensive treatment includes antiviral therapy, antibiotics therapy, symptomatic treatment, supportive therapy.

Confirmed groupExclusion group

Eligibility Criteria

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

Suspected patients of 2019 Novel Coronavirus infection

You may qualify if:

  • Epidemiological history including resident of Hubei province, or travel history to Hubei province or exposure to suspected patients in the past two weeks.
  • Symptoms like fever, fatigue, myalgia, headache, cough, sputum production, chest tightness, dyspnea, etc.
  • White blood cells decreased or were normal, or lymphocytes decreased, and chest CT images showed typical findings of viral pneumonia.

You may not qualify if:

  • Patients can not follow-up;
  • Investigator considering inappropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (1)

  • Peng L, Liu J, Xu W, Luo Q, Chen D, Lei Z, Huang Z, Li X, Deng K, Lin B, Gao Z. SARS-CoV-2 can be detected in urine, blood, anal swabs, and oropharyngeal swabs specimens. J Med Virol. 2020 Sep;92(9):1676-1680. doi: 10.1002/jmv.25936. Epub 2020 Apr 30.

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Liang Peng, Doctor

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxiong Xu, Doctor

CONTACT

Liang Peng, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professer

Study Record Dates

First Submitted

February 15, 2020

First Posted

February 21, 2020

Study Start

January 20, 2020

Primary Completion

January 31, 2021

Study Completion

February 28, 2021

Last Updated

February 24, 2020

Record last verified: 2020-02

Locations