NCT05986435

Brief Summary

The goal of this observational study is to learn the long-term prognosis of patients and the clinical characteristics of complications, which is of great significance for treatment of novel coronavirus infection pneumonia. This trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test results. This trial does not involve the use of specific drug. Participants's health and psychological status will be observed at the preset time points. The blood, feces, urine samples of patients will be collected for relevant tests.

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
5,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

October 20, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 14, 2023

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

August 8, 2023

Last Update Submit

August 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • clinical manifestation

    3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge

Secondary Outcomes (9)

  • psychological status

    3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge

  • quality of life scores

    3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge

  • cranial imaging results

    3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge

  • lung imaging results

    3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge

  • cytokines level

    3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge

  • +4 more secondary outcomes

Eligibility Criteria

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

The inpatients with positive SARS CoV-2 nucleic acid test results will be included.

You may qualify if:

  • Patients with confirmed COVID-19

You may not qualify if:

  • Combined infection with influenza virus, mycoplasma, and chlamydia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

RECRUITING

Wuhan Seventh Hospital

Wuhan, Hubei, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

There are many patients who are prospectively observed. Their samples will be collected. The samples will include blood, urine, throat swabs etc.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Qin Ning, Professor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qin Ning, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, department of infection

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 14, 2023

Study Start

October 20, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 14, 2023

Record last verified: 2023-07

Locations