NCT06235866

Brief Summary

The investigators retrospectively analyze the clinical characteristics of severe COVID-19 in our hospital, and then establish a prediction model for long-term complications in patients with severe COVID-19, and strengthen follow-up to improve the prognosis of patients.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

October 8, 2023

Last Update Submit

May 7, 2024

Conditions

Keywords

COVID-19 PneumoniaLong-term complicationsLung function

Outcome Measures

Primary Outcomes (2)

  • Lung function

    Pulmonary function indicators improved gradually

    1 year

  • Imaging of the lung

    The residual lesions in the lung were gradually absorbed

    1 year

Study Arms (1)

Follow-up cohort of patients with severe COVID-19

The scores of various scales, pulmonary function and imaging changes of patients with severe COVID-19 were collected at 3 months, 6 months and 12 months after rehabilitation and discharge.

Other: Pulmonary rehabilitation

Interventions

According to the pulmonary rehabilitation guidelines, patients with severe COVID-19 were given regular rehabilitation treatment, including breathing exercises and physical rehabilitation exercises.

Follow-up cohort of patients with severe COVID-19

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with severe COVID-19 in our hospital from December 8, 2022 to January 31, 2023 were enrolled

You may qualify if:

  • The patient met the diagnostic criteria for severe COVID-19

You may not qualify if:

  • Pregnant women Patients who died of COVID-19 Patients younger than 18 years of age without pulmonary CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Follow-up of patients with severe COVID-19

Wuhan, 430000, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2023

First Posted

February 1, 2024

Study Start

February 1, 2023

Primary Completion

September 30, 2024

Study Completion

November 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

The project confidentiality agreement was observed, but the IPD could be made public after the study was completed.

Locations