Investigating Long-term Health Effects and Complications in COVID-19 Recoveries

April 4, 2024 updated by: Zhaohui Tong

A Study of the Trajectory of Overall Systemic Health Outcomes and Potential Complications in Recovered COVID-19 Patients.

Clarify the incidence of functional impairments in cured COVID-19 patients and identify influencing factors. Build a multi-omics database for COVID-19 patients in the recovery period to elucidate the biological biomarkers and targets associated with functional impairments. Comprehensive exploration of the long-term prognosis, complications, sequelae, and risk factors of COVID-19 patients after Omicron infection, as well as their immune characteristics. Compare the impact of different strains of the COVID-19 virus on prognosis and immune response. Develop comprehensive rehabilitation intervention strategies for COVID-19 patients with functional impairments and evaluate the impact of different intervention methods on their prognosis. Based on clinical data, multi-omics data, and precise rehabilitation assessment data, construct predictive models for prognosis and rehabilitation effectiveness in COVID-19, providing scientific evidence for the implementation of effective COVID-19 rehabilitation measures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

17000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100027
        • Recruiting
        • Beijing Institute of Respiratory Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Hospital

Description

Inclusion Criteria:

  1. Meets the diagnostic criteria for confirmed cases according to the "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10)";
  2. The participant or the authorized representative understands the entire purpose of the study, voluntarily participates in the research, and signs an informed consent form, ensuring that they can complete regular assessments at the relevant participating units and receive necessary rehabilitation treatment as required;
  3. Agrees to the researcher's collection of their peripheral blood samples, saliva samples, and urine samples for the needs of the study.

Exclusion Criteria:

  1. Women who are pregnant or breastfeeding;
  2. Individuals with mental disorders that affect normal communication;
  3. Those who refuse to participate in regular assessments and rehabilitation treatments;
  4. Individuals who decline to provide specimens required for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
severe vs non-severe
COVID-19 patients vs healthy volunteers
emote respiratory rehabilitation vs outpatient respiratory rehabilitation
Behavioral: respiratory rehabilitation

Emote respiratory rehabilitation:Patients wear monitoring devices and upload real-time monitoring data such as vital signs through the FREE rehabilitation app installed on their personal phones. Medical staff monitor changes in patients' vital signs in real time through the FREE rehabilitation app on the medical end, and adjust respiratory rehabilitation plans based on their phone or video guidance.

Outpatient respiratory rehabilitation:Traditional outpatient respiratory rehabilitation is based on a group approach, with individualized intensity determined based on baseline assessment results, and is conducted under supervision twice a week for a period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunological characteristics associated with functional impairments in COVID-19 convalescent patients
Time Frame: 6 months, 12 months and 24 months
6 months, 12 months and 24 months
Changes in laboratory examination indicators
Time Frame: 6 months, 12 months and 24 months
6 months, 12 months and 24 months
High-resolution CT of the chest
Time Frame: 6 months, 12 months and 24 months
6 months, 12 months and 24 months
Pulmonary function test
Time Frame: 3 months, 12 months
3 months, 12 months
Multi-omics changes and characteristics associated with functional impairments in COVID-19 convalescent patients
Time Frame: 6 months, 12 months and 24 months
6 months, 12 months and 24 months
Inflammatory factors related to body dysfunction in COVID-19 rehabilitation patients
Time Frame: 6 months, 12 months and 24 months
6 months, 12 months and 24 months
Regular rehabilitation assessment following respiratory rehabilitation intervention in COVID-19 patients
Time Frame: 6 months, 12 months and 24 months
6 months, 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhaohui Tong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Estimated)

June 7, 2024

Study Completion (Estimated)

June 7, 2024

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF-2023-355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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