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

NCT06349720 | Recruiting

• 1 other identifier: KF-2023-355
• Study Type: observational
• Target: 17,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19 Patients

Outcome Measures

Primary Outcomes (7)

• Immunological characteristics associated with functional impairments in COVID-19 convalescent patients

  6 months, 12 months and 24 months

• Changes in laboratory examination indicators

  6 months, 12 months and 24 months

• High-resolution CT of the chest

  6 months, 12 months and 24 months

• Pulmonary function test

  3 months, 12 months

• Multi-omics changes and characteristics associated with functional impairments in COVID-19 convalescent patients

  6 months, 12 months and 24 months

• Inflammatory factors related to body dysfunction in COVID-19 rehabilitation patients

  6 months, 12 months and 24 months

• Regular rehabilitation assessment following respiratory rehabilitation intervention in COVID-19 patients

  6 months, 12 months and 24 months

Study Arms (3)

severe vs non-severe

COVID-19 patients vs healthy volunteers

emote respiratory rehabilitation vs outpatient respiratory rehabilitation

Behavioral: respiratory rehabilitation

Interventions

respiratory rehabilitation BEHAVIORAL

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.

emote respiratory rehabilitation vs outpatient respiratory rehabilitation

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospital

You may qualify if:

• Meets the diagnostic criteria for confirmed cases according to the "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10)";
• 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;
• Agrees to the researcher's collection of their peripheral blood samples, saliva samples, and urine samples for the needs of the study.

You may not qualify if:

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

Sponsors & Collaborators

• Zhaohui Tong: lead

Study Sites (1)

Beijing Institute of Respiratory Medicine

Beijing, Beijing Municipality, 100027, China

RECRUITING

Central Study Contacts

Zhaohui Tong, Doctor

CONTACT

+86 139 1093 0309; 13910930309@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 5, 2024
• Study Start: June 7, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)