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

NCT ID: NCT06349720

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

17000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-07

Study Completion Date

2024-06-07

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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severe vs non-severe

No interventions assigned to this group

COVID-19 patients vs healthy volunteers

No interventions assigned to this group

emote respiratory rehabilitation vs outpatient respiratory rehabilitation

respiratory rehabilitation

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhaohui Tong

OTHER

Sponsor Role lead

Responsible Party

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Zhaohui Tong

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Beijing Institute of Respiratory Medicine

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaohui Tong, Doctor

Role: CONTACT

+86 139 1093 0309

Facility Contacts

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Zhaohui Tong, Dr

Role: primary

+86 010 8523 1000

Other Identifiers

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KF-2023-355

Identifier Type: -

Identifier Source: org_study_id

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