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

Recruiting

• Conditions: COVID-19 Patients
• Interventions: Behavioral: respiratory rehabilitation

• Registration Number: NCT06349720
• Lead Sponsor: Zhaohui Tong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-07
• Status Verified: 2024-04
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05
• Primary Completion: 2024-06-07
• Study Completion: 2024-06-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
emote respiratory rehabilitation vs outpatient respiratory rehabilitation	respiratory rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Changes in laboratory examination indicators	6 months, 12 months and 24 months
Pulmonary function test	3 months, 12 months
Inflammatory factors related to body dysfunction in COVID-19 rehabilitation patients	6 months, 12 months and 24 months
Immunological characteristics associated with functional impairments in COVID-19 convalescent 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
Multi-omics changes and characteristics associated with functional impairments in COVID-19 convalescent patients	6 months, 12 months and 24 months
High-resolution CT of the chest	6 months, 12 months and 24 months

Trial Locations

Locations (1)

Beijing Institute of Respiratory Medicine; 🇨🇳 Beijing, Beijing, China