Clinical trial NCT06349720: Investigating Long-term Health Effects and Complications in COVID-19 Recoveries
Official title: A Study of the Trajectory of Overall Systemic Health Outcomes and Potential Complications in Recovered COVID-19 Patients.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Patients
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 17000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Immunological characteristics associated with functional impairments in COVID-19 convalescent patients
timeFrame: 6 months, 12 months and 24 months
measure: Changes in laboratory examination indicators
timeFrame: 6 months, 12 months and 24 months
measure: High-resolution CT of the chest
timeFrame: 6 months, 12 months and 24 months
measure: Pulmonary function test
timeFrame: 3 months, 12 months
measure: Multi-omics changes and characteristics associated with functional impairments in COVID-19 convalescent patients
timeFrame: 6 months, 12 months and 24 months
measure: Inflammatory factors related to body dysfunction in COVID-19 rehabilitation patients
timeFrame: 6 months, 12 months and 24 months
measure: Regular rehabilitation assessment following respiratory rehabilitation intervention in COVID-19 patients
timeFrame: 6 months, 12 months and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Respiratory Medicine
state: Beijing
Study officials:
References: