Clinical trial NCT05986435: Long-term Follow-up Study of COVID-19
Official title: Long-term Large Sample Multicenter Follow-up Study of COVID-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 5700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The inpatients with positive SARS CoV-2 nucleic acid test results will be included.

Brief summary: The goal of this observational study is to learn the long-term prognosis of patients and the clinical characteristics of complications, which is of great significance for treatment of novel coronavirus infection pneumonia.

This trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test results. This trial does not involve the use of specific drug. Participants's health and psychological status will be observed at the preset time points. The blood, feces, urine samples of patients will be collected for relevant tests.

Detailed description: After the patients are enrolled, record the patient's treatment regimens, blood routine results, blood biochemistry results, cytokines results, lung imaging results, and cranial imaging results, understand the patient's current clinical manifestations, evaluate the patient's psychological status and quality of life, and collect samples of the patients' blood, feces, urine, and other related tests.

Collection of clinical samples: collect blood, urine, throat swabs and other samples from patients with confirmed novel coronavirus pneumonia (Nucleic acid test positive), and collect samples for relevant tests at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months after discharge of patients, and record the clinical manifestations of patients.

Eligibility criteria: Inclusion Criteria:

* Patients with confirmed COVID-19

Exclusion Criteria:

* Combined infection with influenza virus, mycoplasma, and chlamydia.

Primary outcomes:
measure: clinical manifestation
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary outcomes:
measure: psychological status
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
measure: quality of life scores
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
measure: cranial imaging results
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
measure: lung imaging results
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
measure: cytokines level
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
measure: blood biochemistry results
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
measure: routine blood test results
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
measure: treatment regimens
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
measure: survival rate
timeFrame: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
state: Hu Bei Province
city: Wuhan
country: China
facility: Wuhan Seventh Hospital
state: Hu Bei Province
Study officials:
affiliation: Tongji Hospital
name: Qin Ning, Professor
role: PRINCIPAL_INVESTIGATOR
References: