Long-term Follow-up Study of COVID-19

COVID-19 Clinical Trial

Official title:

Long-term Large Sample Multicenter Follow-up Study of COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986435
• Other study ID #: PROCOVER
• Status: Recruiting
• Start date: October 20, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Tongji Hospital
• Contact: Qin Ning, Professor
• Phone: +8613971521450
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5700
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with confirmed COVID-19

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hu Bei Province
China	Wuhan Seventh Hospital	Wuhan	Hu Bei Province

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical manifestation		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary	psychological status		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary	quality of life scores		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary	cranial imaging results		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary	lung imaging results		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary	cytokines level		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary	blood biochemistry results		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary	routine blood test results		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary	treatment regimens		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge
Secondary	survival rate		3 months, 6 months, 12 months, 18 months, 24 months, 36 months after patients discharge