Clinical trial NCT04456101: Study on the Recovery of Pulmonary Function, Chest CT, Airway Microbiota, Hematologic, and Immune & Inflammatory Conditions in COVID-19 Rehabilitation Patients
Official title: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Covid-19 rehabilitation was the experimental group, and the healthy control group was the conventional control group

Brief summary: The intent of this study was to examine the health status of individuals who had been confirmed with COVID-19 in the year after their recovery. Parameters studied included serum levels of SARS coronavirus 2 (SARS-CoV 2) IgG antibody, SARS-CoV-2 nucleic acid test, hematology indicators (blood routine, liver function, kidney function, myocardial enzymes, coagulation function, etc), lung function test, imaging data and airway microbiota data. In addition, we explored the systematic Immune \& Inflammation in some of the individuals recovering from COVID-19.

Detailed description: About 20% of COVID-19 developed into a critical illness and about 2% died. The global epidemic continues to develop, but some patients in China have entered the rehabilitation period, which is accompanied by a large number of respiratory symptoms and pulmonary fibrosis, bringing serious harm to the country. Therefore, early accurate detection and prediction of the development trend of patients in rehabilitation period and targeted treatment measures for corresponding patients are the key to the success of COVID-19 rehabilitation period. It will play a key role in the stratified management of the post-epidemic situation, which is crucial to improve the quality of life of COVID-19 patients. We aim to explore the clinical characteristics of rehabilitation patients by detecting some indicators of patients in rehabilitation period, including serum IgG and IgM antibody of SARS-CoV 2, SARS-CoV-2 nucleic acid, hematology indicators (blood routine, liver function, kidney function, myocardial enzymes, coagulation function, etc), pulmonary function, chest CT imaging, systematic Immune \& Inflammation states.

Eligibility criteria: Inclusion Criteria:

1. Individuals recovering from COVID-19, or asymptomatic COVID-19 patients with laboratory test for SRARS-COV2 turning negative, or healthy volunteers without COVID-19.
2. The age range is 18-80 years.
3. Subjects or their family members agree to participate in the study and sign informed consent.
4. The previously diagnosed individuals have been cured for about 1 month.

Exclusion Criteria:

1. Woman who is breastfeeding, pregnant, or preparing to become pregnant.
2. Patients with cognitive impairment or poor compliance as determined by the investigator.
3. Participants in other clinical trials.
4. Subjects who were not suitable for clinical trials determined by the investigator.

Primary outcomes:
measure: Pulmonary Function
timeFrame: an average of 1 to 3 months after recovery
measure: Chest CT
timeFrame: an average of 1 to 3 months after recovery
measure: Changes in hematology
timeFrame: an average of 1 to 3 months after recovery
measure: Changes in immune and inflammatory states
timeFrame: an average of 1 to 3 months after recovery
measure: St. George's Respiratory Questionnaire(SGRQ)
timeFrame: an average of 1 to 3 months after recovery
measure: Modified British medical research council (mMRC)
timeFrame: an average of 1 to 3 months after recovery
measure: COPD Assessment test (CAT)
timeFrame: an average of 1 to 3 months after recovery
measure: Airway Microbiota
timeFrame: an average of 1 to 3 months after recovery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Yang Jin, professor
role: PRINCIPAL_INVESTIGATOR
References: