Study on the Recovery of Pulmonary Function, Chest CT, Airway Microbiota, Hematologic, and Immune & Inflammatory Conditions in COVID-19 Rehabilitation Patients

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Juanjuan Xu, professor; Phone Number: 15972930101; Email: whuhjy@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Covid-19 rehabilitation was the experimental group, and the healthy control group was the conventional control group

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Control group; healthy individuals without COVID-19
Severe/Critical COVID-19 rehabilitation group; ①Individuals recovering from Severe/Critical COVID-19
mild/moderate COVID-19 rehabilitation group; Individuals recovering from mild/moderate COVID-19
asymptomatic COVID-19 rehabilitation group; Asymptomatic COVID-19 individuals with laboratory test for SRARS-COV2 turning negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Function	Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) for lung volume, peak expiratory flow (PEF) for velocity, carbon monoxide diffusion capacity (DLCO) for pulmonary diffusion function.	an average of 1 to 3 months after recovery
Chest CT	Percentage of lungs that contain reticular patterns, Percentage of lungs that contain pure ground-glass opacification, Percentage of lungs that contain honeycombing, Percentage of lungs that contain traction bronchiectasis, Percentage of lungs that contain strip-like consolidation.	an average of 1 to 3 months after recovery
Changes in hematology	blood routine indexes included leucocytes(×109/L), neutrophils(×109/L), lymphocytes(×109/L), monocytes(×109/L), eosinophils(×109/L), platelets(×109/L). Biochemical and coagulation function indicators included total protein(umol/L), creatinine (umol/L), uric acid (umol/L), lactic dehydrogenase(U/L), C-reactive protein (mg/L), aspartate aminotransferase (U/L), glutamic-pyruvic transaminase (U/L), D-dimer,(ug/L), fibrinogen(g/L), Active part thrombin time (APTT), prothrombin time (PT), thrombin time (TT) and troponin (TNI).	an average of 1 to 3 months after recovery
Changes in immune and inflammatory states	Immune cells and related cell factors included CD8+T cell(×109/L), CD4+T cell(×109/L), bone marrow derived suppressor cells(×109/L), regulatory T cells(×109/L), natural killer cell(×109/L), dendritic cell(×109/L), macrophages(×109/L), interleukin-4(IL-4)ug/L, IL-2 ug/L, IL-17 ug/L, IL-15 ug/L, IL-16 ug/L, IL-1 ug/L, IL-6 ug/L, IL-10 ug/L, tumor necrosis factor ug/L, interferon gamma ug/L, eotaxin-3 ug/L, eotaxin ug/L.	an average of 1 to 3 months after recovery
St. George's Respiratory Questionnaire(SGRQ)	St. George's Respiratory Questionnaire total score(0-3989.4), St. George's Respiratory Questionnaire symptoms score(0-662.5); St. George's Respiratory Questionnaire impacts score(0-2117.8); St. George's Respiratory Questionnaire activity score(0-1209.1). The higher the score, the worse the lung.	an average of 1 to 3 months after recovery
Modified British medical research council (mMRC)	mMRC only reflects symptom of dyspnea. A score of 0-1 is considered as fewer symptom, and ≥2 is considered as more symptom.	an average of 1 to 3 months after recovery
COPD Assessment test (CAT)	CAT score was a comprehensive symptom score ranging from 0 to 40 points. The higher the score, the worse the lung.	an average of 1 to 3 months after recovery
Airway Microbiota	Airway Microbiota of exhaled breath condensate in individuals were detected.	an average of 1 to 3 months after recovery

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Yang Jin, professor, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Anticipated): December 12, 2023
• Study Completion (Anticipated): December 12, 2023

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: NCIP03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No