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

NCT04456101 | Unknown

• 1 other identifier: NCIP03
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yang Jin, professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juanjuan Xu, professor

CONTACT

15972930101; whuhjy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Respiratory and Critical Care Medicine

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 2, 2020
• Study Start: June 19, 2020
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)