Study for Quantitative Analysis of the Recovered COVID-19 Patients by 18F-FDG-PET/CT

NCT04519255 | Unknown

• 1 other identifier: ZDWY.FZYX.008
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, clinically cured patients with severe COVID-19 were used to evaluate the therapeutic effect of COVID-19 and the recovery and health status of patients over time with highly sensitive PET/CT imaging technology. At the same time, PET/CT whole body scan, dynamic imaging and mathematical dynamic model were combined to evaluate the functions of the heart, lung, liver, kidney, brain and other important organs and the outcome of inflammatory lesions in clinically cured COVID-19 patients.

Conditions

PET/CT; COVID-19; Respiratory Function; Inflammatory Lesions

Outcome Measures

Primary Outcomes (5)

• Number of clinically cured patients with severe COVID-19

  Count the number of clinically cured patients with severe COVID-19

  6 months

• Number of clinically cured patients with mild COVID-19

  Count the number of clinically cured patients with mild COVID-19

  6 months

• Number of healthy people who are not infected with COVID-19

  Count the number of healthy people who are not infected with COVID-19

  6 months

• Ki comparison between the severe, the mild and the healthy

  Ki of the severe, the mild and the healthy were calculated and compared

  12 months

• SUVmax comparison between the severe, the mild and the healthy

  SUVmax of the severe, the mild and the healthy were calculated and compared

  12 months

Study Arms (3)

Screening of clinically cured patients with severe COVID-19

①Patients with severe COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria; ②Age \> 18 years, age \< 85 years, no gender restriction; ③ All had received COVID-19 drug therapy; ④ ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min; ⑤ Can obtain complete follow-up information, understand the situation of this study and sign informed consent.

Screening of clinically cured patients with mild COVID-19

①Patients with mild COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria; ②Age \> 18 years, age \< 85 years, no gender restriction; ③ All had received COVID-19 drug therapy; ④ ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min; ⑤ Can obtain complete follow-up information, understand the situation of this study and sign informed consent.

Healthy people who are not infected with COVID-19

① Volunteers who are not infected with COVID-19; ②Age \> 18 years, age \< 85 years, no gender restriction; ③ ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min; ④ Can obtain complete follow-up information, understand the situation of this study and sign informed consent.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COVID-19 cured were determined based on nucleic acid tests, CT examinations, and clinical criteria. The age of patient were between 18 and 85 years, meanwhile in Zhuhai they were confirmed as COVID-19, cured and all received by COVID-19 drug therapy.

You may qualify if:

• Screening of clinically cured patients with severe COVID-19:
• Patients with severe COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria;
• Age \> 18 years, age \< 85 years, no gender restriction;
• All had received COVID-19 drug therapy;
• ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min;
• Can obtain complete follow-up information, understand the situation of this study and sign informed consent.
• Screening of clinically cured patients with mild COVID-19:
• Patients with mild COVID-19 cure were determined based on nucleic acid tests, CT examinations, and clinical criteria;
• Age \> 18 years, age \< 85 years, no gender restriction;
• All had received COVID-19 drug therapy;
• ECOG of general condition score: 0-2; No dysfunction of main viscera; Oxygen partial pressure ≥10.64kPa; White blood cells ≥4×109/L; Blood routine hemoglobin ≥9.5g/dL; The absolute count of neutrophils ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; Creatinine ≤1.25 times the upper limit of normal value; The creatinine clearance rate was ≥60ml/min;
• Can obtain complete follow-up information, understand the situation of this study and sign informed consent.

You may not qualify if:

• Poorly controlled diabetics (fasting glucose level and GT;200 mg/dL);
• Any other malignancy within 5 years;
• Breastfeeding and/or pregnant women;
• Those who are prone to severe bleeding;
• Recent severe hemoptysis, severe cough, dyspnea or patients cannot cooperate;
• Severe emphysema, pulmonary congestion and pulmonary heart disease;
• The researchers believe that the subjects may not be able to complete the study or comply with the requirements of the study.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Hongjun Jin

Zhuhai, Guangzhou, 519000, China

Location

Related Publications (1)

• Yao J, Liu J, Bi L, Huang Y, Wang L, Zhang F, Wang Y, Jin H. The imaging quantification of multiple organs by dynamic 18F-FDG PET/CT in discharged COVID-19 patients: A prospective pilot study. Int J Med Sci. 2022 Sep 6;19(10):1539-1547. doi: 10.7150/ijms.73801. eCollection 2022.

  PMID: 36185330 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration

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; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hong Shan, Ph.D

  Fifth Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 19, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: July 31, 2023
• Last Updated: February 5, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)