Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04519255 |
Other study ID # |
ZDWY.FZYX.008 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2020 |
Est. completion date |
July 31, 2023 |
Study information
Verified date |
July 2020 |
Source |
Fifth Affiliated Hospital, Sun Yat-Sen University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Covid-19 (Corona Virus Disease 2019, COVID-19), referred to as "COVID-19", refers to the
pneumonia caused by novel Coronavirus 2019 (2019-NCOV/SARS-COV-2) infection. The clinical
manifestations of the new patients were fever, fatigue and dry cough, while the symptoms of
upper respiratory tract such as nasal congestion and runny nose were rare. Hypoxia occurs.
About half of the patients developed dyspnea after one week, and in severe cases, the rapid
progression was acute respiratory distress syndrome, septic shock, metabolic acidosis that
was difficult to correct, and coagulation dysfunction. After the outbreak of COVID-19 in
China, the National Health Commission issued the Diagnosis and Treatment Plan for COVID-19.
By analyzing the epidemic situation and research progress, it organized experts to timely
revise the diagnosis and treatment plan based on the analysis, study and summary of the
previous medical treatment work.The discharge criteria for COVID-19 patients notified by the
National Health Commission are remission of clinical symptoms, normal body temperature,
normal CT, and negative nucleic acid tests for both tests. So far, the COVID-19 epidemic in
China has been well under control. According to the latest statistics, 84,311 cases have been
confirmed in total, and 1,433 cases have been confirmed so far.But studies (the latest from
Dena Goffman's team, published in the NEJM) suggest that as many as 88 percent of coVID-19
patients are asymptomatic. Do cured patients leave the hospital with a percentage of
asymptomatic patients?In addition, covid-19 cured patients in some regions turned positive
again after discharge, indicating that long-term follow-up monitoring is of great
significance for cured and discharged patients in addition to routine isolation
observation!Moreover the literature at home and abroad other viral infections (such as
hepatitis b, HIV, etc.) to cure patients found that the virus may lurk for a long time, the
virus quantity contained in a very low level, the conventional detection method is difficult
to detect, at the appropriate incentives can lead to attack, so for the new crown cure
patients need close monitoring of systemic inflammation related lesions, and the situation of
the latent virus.However, we still face many problems and challenges. For example, according
to the latest data published by Dena Goffman's team in NEJM, the proportion of asymptomatic
patients is as high as 88%, so the screening of asymptomatic patients is crucial.In many
places, COVID-19 patients cured turn positive again after discharge. Therefore, it is of
great significance to explore the mechanism of COVID-19 turning negative after discharge and
evaluate the effect of novel Coronavirus and COVID-19 on patients' later recovery. Explore
and develop more efficient and sensitive clinical detection methods to evaluate the treatment
effect of covid-19 patients.
Positron emission computed tomography imaging technique is a nuclear medicine clinical
diagnosis of advanced imaging techniques, can be shown on the in vivo biological molecules
(such as 18 F- FDG, tracer nuclide labeled glucose molecules) metabolism, receptors and
neurotransmitter activity of new functional imaging techniques, has been widely used in many
kinds of disease diagnosis and differential diagnosis, a judgment, curative effect
evaluation, viscera function research and development of new drugs, etc. Compared with
traditional anatomical structure imaging, functional imaging PET has the following
advantages: (1) High sensitivity. According to the test, PET molecular probe can pick up
molecular events at the level of PM-NM in vivo. (2) High specificity, for the PET selected
molecular probe, can only imaging the target molecules, for the same family of receptors,
because the binding degree difference can be specifically distinguished; (3) Whole-body
imaging, that is, one time PET imaging can obtain images of all regions of the whole body,
and through the analysis can obtain the dynamic information of the metabolic changes of human
tissues over time, which is of great significance for the research, prevention and evaluation
of diseases.In particular, PET/CT scan provides a more reliable means of systemic monitoring
for viruses that are lurking in all hidden parts of the body. (4) Security is good, although
there are some radioactive nuclide PET need, but the amount of nuclide rarely used with short
half-life, through two aspects of physical decay and biological metabolism function, in a
very short time, client retention, a PET general inspection of radiation dose is far less
than the conventional CT examination of a part, and safe and reliable.