Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04628637 |
| Other study ID # |
Clinical-2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 16, 2020 |
| Est. completion date |
October 10, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Kafkas University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Covid-19 infection was declared a global pandemic by WHO on March 11, 2020. GRP78 protein is
known to be involved in the intrusion of numerous viruses. Our current study tries to provide
some insight into the variation of GRP78 protein levels in patients with Covid-19(-)
pneumonia, Covid-19(+) pneumonia, and CT negative Covid-19 infection in comparison to the
normal population through a larger number of cases.
42 patients who have Covid-19(-) pneumonia; 72 patients who have Covid-19 infection (30
pneumonia,42 CT negative patients) and 30 patient who have no known diseases (control group)
will be included in the study after the clinical and radiological evaluation. Serum GRP78
levels of the subjects will be measured through a commercially available enzyme-linked
immunosorbent assay (ELISA) kit.
Description:
Caused by a new type of coronavirus (SARS-CoV-2) that emerged in China in late 2019 and then
were imported throughout the world, Covid-19 infection was declared a global pandemic by WHO
on March 11, 2020 (1). Covid-19 infection may manifest itself in severe clinical conditions,
ranging from viral upper respiratory tract infection to pneumonia, sepsis, septic shock, and
even acute respiratory distress syndrome (ARDS), in symptomatic patients .
This study tries to provide some insight into the variation of GRP78 protein levels in
patients with Covid-19 (-) pneumonia, Covid-19 (+) pneumonia, and CT negative Covid-19
infection in comparison to the normal population through a larger number of cases.
The present study is a prospective case-control study, and the required approval was obtained
from the Ethics Committee of Pamukkale University prior to the study (60116787-020 / 26598
numbered).
The present study will be included the patients who were admitted between April 2020 and June
2020 to Covid-19 pandemic outpatient clinic of the emergency department (ED) with symptoms of
upper respiratory tract infection and pneumonia, were asymptomatic, were established to be
Covid-19 PCR (+) during contact tracing, and presented to the ED for further examination and
treatment. After the required information concerning the study will be provided both to the
patient group and to the healthy control group, the written consent forms will be obtained
from all the subjects who agreed to participate in the study. The healthy volunteers with no
known chronic or acute disease or drug use as well as no recent history of infection will be
included study as the control group. Once these subjects will be assessed in accordance with
the inclusion and exclusion criteria, they will be divided into three groups as the
Covid-19(-) pneumonia group, the Covid-19 infection group, and the healthy control group.
Chest CT will performed at the time of admission of the patients to the ED was assessed under
the criteria of the Radiological Society of North America Expert Consensus by an emergency
physician who followed up the patient clinically. The pneumonia cases will be classified in
line with these criteria and recorded in the clinical classification dataset.
Complete blood count, C-reactive protein (CRP), creatinine, urea, d-dimer, and ferritin
parameters, which are routinely checked during admission to the ED, will be recorded in the
dataset. For GRP78 level measurement, after 3 cc blood sample will be taken into a dry tube
and centrifuged at 4000 rpm for 10 minutes, its serum section was separated, and the GRP78
level will be analyzed by the Enzyme-Linked Immunosorbent Assay (ELISA) method. In the
control group, on the other hand, after 3 cc of blood was drawn into a dry tube, and another
3 cc of blood will be placed into an EDTA tube, the GRP78 level was analyzed through the same
methods in the same laboratory.
Serum GRP78 levels of the subjects will be measured through a commercially available
enzyme-linked immunosorbent assay (ELISA) kit (Human Glucose Regulated Protein 78 (GRP78)
ELISA Kit, Sun Long, SL2048Hu, China), as per the manufacturer's protocol.
As a result of the power analysis made in line with the presumptions since a
similarly-organized reference study did not exist, at least 84 people (min. 28 for each
cohort) were needed to achieve 90% power at 95% confidence interval, assuming that the
projected effect size would be medium-high (f = 0.4).
42 patients were eventually will be included in the Covid-19 (-) pneumonia group.
A total of 72 patients (30 Covid-19 pneumonia; 42 CT-negative Covid-19 infection) will be
included in the Covid-19 infection group.
