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High GRP78 Levels in Covid-19 Infection: A Case-Control Study

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ClinicalTrials.gov Identifier: NCT04628637
Recruitment Status : Completed
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Pamukkale University Faculty of Medicine
Acibadem Mehmet Ali Aydinlar University Faculty of Medicine
Information provided by (Responsible Party):
Ramazan Sbirli, Kafkas University

Brief 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.


Condition or disease Intervention/treatment
Covid19 Endoplasmic Reticulum Stress Other: Serum protein level analysis

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Study Type : Observational
Actual Enrollment : 144 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: High GRP78 Levels in Covid-19 Infection: A Case-Control Study
Actual Study Start Date : April 16, 2020
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Control Group

Inclusion Criterias are consisted of; Not to have known acute, subacute or chronic disease history, Not to suffer from any infection in the last fortnight, Not to be on a particular medication, Presenting to the ED with reasons other than infectious complaints, and Giving their written consent to participate in the study.

The exclusion criteria consisted of; Diagnosis of kidney and liver failure, Acute pulmonary embolism Chronic inflammatory disease history (rheumatological disease, autoimmune disease) Pregnancy Presence of any cancer diagnosis Chronic obstructive pulmonary disease Asthma disease History of cerebrovascular disease

Other: Serum protein level analysis
Serum GRP78 levels of the subjects were 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. The detection rate of this kit is 16 pg/mL.

Covid-19 (-) Pneumonia Group
Inclusion Criterias are consisted of; Presenting to the Covid-19 outpatient policlinic of the ED with pneumonia symptoms To have CT imagings were not compatible with Covid-19 pneumonia in accordance with the Radiological Society of North America Expert Consensus (RSNAEC) criteria To have nasopharyngeal swab samples taken in the ED were negative for PCR, and To give their informed consent to participate in the study. Exclusion Criteria The exclusion criteria consisted of diagnosis of kidney and liver failure, Acute pulmonary embolism Chronic inflammatory disease history (rheumatological disease, autoimmune disease) Pregnancy Presence of any cancer diagnosis Chronic obstructive pulmonary disease Asthma disease History of cerebrovascular disease To have a CT imagings that is compatible with Covid-19 pneumonia but whose PCR tests were negative
Other: Serum protein level analysis
Serum GRP78 levels of the subjects were 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. The detection rate of this kit is 16 pg/mL.

Covid-19 Infection Group

This cohort included the patients InculUsion Criteria Presenting Whose CT imagings were normal in accordance with the RSNAEC criteria and whose PCR tests were positive To have Covid-19 PCR tests were positive as a result of contact tracing, Presenting to the ED for further examination.

The exclusion criteria consisted of; Diagnosis of kidney and liver failure, Acute pulmonary embolism Chronic inflammatory disease history (rheumatological disease, autoimmune disease) Pregnancy Presence of any cancer diagnosis Chronic obstructive pulmonary disease Asthma disease History of cerebrovascular disease To have a CT imagings that is compatible with Covid-19 pneumonia but whose PCR tests were negative.

Other: Serum protein level analysis
Serum GRP78 levels of the subjects were 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. The detection rate of this kit is 16 pg/mL.




Primary Outcome Measures :
  1. Determination of the change of the serum GRP-78 protein levels in patients who have Covid-19 infection compared to control group [ Time Frame: 2 months ]
    The change of the serum levels of the GRP-78 protein levels in patient who have Covid 19 infection compared to control group. It will be determined whether GRP-78 protein level change in Covid-19 infection.

  2. Determination of the change of the serum GRP-78 protein levels in patients who have Covid-19 infection compared to Covid-19 negative pneumonia group. [ Time Frame: 2 months ]
    The change of the serum levels of the GRP-78 protein levels in patient who have Covid 19 infection compared to Covid-19 negative pneumonia group.. It will be determined whether GRP-78 protein level change in Covid-19 (-) pneumonia.


Secondary Outcome Measures :
  1. Determination of the correlations between laboratory parameters, clinical parameters and radiological parameters [ Time Frame: 2 months ]
    Correlationships will be analysed between Complete blood count, C-reactive protein (CRP), creatinine, urea, d-dimer, and ferritin parameters, CURB-65 score, PORT score, symptom duration, CT severity score.


Biospecimen Retention:   Samples Without DNA
Blood serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The present study 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 was provided both to the patient group and to the healthy control group, the written consent forms were 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 were included study as the control group. Once these subjects were assessed in accordance with the inclusion and exclusion criteria, they were divided into three groups as the Covid-19(-) pneumonia group, the Covid-19 infection group, and the healthy control group.
Criteria

Healthy group (Control group) Inclusion Criteria

  • To have no known acute, subacute or chronic disease history,
  • Not to not suffer from any infection in the last fortnight,
  • Not to be on a particular medication
  • Presenting to the ED with reasons other than infectious complaints .Giving their written consent to participate in the study.

Exclusion Criteria:

  • Diagnosis of kidney and liver failure,
  • Acute pulmonary embolism,
  • Chronic inflammatory disease history (rheumatological disease, autoimmune disease),
  • Pregnancy,
  • Presence of any cancer diagnosis,
  • Chronic obstructive pulmonary disease,
  • Asthma disease
  • History of cerebrovascular disease

Patient Groups;

Covid-19 infection Group;

Inculusion Criteria .Presenting Whose CT imagings were normal in accordance with the RSNAEC criteria.

  • To have positive Covid-19 PCR test
  • To have Covid-19 PCR tests were positive as a result of contact tracing,
  • Presenting to the ED for further examination.

Exclusion Criteria

  • Diagnosis of kidney and liver failure,
  • Acute pulmonary embolism
  • Chronic inflammatory disease history (rheumatological disease, autoimmune disease)
  • Pregnancy
  • Presence of any cancer diagnosis
  • Chronic obstructive pulmonary disease
  • Asthma disease
  • History of cerebrovascular disease .To have a CT imagings that is compatible with Covid-19 pneumonia but whose PCR tests were negative.

Covid-19 Pneumonia Group

Inclusion Criteria

  • Presenting to the Covid-19 outpatient policlinic of the ED with pneumonia symptoms
  • To have CT imagings were not compatible with Covid-19 pneumonia in accordance with the .Radiological Society of North America Expert Consensus (RSNAEC) criteria
  • To have nasopharyngeal swab samples taken in the ED were negative for PCR, and .To give their informed consent to participate in the study.

Exclusion Criteria

  • To have diagnosis of kidney and liver failure,
  • Acute pulmonary embolism
  • Chronic inflammatory disease history (rheumatological disease, autoimmune disease)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628637


Locations
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Turkey
Aylin Koseler
Denizli, Outside Of The US, Turkey, 20070
Sponsors and Collaborators
Kafkas University
Pamukkale University Faculty of Medicine
Acibadem Mehmet Ali Aydinlar University Faculty of Medicine
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Responsible Party: Ramazan Sbirli, Dr., Kafkas University
ClinicalTrials.gov Identifier: NCT04628637    
Other Study ID Numbers: Clinical-2
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection