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

NCT04628637 | Completed

• 1 other identifier: Clinical-2
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Endoplasmic Reticulum Stress

Outcome Measures

Primary Outcomes (2)

• Determination of the change of the serum GRP-78 protein levels in patients who have Covid-19 infection compared to control group

  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 months

• 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.

  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.

  2 months

Secondary Outcomes (1)

• Determination of the correlations between laboratory parameters, clinical parameters and radiological parameters

  2 months

Study Arms (3)

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

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

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

Interventions

Serum protein level analysis OTHER

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.

Control Group; Covid-19 (-) Pneumonia Group; Covid-19 Infection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Diagnosis of kidney and liver failure,

Sponsors & Collaborators

• Kafkas University: lead
• Pamukkale University Faculty of Medicine: collaborator
• Acibadem Mehmet Ali Aydinlar University Faculty of Medicine: collaborator

Study Sites (1)

Aylin Koseler

Denizli, Outside of the US, 20070, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 13, 2020
• Study Start: April 16, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 10, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

TU (1)