Covid19NCT04628637
High GRP78 Levels in Covid-19 Infection: A Case-Control Study
An observational study of Covid19 and Endoplasmic Reticulum Stress, run by Kafkas University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Endoplasmic Reticulum Stress
- What is being tested?
- Serum protein level analysis
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2020to 10 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 26Show fewer
- 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,
- 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
- To have diagnosis of kidney and liver failure,
- Acute pulmonary embolism
- Chronic inflammatory disease history (rheumatological disease, autoimmune disease)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aylin Koseler
Denizli, Outside of the US, 20070
About this study
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.
Read the detailed 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.
- Conditions
- Covid19, Endoplasmic Reticulum Stress
- Being tested
- Serum protein level analysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum protein level analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: Serum protein level analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Secondary outcomes (1)
Determination of the correlations between laboratory parameters, clinical parameters and radiological parameters
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start16 Apr 2020
- Primary completion1 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University, Acibadem University
- Responsible party
- Principal investigator, Ramazan Sbirli, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628637
- Sponsor's protocol ID
- Clinical-2
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High GRP78 Levels in Covid-19 Infection: A Case-Control Study
- ClinicalTrials.gov ID
- NCT04628637
- Acronym / sponsor ID
- Clinical-2
- Conditions
- Covid19, Endoplasmic Reticulum Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University, Acibadem University
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Serum protein level analysisInclusion 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 |
| Covid-19 (-) Pneumonia Group | – | Other: Serum protein level analysisInclusion 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 |
| Covid-19 Infection Group | – | Other: Serum protein level analysisThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (26 listed)
- Diagnosis of kidney and liver failure,
- Acute pulmonary embolism,
- Chronic inflammatory disease history (rheumatological disease, autoimmune disease),
- Pregnancy,
- Presence of any cancer diagnosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum protein level analysisSerum 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. | Other | Control Group, Covid-19 (-) Pneumonia Group, Covid-19 Infection Group |
Primary outcome
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.
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.
1 secondary outcome
Determination of the correlations between laboratory parameters, clinical parameters and radiological parameters
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: Undecided. There is no plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Endoplasmic Reticulum Stress, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.