Surfactant Protein D Levels in Covid-19 Infection: Case-Control Study

Sponsor

Kafkas University (Other)

Overall Status

Completed

CT.gov ID

NCT04618861

Collaborator

(none)

127

Enrollment

Location

Actual Duration (Days)

193.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Covid19 Pneumonia Surfactant Protein Deficiency

Detailed Description

This study aims to provide some insight into the variation of SD-D 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. Subjects will assessed in accordance with the inclusion and exclusion criteria, they were divided into four groups as the CT (-), PCR (+) SARS-CoV-2 infection group, SARS-CoV-2 (+) Pneumonia Group, CT (+), PCR (-) Suspected Pneumonia Group and Healthy group (Control Group). Demographic data, medical history, vital findings (fever, blood pressure, sPO2), laboratory findings (complete blood count; C-reactive protein (CRP), D-dimer, Ferritin and hsTnT parameters) and radiological findings, time to onset of symptoms, Comorbid diseases, hospitalization location of the patients (service or ICU), clinical scores, CT severity scores will determine. SP-D level will analyze by the Enzyme-Linked Immunosorbent Assay (ELISA) method.

Study Design

Study Type:

Observational

Actual Enrollment :

127 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Surfactant Protein D Levels in Covid-19 Infection: Case-Control Study

Actual Study Start Date :

Oct 13, 2020

Actual Primary Completion Date :

Nov 2, 2020

Actual Study Completion Date :

Nov 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Control Group This cohort involved the volunteers who had no known acute, subacute or chronic disease history, who did not suffer from any infection in the last fortnight, who were not on a particular medication, who presented to the ED with reasons other than infectious complaints, and who gave 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, and history of cerebrovascular disease. In addition, the patients whose CT imagings were compatible with Covid-19 pneumonia but whose PCR tests were negative were also excluded from the study.
CT (+), PCR (-) Covid-19 Suspected Pneumonia Group This group consisted of patients who applied to the emergency department with symptoms of Covid-19, whose thorax CT according to RSNAEC criteria showed typical Covid-19 pneumonia findings, but whose RT-PCR test was negative in the swab sample taken in the emergency room. 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, and history of cerebrovascular disease. In addition, the patients whose CT imagings were compatible with Covid-19 pneumonia but whose PCR tests were negative were also excluded from the study.
CT (+), Covid-19 Pneumonia Group This cohort consisted of the patients (a) who applied to the emergency department with SARS-CoV-2 symptoms and was diagnosed with SARS-CoV-2 infection according to WHO guideline (13) (b) whose CT imagings were compatible with SARS-CoV-2 pneumonia in accordance with the Radiological Society of North America Expert Consensus (RSNAEC) criteria (14), (c) whose nasopharyngeal swab samples taken in the ED were positive for RT-PCR, and (d) who gave their informed 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, and history of cerebrovascular disease. In addition, the patients whose CT imagings were compatible with Covid-19 pneumonia but whose PCR tests were negative were also excluded from the study.
CT (-), PCR (+) Covid-19 infection group This cohort included the patients (a) who presented to the Covid-19 outpatient polyclinic of the ED with pneumonia symptoms, (b) whose CT imaging's were compatible with Covid-19 pneumonia in accordance with the RSNAEC criteria and whose PCR tests were positive, (c) whose SARS-CoV-2 PCR tests were positive as a result of contact tracing, and (d) who presented 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, and history of cerebrovascular disease. In addition, the patients whose CT imagings were compatible with Covid-19 pneumonia but whose PCR tests were negative were also excluded from the study.

Outcome Measures

Primary Outcome Measures

Meassuring the serum surfactant protein D levels in patient who have Covid-19 infection or pneumonia. [2 months]
First primary outcome is determining the serum surfactant protein D level changes in patient who have Covid-19 infection or pneumonia aganist healty controls.
Analyzing the correlations between serum surfactant protein D levels and demographic,laboratory, clinical and radiological datas. [2 months]
Determining the correlation between between serum surfactant protein D levels and demographic datas (age,gender), medical history, vital findings (fever, blood pressure, sPO2), laboratory findings (complete blood count; C-reactive protein (CRP), D-dimer, Ferritin and hsTnT parameters) and radiological findings, time to onset of symptoms, Comorbid diseases, hospitalization location of the patients (service or ICU), clinical scores (PSI and CURB65 scores), CT severity scores .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

For patients;

Inclusion Criteria:

who presented to the Covid-19 outpatient polyclinic of the ED with pneumonia symptoms,
whose CT imaging's were compatible with Covid-19 pneumonia in accordance with the RSNAEC criteria and whose PCR tests were positive,
whose SARS-CoV-2 PCR tests were positive as a result of contact tracing,
who presented to the ED for further examination.
who gave their written consent to participate in the study.
Giving written consent to participate in the study.

Exclusion Criteria:

diagnosis of kidney or 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.
the patients whose CT imagings were compatible with Covid-19 pneumonia but whose PCR tests were negative were also excluded from the study.

For control group Inclusion Criteria

no known acute, subacute or chronic disease history
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 written consent to participate in the study.

Exclusion Criteria:

diagnosis of kidney or 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.