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

Kafkas University

Status: Completed

Conditions: Covid19; Pneumonia; Surfactant Protein Deficiency

Study type: Observational

Funder types: Other

Identifiers

NCT04618861

Clinical-1

Details and patient eligibility

About

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. Objective of the study is to determine the serum surfactant protein D (SP-D) levels in Covid-19 pneumonia infection.

Full 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.

Enrollment: 127 patients

Sex

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

127 participants in 4 patient groups

Control Group

Description:

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

Description:

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

Description:

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

Description:

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.