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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618861
• Other study ID #: Clinical-1
• Status: Completed
• Start date: October 13, 2020
• Est. completion date: November 2, 2020

Study information

• Verified date: November 2020
• Source: Kafkas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Infection
• Pneumonia
• Protein Deficiency
• Surfactant Protein Deficiency

Locations

Country	Name	City	State
Turkey	Aylin Koseler	Denizli	Outside Of The US

Sponsors (1)

Lead Sponsor	Collaborator
Kafkas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meassuring the serum surfactant protein D levels in patient who have Covid-19 infection or pneumonia.	First primary outcome is determining the serum surfactant protein D level changes in patient who have Covid-19 infection or pneumonia aganist healty controls.	2 months
Primary	Analyzing the correlations between serum surfactant protein D levels and demographic,laboratory, clinical and radiological datas.	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 .	2 months