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Completed

NCT Number: NCT04618861

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

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Meassuring the serum surfactant protein D levels in patient who have Covid-19 infection or pneumonia.

    Time frame: 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.

  2. Analyzing the correlations between serum surfactant protein D levels and demographic,laboratory, clinical and radiological datas.

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Kafkas University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2020
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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