Clinical Trial on Pneumonia, Covid19, Surfactant Protein Deficiency - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- Outside Of The US
  - Denizli, Outside Of The US, Turkey, 20070
    - Aylin Koseler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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.

Once these subjects were assessed in accordance with the inclusion and exclusion criteria. Patients who were diagnosed with Covid-19 infection according to WHO guideline as a result of clinical evaluation in the emergency department and whose diagnosis was confirmed by RT-PCR were included 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 four groups as the CT (-), PCR (+) SARS-CoV-2 infection group, Covid-19 (+) Pneumonia Group, CT (+), PCR (-) Suspected Pneumonia Group and Healthy group (Control Group).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 months
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 .	2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafkas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Actual)

November 2, 2020

Study Completion (Actual)

November 2, 2020

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)