Covid19NCT04618861

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

An observational study of Covid19 and Pneumonia, run by Kafkas University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, Pneumonia, Surfactant Protein Deficiency
How many people: 127 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 13 Oct 2020to 2 Nov 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Adult, Older adult

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).

Who may be able to join

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.

Who cannot join

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

Show all 23Show fewer

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.
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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Aylin Koseler
Denizli, Outside of the US, 20070

Other trials in Turkey (Türkiye)

About this study

Read the 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.

Conditions: Covid19, Pneumonia, Surfactant Protein Deficiency
Keywords: Serum surfactant protein D, SARS-CoV-2 infection, Pneumonia
Medical subject headings: COVID-19, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04618861
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 months
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 .
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 20202 Nov 2020

First posted6 Nov 2020
Study start13 Oct 2020
Primary completion2 Nov 2020
Study completion2 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04618861
Sponsor's protocol ID: Clinical-1
Status last verified: Nov 2020
First submitted: 3 Nov 2020
Last updated: 6 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan for sharing the patient datas.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surfactant Protein D Levels in Covid-19 Infection: Case-Control Study
ClinicalTrials.gov ID: NCT04618861
Acronym / sponsor ID: Clinical-1
Conditions: Covid19, Pneumonia, Surfactant Protein Deficiency
Keywords: Serum surfactant protein D, SARS-CoV-2 infection, Pneumonia
Study type: Observational
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Kafkas UniversityUniversity, hospital or other
Study start: 13 Oct 2020 (actual)
Primary completion: 2 Nov 2020 (actual)
Study completion: 2 Nov 2020 (actual)
First posted: 6 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Age groups: Adult, Older adult
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).

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (23 listed)

diagnosis of kidney or liver failure
acute pulmonary embolism
chronic inflammatory disease history (rheumatological disease, autoimmune disease),
pregnancy
presence of any cancer diagnosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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 .

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
Individual participant dataSharing planned: No. There is no plan for sharing the patient datas.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Pneumonia, run by Kafkas University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Meassuring the serum surfactant protein D levels in patient who have Covid-19 infection or pneumonia. (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04618861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.