Nasopharynx Microbiota Component and in Vitro Cytokines Production in Coronavirus Disease (COVID-19)

NCT04708912 | Unknown

• 1 other identifier: 8796
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators will study nasopharunx microbiota composition, RNA sequences and in vitro cytokines production by peripheral blood cells of COVID-19 patients (both mild-moderate and severe cases) (comparing with convalescent patients and healthy controls).

Conditions

Covid19

Outcome Measures

Primary Outcomes (5)

• Determination of peripheral blood RNA microarray assay

  Four study groups, microarray Analysis .

  First day

• Determination of nasopharunx Microbiota analysis

  Four study groups, metagenomic analysis, to determine abundance and decrease of some species.

  1st day

• Determination of in vitro cytokines production

  IL-2, IL-7, IL-10, granulocyte-colony stimulating factor, interferon-p inducible protein 10, monocyte chemo-attracting protein 1, macrophage inflammatory protein 1-α and tumor necrosis factor-α in Nill (no angijen) and Mitojen (Cocktails of antigens)tubes (between 4 study groups)

  First day

• Determination of peripheral blood cytometry

  Four study groups, peripheral blood cytometry; CD3, CD4, CD8, and CD45 rates.

  First day

• Relation between study parameters

  determining the realtion between microbiotme dysbiosis, in vitro cytokines production and peripheral leymphocytes (CD3,CD4, CD8, and CD45) rates and the severity of COVID-19( if any)

  First day parameters

Study Arms (4)

1

Mild-Moderate COVID-19

Other: Observation

2

Severe COVID-19

Other: Observation

3

Convalsent (COVID-19)

Other: Observation

4

Healthy persons

Interventions

Observation OTHER

The study parameters will be obtained at the time of recuirement (Basal)

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults (18-80 yerars ), both gender

You may qualify if:

• Ability to give a written consent

You may not qualify if:

• In ability to give a written consent
• Using of medications that affect the results of study parameters
• Presence of malignancy or tuberculosis

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (2)

Bakirkoy Dr.sadi Konuk Training and Research Hospital

Istanbul, 34100, Turkey (Türkiye)

RECRUITING

Bakirkoy Dr.sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Microbiota and viral infections

  RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Microbiota and RNA sequencing

MeSH Terms

Conditions

COVID-19

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Mehmet Hursitoglu, MD

  Basaksehir Cam and sakura Sehir Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Hursitoglu, MD

CONTACT

+902129096000; mehmet.hursitoglu@sbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: December 15, 2020
• Primary Completion: March 30, 2021
• Study Completion: April 1, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)