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

Covid19 Clinical Trial

— 8796  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04708912
• Other study ID #: 8796
• Status: Recruiting
• Start date: December 15, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2021
• Source: Basaksehir Cam & Sakura Sehir Hospital
• Contact: Mehmet Hursitoglu, MD
• Phone: +902129096000
• Email: mehmet.hursitoglu[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

The investigators will compare study parameters (basal) between mild-moderate and severe COVID-19 patients and with other study groups (i.e. convalescent and healthy controls). Nasopharunx microbiota dysbiosis, in vitro cytokines production profile, and peripheral blood flocytometric results of the four study groups will be compared.

In vitro cytokines production will be studied and compared in Nill (No antigens) and Mitojen (Cocktail of antigens) pre-prepared test tubes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Ability to give a written consent

Exclusion Criteria:

• In ability to give a written consent

• Using of medications that affect the results of study parameters

• Presence of malignancy or tuberculosis

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19

Intervention

Other:
• Observation
The study parameters will be obtained at the time of recuirement (Basal)

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr.sadi Konuk Training and Research Hospital	Istanbul
Turkey	Bakirkoy Dr.sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Cam & Sakura Sehir Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Microbiota and viral infections

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of peripheral blood RNA microarray assay	Four study groups, microarray Analysis .	First day
Primary	Determination of nasopharunx Microbiota analysis	Four study groups, metagenomic analysis, to determine abundance and decrease of some species.	1st day
Primary	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-a and tumor necrosis factor-a in Nill (no angijen) and Mitojen (Cocktails of antigens)tubes (between 4 study groups)	First day
Primary	Determination of peripheral blood cytometry	Four study groups, peripheral blood cytometry; CD3, CD4, CD8, and CD45 rates.	First day
Primary	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