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

• Conditions: Covid19
• Interventions: Other: Observation

• Registration Number: NCT04708912
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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).

Detailed 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.

Study Timeline

• Study Start: 2020-12-15
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24
• Primary Completion: 2021-03-30
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Observation	Mild-Moderate COVID-19
2	Observation	Severe COVID-19
3	Observation	Convalsent (COVID-19)

Primary Outcome Measures

Name	Time	Method
Determination of peripheral blood RNA microarray assay	First day	Four study groups, microarray Analysis .
Determination of nasopharunx Microbiota analysis	1st day	Four study groups, metagenomic analysis, to determine abundance and decrease of some species.
Determination of in vitro cytokines production	First day	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)
Determination of peripheral blood cytometry	First day	Four study groups, peripheral blood cytometry; CD3, CD4, CD8, and CD45 rates.
Relation between study parameters	First day 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)

Trial Locations

Locations (1)

Bakirkoy Dr.sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey