Covid198796NCT04708912
Nasopharynx Microbiota Component and in Vitro Cytokines Production in Coronavirus Disease (COVID-19)
An observational study of Covid19, run by Başakşehir Çam & Sakura City Hospital at 2 sites in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Observation
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 1 Apr 2021
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (18-80 yerars ), both gender
Who may be able to join
- Ability to give a written consent
Who cannot join
- In ability to give a written consent
- Using of medications that affect the results of study parameters
- Presence of malignancy or tuberculosis
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bakirkoy Dr.sadi Konuk Training and Research Hospital
Istanbul, 34100
- Recruiting
Bakirkoy Dr.sadi Konuk Training and Research Hospital
Istanbul
About this study
Official title: TUSEB-Nasopharynx Microbiota Component and in Vitro Cytokines Production in Coronavirus Disease (COVID-19)
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).
Read the 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.
- Conditions
- Covid19
- Being tested
- Observation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
The study parameters will be obtained at the time of recuirement (Basal)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Mild-Moderate COVID-19 Receives: Other: Observation | |
| 2 | Severe COVID-19 Receives: Other: Observation | |
| 3 | Convalsent (COVID-19) Receives: Other: Observation | |
| 4 | Healthy persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of peripheral blood RNA microarray assay
Four study groups, microarray Analysis .
Measured: First day
Determination of nasopharunx Microbiota analysis
Four study groups, metagenomic analysis, to determine abundance and decrease of some species.
Measured: 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)
Measured: First day
Determination of peripheral blood cytometry
Four study groups, peripheral blood cytometry; CD3, CD4, CD8, and CD45 rates.
Measured: 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)
Measured: First day parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start15 Dec 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Hursitoglu, Başakşehir Çam & Sakura City Hospital
- Investigators
- Mehmet Hursitoglu, MD, Principal investigator, Basaksehir Cam and sakura Sehir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708912
- Sponsor's protocol ID
- 8796
- Acronym
- 8796
- Status last verified
- Mar 2021
- First submitted
- 11 Jan 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Microbiota and viral infections
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TUSEB-Nasopharynx Microbiota Component and in Vitro Cytokines Production in Coronavirus Disease (COVID-19)
- ClinicalTrials.gov ID
- NCT04708912
- Acronym / sponsor ID
- 8796 / 8796
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 14 Jan 2021 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: ObservationMild-Moderate COVID-19 |
| 2 | – | Other: ObservationSevere COVID-19 |
| 3 | – | Other: ObservationConvalsent (COVID-19) |
| 4 | – | –Healthy persons |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18-80 yerars ), both gender
Key inclusion criteria (1 listed)
- Ability to give a written consent
Key exclusion criteria (3 listed)
- In ability to give a written consent
- Using of medications that affect the results of study parameters
- Presence of malignancy or tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationThe study parameters will be obtained at the time of recuirement (Basal) | Other | 1, 2, 3 |
Primary outcome
Determination of peripheral blood RNA microarray assay
Time frame: First day
Four study groups, microarray Analysis .
Determination of nasopharunx Microbiota analysis
Time frame: 1st day
Four study groups, metagenomic analysis, to determine abundance and decrease of some species.
Determination of in vitro cytokines production
Time frame: 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
Time frame: First day
Four study groups, peripheral blood cytometry; CD3, CD4, CD8, and CD45 rates.
Relation between study parameters
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Results publicationMicrobiota and viral infections
- Individual participant dataSharing planned: No
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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.
Mehmet Hursitoglu, MD principal investigator
Basaksehir Cam and sakura Sehir Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Başakşehir Çam & Sakura City Hospital at 2 sites 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Hursitoglu, MD (+902129096000 ext. 20527, mehmet.hursitoglu@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of peripheral blood RNA microarray assay (time frame: First day). The study lists 5 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 NCT04708912, which also lists 1 linked publication.
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 24 Mar 2021.