NCT04531319

Brief Summary

COVID-19, spreading rapidly all over the world, causes serious morbidity and mortality. In severe COVID-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure. It is noteworthy that it causes lymphopenia in patients. In studies conducted, the effects of Covid-19 on the immune system were evaluated with limited parameters. In addition, no study evaluating the effect of this disease on the immune system has been published in our country.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

August 27, 2020

Last Update Submit

January 11, 2021

Conditions

Keywords

T helper cellT cytotoxic cellMonocyteNK cell

Outcome Measures

Primary Outcomes (1)

  • T cell subtype ratios

    T helper, NK cell and T cytotoxic cell ratio

    1 month

Secondary Outcomes (1)

  • Monocyte ratio

    1 month

Study Arms (2)

Case Group

Covid 19 (+) patients

Diagnostic Test: Flow cytometric analysis

Control Group

Healthy volunteers

Diagnostic Test: Flow cytometric analysis

Interventions

Flow cytometric analysis of T helper, T cytotoxic cells, NK cells and monocytes

Case GroupControl Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who admitted to the emergency department with the complaint of respiratory failure, lymphopenia in blood tests and Covid 19 (+) in the PCR tests are case group. Also healty volunteers who don't have complaint of respiratory failure, lymphopenia in blood tests and Covid 19 (-) in the PCR tests are control group.

You may qualify if:

  • Patients with Covid 19 PCR (+) results

You may not qualify if:

  • Cancer Patients
  • Patients with known immunodeficiency
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Reseach Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

  • Bi Q, Wu Y, Mei S, Ye C, Zou X, Zhang Z, Liu X, Wei L, Truelove SA, Zhang T, Gao W, Cheng C, Tang X, Wu X, Wu Y, Sun B, Huang S, Sun Y, Zhang J, Ma T, Lessler J, Feng T. Epidemiology and transmission of COVID-19 in 391 cases and 1286 of their close contacts in Shenzhen, China: a retrospective cohort study. Lancet Infect Dis. 2020 Aug;20(8):911-919. doi: 10.1016/S1473-3099(20)30287-5. Epub 2020 Apr 27.

    PMID: 32353347BACKGROUND
  • Felsenstein S, Herbert JA, McNamara PS, Hedrich CM. COVID-19: Immunology and treatment options. Clin Immunol. 2020 Jun;215:108448. doi: 10.1016/j.clim.2020.108448. Epub 2020 Apr 27.

    PMID: 32353634BACKGROUND
  • Ganji A, Farahani I, Khansarinejad B, Ghazavi A, Mosayebi G. Increased expression of CD8 marker on T-cells in COVID-19 patients. Blood Cells Mol Dis. 2020 Jul;83:102437. doi: 10.1016/j.bcmd.2020.102437. Epub 2020 Apr 13.

    PMID: 32325421BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ufuk Oguz Idiz, Assoc. Prof

    Istanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

August 27, 2020

First Posted

August 28, 2020

Study Start

August 15, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations