NCT06968156

Brief Summary

Recent studies have shown that lymphopenia with cytokine storm syndrome is frequently found in COVID-19 patients. These features may suggest that the modified immune system plays a key role in determining disease progression. Lymphopenia or lymphocytopenia is a condition in which the number of lymphocytes in the blood is low. Although T cells can be increased at the onset of COVID-19, these patients tend to have low lymphocyte counts, which is associated with increased COVID-19 severity. Thus, individuals who died of COVID-19 have been shown to have significantly lower lymphocyte levels than survivors. There is evidence that myeloid cells play a role in the pathophysiology of coronavirus infection, either directly as virus targets or indirectly as effectors of cytokine release syndrome. Monocytes are innate hematopoietic cells that maintain vascular homeostasis and provide early responses to pathogens during acute infections. The role of monocytes and macrophages in the resolution of inflammation has also been emphasized as an important component of the response to SARS-CoV-2. Accordingly, it was investigated whether the change observed in blood monocyte levels was an effective parameter in the prognosis process in Covid-19 cases with lymphopenia, considering that monocyte levels could be useful as a guide in the course of the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

March 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 1, 2025

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • prognostic course, rate of mortality

    The parameters examined will be survival and exitus status, age, weight in kilograms, height in centimeters, weight and height will be combined to report BMI in kg/m\^2, gender, presence of additional disease, ferritin, D-dimer, C-reactive protein, lactate dehydrogenase, procalcitonin, fibrinogen, hemoglobin, leukocyte, platelet, neutrophil, eosinophil, basophil, monocyte, lymphocyte levels measured during admission to the intensive care unit. Lymphocyte-monocyte ratio, neutrophil-lymphocyte ratio and platelet-lymphocyte ratio will be obtained from the detected data. The existing O2 requirement at admission to the intensive care unit was recorded retrospectively as fractional inspired oxygen (FiO2) value, the source of oxygen support and the existing Covid-19 treatment. The hemodialysis, vasopressor and intubation requirement that developed during the hospitalization and the exitus status during hospitalization were evaluated.

    through study completion, an average of 5 month

Study Arms (3)

Group monocytopenia

Group control

Group monocytosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study was conducted among patients admitted to the intensive care unit of a tertiary hospital.

You may qualify if:

  • Patients over the age of 18
  • Male and female of both genders
  • Admitted to the intensive care unit
  • Diagnosed with Covid-19 with lymphopenia
  • Patients with confirmed COVID-19 diagnosis in polymerase chain reaction (PCR) tests performed on nasopharyngeal swab samples

You may not qualify if:

  • Those with a negative PCR test
  • Aged 18 and under

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation specialist

Study Record Dates

First Submitted

May 1, 2025

First Posted

May 13, 2025

Study Start

March 1, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations