COVID 19NCT06968156
The Effect of Monocyte Values Accompanied by Lymphopenia on the Prognosis of Patients Diagnosed With COVID-19
An observational study of COVID 19 and Lymphopenia Due to COVID-19, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19, Lymphopenia Due to COVID-19, Monocyte
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted among patients admitted to the intensive care unit of a tertiary hospital.
Who may be able to join
- 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
Who cannot join
- Those with a negative PCR test
- Aged 18 and under
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul
About this study
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.
- Conditions
- COVID 19, Lymphopenia Due to COVID-19, Monocyte
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group monocytopenia | Not described | |
| Group control | Not described | |
| Group monocytosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Mar 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naime Yalçın, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968156
- Sponsor's protocol ID
- KAEK/2021.04.142
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Monocyte Values Accompanied by Lymphopenia on the Prognosis of Patients Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT06968156
- Acronym / sponsor ID
- KAEK/2021.04.142
- Conditions
- COVID 19, Lymphopenia Due to COVID-19, Monocyte
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 13 May 2025 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group monocytopenia | – | – |
| Group control | – | – |
| Group monocytosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted among patients admitted to the intensive care unit of a tertiary hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Those with a negative PCR test
- Aged 18 and under
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prognostic course, rate of mortality
Time frame: through study completion, an average of 5 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID 19 and Lymphopenia Due to COVID-19, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognostic course, rate of mortality (time frame: through study completion, an average of 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.