COVID - 19RDW-Covıd-19NCT07244731
The Prognostic Role of Red Blood Cell Distribution (RDW) in Severe COVID-19 Patients
An observational study of COVID - 19 and Prognosis, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the prognostic significance of erythrocyte distribution width (RDW) in severe and critically ill COVID-19 patients followed in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID - 19, Prognosis, ICU
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Jun 2025
- 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: Ministry of Health of the Republic of Turkey Ankara University Ibn-i-Sina Hospital Anaesthesiology and Resuscitation Department Patients admitted to the COVID-19 intensive care unit
Who may be able to join
- Patients aged 18 years and older
- Severe and critically ill COVID-19 patients (PCR test positivity of COVID)
- Patients who have been monitored in the intensive care unit for at least 3 days
- Patients without haematological malignancies
Who cannot join
- Patients under 18 years of age
- Those with haematological malignancies (as this may affect RDW levels)
- Patients who died within 3 days of admission to intensive care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Evaluation of Red Blood Cell Distribution Width (RDW) in Severe and Critical COVID-19 Patients Monitored in the Intensive Care Unit
The aim of this study was to evaluate the prognostic significance of erythrocyte distribution width (RDW) in severe and critically ill COVID-19 patients followed in the intensive care unit (ICU). RDW is a parameter that measures the heterogeneity in red blood cell size and is associated with the pathophysiological processes of COVID-19, such as systemic inflammation, oxidative stress, and erythropoiesis disorders. This study investigated the relationship between RDW and the need for intubation and mortality, and its utility as a prognostic marker in COVID-19 patients.
Read the detailed description
Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus. According to official figures from the World Health Organization, the COVID-19 pandemic has sickened 780 million people worldwide and caused more than 7 million deaths.
Common symptoms of COVID-19 include fever, cough, and shortness of breath. Symptoms such as headache, sore throat, runny nose, muscle and joint pain, extreme fatigue, new-onset loss of smell and taste, and diarrhea may also occur. While the disease can be asymptomatic, severe cases can develop pneumonia, severe acute respiratory infection, multiple organ failure, and death. Predicting high risk in patients with COVID-19 has the potential to reduce mortality and morbidity by enabling early transfer of patients to intensive care units and planning appropriate treatment. For this purpose, numerous studies have been conducted to determine whether different markers can be used in addition to risk scores such as APACHE and SOFA, which are currently used in intensive care units. These markers include increased neutrophil and platelet counts, decreased lymphocyte counts, and elevated levels of B-type natriuretic peptide (BNP), blood urea nitrogen (BUN), creatine kinase (CK), bilirubin, interleukin-6 (IL-6), c-reactive protein (CRP), procalcitonin, ferritin, alanine aminotransferase (ALT), albumin, and lactate dehydrogenase (LDH). RDW (red blood cell distribution width), a measure of variation in red blood cell size, has traditionally been used in the diagnosis of various hematological conditions. In recent years, it has also been shown to be a potential marker of inflammation.
Increased proinflammatory activity and hypoxia impair erythropoiesis, leading to an increase in red cell distribution width (RDW) and changes in hematocrit. Increased RDW has been associated with poor prognosis in other critical illnesses, such as sepsis and cardiovascular disease. In COVID-19, viral inflammation can affect erythrocyte production and turnover, leading to an increase in RDW. Increased RDW increases proportionally with the degree of systemic inflammation and can therefore be a marker of disease severity. Higher RDW values at hospitalization have been associated with increased mortality and the need for intensive care. A meta-analysis of multiple studies has shown that high RDW is a strong predictor of mortality in COVID-19 patients. This meta-analysis suggests that RDW can be used as an early warning indicator to identify patients at high risk for severe disease and adverse clinical outcomes. Other research supports the use of RDW as a biomarker in COVID-19 and reinforces the role of RDW as a general marker of physiological stress/disease severity. RDW, a low-cost parameter included in the standard complete blood count, can be easily integrated into clinical practice, contributing to the early identification of high-risk COVID-19 patients and facilitating the planning of timely and appropriate medical interventions.
The aim of this study is to investigate the relationship between RDW values at admission and the need for intubation in severely ill and critically ill patients admitted to COVID-19 intensive care unit by analyzing the time course of RDW. Furthermore, the relationship between RDW and other laboratory and clinical parameters will also be investigated.
Materials and Methods: This retrospective study was conducted using data from patients admitted to the COVID-19 intensive care unit at Ankara University Ibn-i Sina Research and Application Hospital between April 2021 and August 2024. Among 758 patients admitted to the intensive care unit (ICU) due to COVID-19 between the specified dates and who met the World Health Organization's severe and critically ill COVID-19 criteria, 360 patients were randomly selected.
Patients' demographic characteristics (age, gender, vaccination status), comorbidities, length of stay in the ICU, need for intubation, laboratory parameters (RDW, hemoglobin, platelet count, leukocyte count, neutrophil/lymphocyte (N/L) ratio, CRP, procalcitonin, interleukin-6, etc.), and ICU severity scores (APACHE II and SOFA) were recorded. RDW values were recorded for five consecutive days, starting from the first day of ICU admission.
For statistical analyses, the Mann-Whitney U test was used to compare two independent groups, the Chi-square test for categorical variables, and the Two-Way Repeated Measurement ANOVA for repeated measurements. A P value of <0.05 was considered statistically significant. The prognostic value of RDW and the optimal cut-off value were determined using ROC analysis.
- Conditions
- COVID - 19, Prognosis, ICU
- Keywords
- COVID-19, Red Cell Distribution Width (RDW), Mortality, Intubation, Prognostic marker
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
discharge / death
discharge from the intensive care unit / death during intensive care follow-up
Measured: From admission to the intensive care unit until ICU discharge or death, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Sep 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
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.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Güneş Yeşilova, MD, Ankara University
- Investigators
- Mustafa Necmettin Ünal, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244731
- Sponsor's protocol ID
- HTCGNSTEZ
- Other IDs
- İ10-808-24
- Acronym
- RDW-Covıd-19
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Evaluation of Red Blood Cell Distribution Width (RDW) in Severe and Critical COVID-19 Patients Monitored in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07244731
- Acronym / sponsor ID
- RDW-Covıd-19 / HTCGNSTEZ
- Conditions
- COVID - 19, Prognosis, ICU
- Keywords
- COVID-19, Red Cell Distribution Width (RDW), Mortality, Intubation, Prognostic marker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 24 Nov 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.
The aim of this study was to evaluate the prognostic significance of erythrocyte distribution width (RDW) in severe and critically ill COVID-19 patients followed in the intensive care unit (ICU). RDW is a parameter that measures the heterogeneity in red blood cell size and is associated with the pathophysiological processes of COVID-19, such as systemic inflammation, oxidative stress, and erythropoiesis disorders. This study investigated the relationship between RDW and the need for intubation and mortality, and its utility as a prognostic marker in COVID-19 patients.
Detailed description
Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus. According to official figures from the World Health Organization, the COVID-19 pandemic has sickened 780 million people worldwide and caused more than 7 million deaths.
Common symptoms of COVID-19 include fever, cough, and shortness of breath. Symptoms such as headache, sore throat, runny nose, muscle and joint pain, extreme fatigue, new-onset loss of smell and taste, and diarrhea may also occur. While the disease can be asymptomatic, severe cases can develop pneumonia, severe acute respiratory infection, multiple organ failure, and death. Predicting high risk in patients with COVID-19 has the potential to reduce mortality and morbidity by enabling early transfer of patients to intensive care units and planning appropriate treatment. For this purpose, numerous studies have been conducted to determine whether different markers can be used in addition to risk scores such as APACHE and SOFA, which are currently used in intensive care units. These markers include increased neutrophil and platelet counts, decreased lymphocyte counts, and elevated levels of B-type natriuretic peptide (BNP), blood urea nitrogen (BUN), creatine kinase (CK), bilirubin, interleukin-6 (IL-6), c-reactive protein (CRP), procalcitonin, ferritin, alanine aminotransferase (ALT), albumin, and lactate dehydrogenase (LDH). RDW (red blood cell distribution width), a measure of variation in red blood cell size, has traditionally been used in the diagnosis of various hematological conditions. In recent years, it has also been shown to be a potential marker of inflammation.
Increased proinflammatory activity and hypoxia impair erythropoiesis, leading to an increase in red cell distribution width (RDW) and changes in hematocrit. Increased RDW has been associated with poor prognosis in other critical illnesses, such as sepsis and cardiovascular disease. In COVID-19, viral inflammation can affect erythrocyte production and turnover, leading to an increase in RDW. Increased RDW increases proportionally with the degree of systemic inflammation and can therefore be a marker of disease severity. Higher RDW values at hospitalization have been associated with increased mortality and the need for intensive care. A meta-analysis of multiple studies has shown that high RDW is a strong predictor of mortality in COVID-19 patients. This meta-analysis suggests that RDW can be used as an early warning indicator to identify patients at high risk for severe disease and adverse clinical outcomes. Other research supports the use of RDW as a biomarker in COVID-19 and reinforces the role of RDW as a general marker of physiological stress/disease severity. RDW, a low-cost parameter included in the standard complete blood count, can be easily integrated into clinical practice, contributing to the early identification of high-risk COVID-19 patients and facilitating the planning of timely and appropriate medical interventions.
The aim of this study is to investigate the relationship between RDW values at admission and the need for intubation in severely ill and critically ill patients admitted to COVID-19 intensive care unit by analyzing the time course of RDW. Furthermore, the relationship between RDW and other laboratory and clinical parameters will also be investigated.
Materials and Methods: This retrospective study was conducted using data from patients admitted to the COVID-19 intensive care unit at Ankara University Ibn-i Sina Research and Application Hospital between April 2021 and August 2024. Among 758 patients admitted to the intensive care unit (ICU) due to COVID-19 between the specified dates and who met the World Health Organization's severe and critically ill COVID-19 criteria, 360 patients were randomly selected.
Patients' demographic characteristics (age, gender, vaccination status), comorbidities, length of stay in the ICU, need for intubation, laboratory parameters (RDW, hemoglobin, platelet count, leukocyte count, neutrophil/lymphocyte (N/L) ratio, CRP, procalcitonin, interleukin-6, etc.), and ICU severity scores (APACHE II and SOFA) were recorded. RDW values were recorded for five consecutive days, starting from the first day of ICU admission.
For statistical analyses, the Mann-Whitney U test was used to compare two independent groups, the Chi-square test for categorical variables, and the Two-Way Repeated Measurement ANOVA for repeated measurements. A P value of <0.05 was considered statistically significant. The prognostic value of RDW and the optimal cut-off value were determined using ROC analysis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ministry of Health of the Republic of Turkey Ankara University Ibn-i-Sina Hospital Anaesthesiology and Resuscitation Department Patients admitted to the COVID-19 intensive care unit
Key inclusion criteria (4 listed)
- Patients aged 18 years and older
- Severe and critically ill COVID-19 patients (PCR test positivity of COVID)
- Patients who have been monitored in the intensive care unit for at least 3 days
- Patients without haematological malignancies
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- Those with haematological malignancies (as this may affect RDW levels)
- Patients who died within 3 days of admission to intensive care
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
discharge / death
Time frame: From admission to the intensive care unit until ICU discharge or death, assessed up to 30 days.
discharge from the intensive care unit / death during intensive care follow-up
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 24 Nov 2025.
- 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.
Mustafa Necmettin Ünal study director
Ankara University
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 Prognosis, run by Ankara University 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 4 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: finished, as of the sponsor's last update on 24 Nov 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?
discharge / death (time frame: From admission to the intensive care unit until ICU discharge or death, assessed up to 30 days.). 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 24 Nov 2025.