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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Ankara University

    Ankara, Ankara, 06340

Other trials in Turkey (Türkiye)

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.

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.

  1. 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.

  1. First posted24 Nov 2025
  2. Study start1 Sep 2024
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2025

Resources

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)
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

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.

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