NCT07244731

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

October 1, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

COVID-19Red Cell Distribution Width (RDW)MortalityIntubationPrognostic marker

Outcome Measures

Primary Outcomes (1)

  • discharge / death

    discharge from the intensive care unit / death during intensive care follow-up

    From admission to the intensive care unit until ICU discharge or death, assessed up to 30 days.

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Ankara, 06340, 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 Officials

  • Mustafa Necmettin Ünal

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology

Study Record Dates

First Submitted

October 1, 2025

First Posted

November 24, 2025

Study Start

September 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations