RDW, Platelet Kinetics and Survival Outcome in Covid-19 Hospitalized Patients.

NCT06755658 | Active Not Recruiting

• 1 other identifier: 16526/23-08-2023
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective, non-interventional nor experimental study conducted at the General Hospital of Athens "Sismanoglio - A. Fleming / A. Fleming Hospital Unit" in hospitalized covid-19 patients who will be tested for RDW, PLT and MPV / PLT ratio, parameters in routine complete blood counts, in relation to mortality risk, during the years 2020-2021, since November 2020, when the hospital was designated, by Ministerial decision, exclusively for the treatment of covid-19 patients until June 2021, a period corresponding to the prevalence of the delta subtype, according to the local epidemiological surveillance of the National Public Health Organization of Greece. (https://eody.gov.gr/).

Conditions

Infection by SARS-COV-2

Keywords

COVID-19; SARS-COV-2; RDW; PLTs; MPV/PLT ratio; Survival; Coagulation

Outcome Measures

Primary Outcomes (1)

• Survival of patients

  Our study will examine the relationship of the red cell index RDW, platelet count PLTs and platelet index MPV/PLT ratio, with the risk of mortality in hospitalized patients with SARS-COV2, at entry, discharge, 1st week , 2nd week, as well as the total duration of hospitalization. There are no other reports on this issue in Greece.

  1 month

Study Arms (1)

A Cohort of patients with COVID-19 hospitlaized

Study admission criteria 1. Adults over 18 years old, who required hospital treatment for more than 24 hours for SARS-COV -2 infection, confirmed by molecular testing (rRT - PCR) and within one (1) month of the positive test for covid-19 diagnosis. 2. Patients directly admitted to the General Hospital Sismanoglio - A.Fleming or coming for admission and continuance of treatment for covid-19 disease, from other hospitals of 1st Health Region of Attica, where diagnosed with covid-19 disease first, with clinical information notes and laboratory data at their admission and hospitalization. 3. Patients without myelodysplastic syndrome, iron deficiency or low values of B12, folic acid.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients infected by COVID-19

You may qualify if:

• Adults over 18 years old,
• Hospital treatment for more than 24 hours for SARS-COV -2 infection, confirmed by molecular testing (rRT - PCR) and within one (1) month of the positive test for covid-19 diagnosis.

You may not qualify if:

• Patients with myelodysplastic syndrome, iron deficiency or low values of B12, folic acid.

Sponsors & Collaborators

• Sismanoglio General Hospital: lead

Study Sites (1)

Sismanoglio - Amalia Fleming General Hospital/ A.Fleming Clinical Unit

Athens, Attica, 151 27, Greece

Location

Related Publications (4)

• Karampitsakos T, Akinosoglou K, Papaioannou O, Panou V, Koromilias A, Bakakos P, Loukides S, Bouros D, Gogos C, Tzouvelekis A. Increased Red Cell Distribution Width Is Associated With Disease Severity in Hospitalized Adults With SARS-CoV-2 Infection: An Observational Multicentric Study. Front Med (Lausanne). 2020 Dec 11;7:616292. doi: 10.3389/fmed.2020.616292. eCollection 2020.

  PMID: 33363191 BACKGROUND

• Foy BH, Carlson JCT, Reinertsen E, Padros I Valls R, Pallares Lopez R, Palanques-Tost E, Mow C, Westover MB, Aguirre AD, Higgins JM. Association of Red Blood Cell Distribution Width With Mortality Risk in Hospitalized Adults With SARS-CoV-2 Infection. JAMA Netw Open. 2020 Sep 1;3(9):e2022058. doi: 10.1001/jamanetworkopen.2020.22058.

  PMID: 32965501 BACKGROUND

• Atik D, Kaya HB. EVALUATION OF THE RELATIONSHIP OF MPV, RDW AND PVI PARAMETERS WITH DISEASE SEVERITY IN COVID-19 PATIENTS. Acta Clin Croat. 2021 Mar;60(1):103-114. doi: 10.20471/acc.2021.60.01.15.

  PMID: 34588729 BACKGROUND

• Azab B, Torbey E, Singh J, Akerman M, Khoueiry G, McGinn JT, Widmann WD, Lafferty J. Mean platelet volume/platelet count ratio as a predictor of long-term mortality after non-ST-elevation myocardial infarction. Platelets. 2011;22(8):557-66. doi: 10.3109/09537104.2011.584086. Epub 2011 Jun 30.

  PMID: 21714700 BACKGROUND

MeSH Terms

Conditions

COVID-19; Thrombosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Despoina Georgiadou, MD

  Sismanogleio Hospital, Sismanogliou 1, Marousi 151 26, Athens, Greece. Amalia Fleming Clinical Unit/ Hematology Department, 25 Martiou, 14, Melissia, 15127, Athens,Greece.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, HEMATOLOGIST

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: November 1, 2021
• Primary Completion: February 1, 2025
• Study Completion: May 30, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: By 30 June uploaded on ClinicalTrials.org

Locations

GR (1)