Serum Level of Ferritin and D-dimer and the Severity of (COVID 19) Infection

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05672810
Collaborator
(none)
150
1
4
37.7

Study Details

Study Description

Brief Summary

Many laboratory biomarkers were used for diagnosis of COVID-19 infection; however, their accuracy to assess the severity and prognosis are still to be evaluated.

Aim: to correlate between the serum Ferritin and D-dimer levels and the severity of COVID-19 infection and its outcome (mortality, days of hospital stay, ICU admission or mechanical ventilation).

A retrospective study conducted by retrieving patients' data who were admitted to Ain Shams University Specialized Hospital - Obour branch and diagnosed with COVID-19 infection in the period from 1st of April 2020 to 31st of July 2020.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: serum level of Ferritin and D-dimer

Detailed Description

Aim of the study: to correlate between the serum level of Ferritin and D-dimer and the severity of COVID-19 infection as well as its outcome

Material and methods:

It is a retrospective study conducted by retrieving data of patients diagnosed with COVID-19 infection "PCR positive for SARS-CoV2" who were admitted to Ain Shams University Specialized Hospital - Obour branch in the period from 1st of April 2020 to 31st of July 2020.

The following data were collected from the studied patients' files:

• Demographic characteristics (age, sex, marital status, smoking status, co-morbidities), Source of infection, degree of severity of COVID-19 infection according to WHO Clinical management of COVID-19: interim guidance.

The investigations done include:

Laboratory investigations: including; (Complete blood picture, Iron profile, Liver function tests, D-dimer ("Using: using Biomerieux-VIDAS, Serial number IVD3002806, Manufactured in 2008, Marcy l'Étoile, France " "Reference range: 0-500 ng/ml") and Serum Ferritin ("using ABBOT-Architect 1000, Serial number I1SR62514, Manufactured in 2010, Chicago, Illinois, United States.""Reference range: 13-150 ng/ml" (Figure number "2") Radiological investigations: By High resolution CT chest ("Using: Toshiba 16-slice CT scanner, model number: activion 16, Manufactured in 2010, Japan") "severity scoring was done using "25-point CT severity score" Li et al, 2020". Score of 7 or less was considered as mild affection, 8-17 was considered as moderate affection and 18 or more was considered as severe affection " Saeed et al 2021"

Inclusion Criteria:

Hospitalized isolated patients "in Ain Shams University Specialized Hospital - Obour branch" with COVID-19 infection confirmed by "Polymerase chain reaction (PCR) positive for SARS-CoV2".

Exclusion Criteria:
  • COVID-19 patients with other conditions altering the serum Ferritin level; For example; iron deficiency anemia, defective intestinal absorption, internal bleeding, rheumatoid arthritis, hyperthyroidism, leukemia, Hodgkin's lymphoma, frequent blood transfusions and advanced liver disease "Child-Pugh score C".

  • COVID-19 patients with other conditions altering the serum D-dimer level; For example; known pulmonary embolism, known Deep Venous Thrombosis "DVT", pregnancy, heart failure, trauma, active malignancy, septicemia, disseminated Intra-vascular Coagulopathy "DIC".

  • The patients with any missing studied data were also excluded. Data was correlated with the clinical spectrum of severity and the patient outcome regarding: death or recovery, days of hospital stay, need for ICU admission and need for mechanical ventilation.

Study Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Correlation Between the Serum Level of Ferritin and D-dimer and the Severity of COVID-19 Infection
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Jul 31, 2020
Actual Study Completion Date :
Jul 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Mortality [Till study completion, an average of 4 months]

  2. Need for Mechanical ventilation [Till study completion, an average of 4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Hospitalized isolated patients "in Ain Shams University Specialized Hospital - Obour" with COVID-19 infection confirmed by "Polymerase chain reaction (PCR) positive for SARS-CoV2".
Exclusion Criteria:
  • • COVID-19 patients with other conditions altering the serum Ferritin level; For example; iron deficiency anemia, defective intestinal absorption, internal bleeding, rheumatoid arthritis, hyperthyroidism, leukemia, Hodgkin's lymphoma, frequent blood transfusions and advanced liver disease "Child-Pugh score C".

  • COVID-19 patients with other conditions altering the serum D-dimer level; For example; known pulmonary embolism, known Deep Venous Thrombosis "DVT", pregnancy, heart failure, trauma, active malignancy, septicemia, disseminated Intra-vascular Coagulopathy "DIC".

  • The patients with any missing studied data were also excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University Cairo Egypt +2

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Principal Investigator: Eman B AbdelFattah, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eman Badawy AbdelFattah, Associate professor of chest diseases- Ain Shams University- Cairo- Egypt, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05672810
Other Study ID Numbers:
  • FMASU MS220/2020
First Posted:
Jan 5, 2023
Last Update Posted:
Jan 5, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2023