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NCT Number: NCT05672810

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

serum level of Ferritin and D-dimer

Diagnostic Test

Blood venous sample

Primary outcomes

  1. Mortality

    Time frame: Till study completion, an average of 4 months

  2. Need for Mechanical ventilation

    Time frame: Till study completion, an average of 4 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Correlation Between the Serum Level of Ferritin and D-dimer and the Severity of COVID-19 Infection

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2023
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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