NCT05672810

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 1, 2023

Last Update Submit

January 4, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mortality

    Till study completion, an average of 4 months

  • Need for Mechanical ventilation

    Till study completion, an average of 4 months

Interventions

Blood venous sample

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, +2, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Eman B AbdelFattah

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of chest diseases- Ain Shams University- Cairo- Egypt

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 5, 2023

Study Start

April 1, 2020

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication maybe shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3 months after publication
Access Criteria
Through the primary investigator e-mail to other interested researchers

Locations