COVID-19NCT05672810
Serum Level of Ferritin and D-dimer and the Severity of (COVID 19) Infection
An observational study of COVID-19, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- serum level of Ferritin and D-dimer
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Hospitalized isolated patients "in Ain Shams University Specialized Hospital - Obour" with COVID-19 infection confirmed by "Polymerase chain reaction (PCR) positive for SARS-CoV2".
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between the 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- serum level of Ferritin and D-dimer
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum level of Ferritin and D-dimerDiagnostic test
Blood venous sample
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Till study completion, an average of 4 months
Need for Mechanical ventilation
Measured: Till study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Apr 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Badawy AbdelFattah, Ain Shams University
- Investigators
- Eman B AbdelFattah, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672810
- Sponsor's protocol ID
- FMASU MS220/2020
- Status last verified
- Jan 2023
- First submitted
- 1 Jan 2023
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication maybe shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Serum Level of Ferritin and D-dimer and the Severity of COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05672810
- Acronym / sponsor ID
- FMASU MS220/2020
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Hospitalized isolated patients "in Ain Shams University Specialized Hospital - Obour" with COVID-19 infection confirmed by "Polymerase chain reaction (PCR) positive for SARS-CoV2".
Key exclusion criteria (3 listed)
- • 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".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum level of Ferritin and D-dimerBlood venous sample | Diagnostic test | – |
Primary outcome
Mortality
Time frame: Till study completion, an average of 4 months
Need for Mechanical ventilation
Time frame: Till study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication maybe shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman B AbdelFattah principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Till study completion, an average of 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.