COVID-19NCT05650944
How Important Are Hematological Parameters in the Prognosis of Severe Covid-19 Patients?
An observational study of COVID-19, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to reveal the treatment and prognostic values by evaluating the differences in hematological parameters and indices, especially in dead Covid-19 cases. Material Method: It is planned to retrospectively examine the hemogram parameters of 125 male, 44 female and 169 critical Covid-19 patients hospitalized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hemogram
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study had 169 patients in all, including 44 women and 125 males
Who may be able to join
- Patients over the age of 18
- Critical patients taken to intensive care
- The length of stay in the ICU is more than 24 hours
Who cannot join
- 1) Patients under 18 years of age (2) Patients with hematological malignancies (3) The length of stay in the ICU is less than 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Infectious Disease and Clinical Microbiology
It is aimed to reveal the treatment and prognostic values by evaluating the differences in hematological parameters and indices, especially in dead Covid-19 cases.
Material Method: It is planned to retrospectively examine the hemogram parameters of 125 male, 44 female and 169 critical Covid-19 patients hospitalized between 01.03.2020 and 31.12.2021. Subjects were divided into 2 groups as deceased (77) and living (92) patients according to demographic data such as age and gender.
Statistical evaluation: All analyzes were SPSS 25.0, Kolmogorov Smirnov test was used to determine distribution, median and interquartile range (Tukey's Hinges Percentile) were used to summarize variables. The differences between the Independent-Samples Mann Whitney U Test and the data of the patient groups and the optimal cut-off values, sensitivity and specificity values will be determined by ROC analysis. It will be considered statistically significant when the p value is below 0.05 (with the two-tailed test)
Read the detailed description
The aim of this study is to examine the effectiveness of routine laboratory complete blood count parameters and rates as diagnostic and prognostic criteria in severe COVID-19.
- Conditions
- COVID-19
- Being tested
- Hemogram
- Keywords
- Hemogram, NLR, MPV/PLT, MPV/PCT
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemogramDiagnostic test
Sysmex XN-1000 hematological analyzer
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 Survivor groups | Covid-19 survivor groups are hematological parameters Receives: Diagnostic Test: Hemogram | |
| Covid-19 Non-survivor groups | Hematological parameters in patients with severe COVID-19 who have died. Receives: Diagnostic Test: Hemogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematological parameters in the prognosis of severe Covid-19 patients.
Hemogram values of the deceased and surviving patients participating in the study were compared.
Measured: 2020-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Mar 2020
- Primary completion31 Dec 2021
- Study completion30 Sep 2022
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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan Gozukucuk, Hisar Intercontinental Hospital
- Investigators
- Ramazan Gozukucuk, Study chair, Istanbul Galata Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650944
- Sponsor's protocol ID
- HisarIH-125
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After accepted by Journal.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Infectious Disease and Clinical Microbiology
- ClinicalTrials.gov ID
- NCT05650944
- Acronym / sponsor ID
- HisarIH-125
- Conditions
- COVID-19
- Keywords
- Hemogram, NLR, MPV/PLT, MPV/PCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 14 Dec 2022 (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.
It is aimed to reveal the treatment and prognostic values by evaluating the differences in hematological parameters and indices, especially in dead Covid-19 cases.
Material Method: It is planned to retrospectively examine the hemogram parameters of 125 male, 44 female and 169 critical Covid-19 patients hospitalized between 01.03.2020 and 31.12.2021. Subjects were divided into 2 groups as deceased (77) and living (92) patients according to demographic data such as age and gender.
Statistical evaluation: All analyzes were SPSS 25.0, Kolmogorov Smirnov test was used to determine distribution, median and interquartile range (Tukey's Hinges Percentile) were used to summarize variables. The differences between the Independent-Samples Mann Whitney U Test and the data of the patient groups and the optimal cut-off values, sensitivity and specificity values will be determined by ROC analysis. It will be considered statistically significant when the p value is below 0.05 (with the two-tailed test)
Detailed description
The aim of this study is to examine the effectiveness of routine laboratory complete blood count parameters and rates as diagnostic and prognostic criteria in severe COVID-19.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 Survivor groups | – | Diagnostic Test: HemogramCovid-19 survivor groups are hematological parameters |
| Covid-19 Non-survivor groups | – | Diagnostic Test: HemogramHematological parameters in patients with severe COVID-19 who have died. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study had 169 patients in all, including 44 women and 125 males
Key inclusion criteria (3 listed)
- Patients over the age of 18
- Critical patients taken to intensive care
- The length of stay in the ICU is more than 24 hours
Key exclusion criteria (1 listed)
- 1) Patients under 18 years of age (2) Patients with hematological malignancies (3) The length of stay in the ICU is less than 24 hours.
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 |
|---|---|---|
| HemogramSysmex XN-1000 hematological analyzer | Diagnostic test | Covid-19 Non-survivor groups, Covid-19 Survivor groups |
Primary outcome
Hematological parameters in the prognosis of severe Covid-19 patients.
Time frame: 2020-2021
Hemogram values of the deceased and surviving patients participating in the study were compared.
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 14 Dec 2022.
- Individual participant dataSharing planned: Yes. After accepted by Journal.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Ramazan Gozukucuk study chair
Istanbul Galata Universty
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 Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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 14 Dec 2022. 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 Turkey (Türkiye). 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?
Hematological parameters in the prognosis of severe Covid-19 patients. (time frame: 2020-2021). 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 14 Dec 2022.