Coronavirus InfectionNCT04408378
Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients
An observational study of Coronavirus Infection, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Morbidity, mortality and progress depends on systemic inflammation especially in ARDS patients. Previous studies claims that the proportion of mean platellet volume to platellet which can simply be determined with simple blood tests that are performed at admission, might predict the mortality in ARDS patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- observation of covid 19 pneumonia
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2020to 20 Aug 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old who hospitalized with diagnosis of Covid-19 pneumonia between march and may 2020 in the ICU or ward.
Who may be able to join
- Patients over 18 years old who hospitalized with diagnosis of Covid-19 pneumonia between march and may 2020
Who cannot join
- Under 18 years old patients
- Patients with heamolytic diaseses
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa TREH
Istanbul, Gaziosmanpaşa, 34255
aygen türkmen, MD.prof., +902129453000 ext. 1436, aygenturkmen@hotmail.com
zuhal çavuş, MD
About this study
Official title: Retrospective Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients
Morbidity, mortality and progress depends on systemic inflammation especially in ARDS patients. Previous studies claims that the proportion of mean platellet volume to platellet which can simply be determined with simple blood tests that are performed at admission, might predict the mortality in ARDS patients. Covid-19 pneumonia has a very similar clinical outlook with ARDS. Therefore we decided to research whether that proportion is legitimate for detecting the progress of Covid-19 pneumonia or not.
Read the detailed description
Covid-19 pneumonia is a spesific disease dispate its similarity to ARDS. There are nomorous of studies that MPV/PLT ratio can predict the mortality, morbidity and the progress of ARDS. Depending on the similarity of ARDS, MPV/PLT ratio might predict the clinical progress of Covid-19 pneumonia. We retrospectively recruited150 patients admitted to our institute -a tertiary center- with Covid-19 pneumonia to our study. Clinical based defining research, by March-May 2020, the patients over 18 years old who were in either intensive care or ward scanned retrospectively. The laboratory tests, chronic diseases , age and gender has been collected from the written resources and electronic data retrospectively.
the patients who are diagnosed with Covid*19 pneumonia will be divided into two groups. The ones in the ward will be considered as mild clinical course, and the ones in the intensive care unit will be considered as severe clinical course. there will be an additional non Covid individuals as a control group, which will consist 52 patients each. The ratio of MPV to PLT will be calculated using admission hemogrames of these groups, and the significance of the statistical differences on determining the prognosis of the disease will be discussed.
Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., \& Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for istatistical power analysis.It was done using ANOVA test between at least two independent groups. In order to provide enoughsample magnitude power, which is 0.8, it was calculated that each group should have 52 patients which makes at total of 156.
The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be used in normal distrubitions, non-parametric ones will be uused in abnormal distrubitions. Between the independent groups, MPV/PLT ratio will be calculated using ANOVA test. Categoric data will be compared by Pearson ki square test and the p values less than 0.05 will be considered as significant.
we aim to have an opinion about Covid 19-pneomonia prognosis at the admission of hospital.
- Conditions
- Coronavirus Infection
- Being tested
- observation of covid 19 pneumonia
- Keywords
- covid-19, MPV/PLT, pneumonia
- Medical subject headings
- Coronavirus Infections, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of covid 19 pneumoniaOther
We try to reveal the fact,covid-19 pneumonia prognosis can be estimated by using MPV/PLT ratio
| Study group | Role | What they receive |
|---|---|---|
| mild pneumonia | The patients who has followed in the ward Receives: Other: observation of covid 19 pneumonia | |
| severe pneumonia | The patiens who has followed in the intensive care unit Receives: Other: observation of covid 19 pneumonia | |
| control group | patients who has not covid 19 pneumonia Receives: Other: observation of covid 19 pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimation of inflammatory changes in Covid 19 pneumonia by using MVP/PLT ratio
İt has been studied that MPV/PLT ratio can show the cl inical couses of several diseases as well as ARDS. we thought that we can identify the coronavirus pneumonia patients earlier, at admission of hospital by using the hemogrames.
Measured: March-May 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start5 Jun 2020 (estimated)
- Primary completion20 Jul 2020 (estimated)
- Study completion20 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies 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
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408378
- Sponsor's protocol ID
- 69
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim CH, Kim SJ, Lee MJ, Kwon YE, Kim YL, Park KS, Ryu HJ, Park JT, Han SH, Yoo TH, Kang SW, Oh HJ. An increase in mean platelet volume from baseline is associated with mortality in patients with severe sepsis or septic shock. PLoS One. 2015 Mar 5;10(3):e0119437. doi: 10.1371/journal.pone.0119437. eCollection 2015.
PubMed 25742300Fei Y, Zhang H, Zhang C. The application of lymphocyte*platelet and mean platelet volume/platelet ratio in influenza A infection in children. J Clin Lab Anal. 2019 Nov;33(9):e22995. doi: 10.1002/jcla.22995. Epub 2019 Aug 16.
PubMed 31420904Korniluk A, Koper-Lenkiewicz OM, Kaminska J, Kemona H, Dymicka-Piekarska V. Mean Platelet Volume (MPV): New Perspectives for an Old Marker in the Course and Prognosis of Inflammatory Conditions. Mediators Inflamm. 2019 Apr 17;2019:9213074. doi: 10.1155/2019/9213074. eCollection 2019.
PubMed 31148950
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients
- ClinicalTrials.gov ID
- NCT04408378
- Acronym / sponsor ID
- 69
- Conditions
- Coronavirus Infection
- Keywords
- covid-19, MPV/PLT, pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 5 Jun 2020 (estimated)
- Primary completion
- 20 Jul 2020 (estimated)
- Study completion
- 20 Aug 2020 (estimated)
- First posted
- 29 May 2020 (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.
Morbidity, mortality and progress depends on systemic inflammation especially in ARDS patients. Previous studies claims that the proportion of mean platellet volume to platellet which can simply be determined with simple blood tests that are performed at admission, might predict the mortality in ARDS patients. Covid-19 pneumonia has a very similar clinical outlook with ARDS. Therefore we decided to research whether that proportion is legitimate for detecting the progress of Covid-19 pneumonia or not.
Detailed description
Covid-19 pneumonia is a spesific disease dispate its similarity to ARDS. There are nomorous of studies that MPV/PLT ratio can predict the mortality, morbidity and the progress of ARDS. Depending on the similarity of ARDS, MPV/PLT ratio might predict the clinical progress of Covid-19 pneumonia. We retrospectively recruited150 patients admitted to our institute -a tertiary center- with Covid-19 pneumonia to our study. Clinical based defining research, by March-May 2020, the patients over 18 years old who were in either intensive care or ward scanned retrospectively. The laboratory tests, chronic diseases , age and gender has been collected from the written resources and electronic data retrospectively.
the patients who are diagnosed with Covid*19 pneumonia will be divided into two groups. The ones in the ward will be considered as mild clinical course, and the ones in the intensive care unit will be considered as severe clinical course. there will be an additional non Covid individuals as a control group, which will consist 52 patients each. The ratio of MPV to PLT will be calculated using admission hemogrames of these groups, and the significance of the statistical differences on determining the prognosis of the disease will be discussed.
Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., \& Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for istatistical power analysis.It was done using ANOVA test between at least two independent groups. In order to provide enoughsample magnitude power, which is 0.8, it was calculated that each group should have 52 patients which makes at total of 156.
The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be used in normal distrubitions, non-parametric ones will be uused in abnormal distrubitions. Between the independent groups, MPV/PLT ratio will be calculated using ANOVA test. Categoric data will be compared by Pearson ki square test and the p values less than 0.05 will be considered as significant.
we aim to have an opinion about Covid 19-pneomonia prognosis at the admission of hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild pneumonia | – | Other: observation of covid 19 pneumoniaThe patients who has followed in the ward |
| severe pneumonia | – | Other: observation of covid 19 pneumoniaThe patiens who has followed in the intensive care unit |
| control group | – | Other: observation of covid 19 pneumoniapatients who has not covid 19 pneumonia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old who hospitalized with diagnosis of Covid-19 pneumonia between march and may 2020 in the ICU or ward.
Key inclusion criteria (1 listed)
- Patients over 18 years old who hospitalized with diagnosis of Covid-19 pneumonia between march and may 2020
Key exclusion criteria (2 listed)
- Under 18 years old patients
- Patients with heamolytic diaseses
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 |
|---|---|---|
| observation of covid 19 pneumoniaWe try to reveal the fact,covid-19 pneumonia prognosis can be estimated by using MPV/PLT ratio | Other | control group, mild pneumonia, severe pneumonia |
Primary outcome
estimation of inflammatory changes in Covid 19 pneumonia by using MVP/PLT ratio
Time frame: March-May 2020
İt has been studied that MPV/PLT ratio can show the cl inical couses of several diseases as well as ARDS. we thought that we can identify the coronavirus pneumonia patients earlier, at admission of hospital by using the hemogrames.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Background: PubMed 25742300Kim CH, Kim SJ, Lee MJ, Kwon YE, Kim YL, Park KS, Ryu HJ, Park JT, Han SH, Yoo TH, Kang SW, Oh HJ. An increase in mean platelet volume from baseline is associated with mortality in patients with severe sepsis or septic shock. PLoS One. 2015 Mar 5;10(3):e0119437. doi: 10.1371/journal.pone.0119437. eCollection 2015.
- Background: PubMed 31420904Fei Y, Zhang H, Zhang C. The application of lymphocyte*platelet and mean platelet volume/platelet ratio in influenza A infection in children. J Clin Lab Anal. 2019 Nov;33(9):e22995. doi: 10.1002/jcla.22995. Epub 2019 Aug 16.
- Background: PubMed 31148950Korniluk A, Koper-Lenkiewicz OM, Kaminska J, Kemona H, Dymicka-Piekarska V. Mean Platelet Volume (MPV): New Perspectives for an Old Marker in the Course and Prognosis of Inflammatory Conditions. Mediators Inflamm. 2019 Apr 17;2019:9213074. doi: 10.1155/2019/9213074. eCollection 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Coronavirus Infection
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
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
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
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 Coronavirus Infection, run by Gaziosmanpasa Research and Education 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimation of inflammatory changes in Covid 19 pneumonia by using MVP/PLT ratio (time frame: March-May 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408378, which also lists 3 linked publications.
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 29 May 2020.