Covid-19NCT04378829
Platelet Count, Platelet, Mean Platelet Volume and Platelet Distribution Width in COVID-19
An observational study of Covid-19 and Mean Platelet Volume, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study will aim to investigate the relation of platelet count (PLT), mean platelet volume (MPV) and platelet distribution width (PDW) with other acute phase reactant c-reactive protein(CRP) in Coronavirus(COVID-19). As a methodology, patients will be selected in records in one month from the online hospital system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid-19, Mean Platelet Volume, Platelet Destruction
- What is being tested?
- Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Sep 2020to 21 Oct 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: The study group will be selected from patients followed up in the 1-month period from the hospital online COVID-19 monitoring system.
Who may be able to join
- Patients diagnosed with COVID-19, both PCR tests and computed tomography, as well as control hemogram and CRP tests at one week intervals will be included.
Who cannot join
- Those with suspicion of COVID-19, those who do not perform hemogram and c-reactive protein tests 3 times with one week intervals, those who do not have standard drug treatment will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Platelet Count, Mean Platelet Volume and Platelet Distribution Width Change in COVID-19 Pandemic, ?
The study will aim to investigate the relation of platelet count (PLT), mean platelet volume (MPV) and platelet distribution width (PDW) with other acute phase reactant c-reactive protein(CRP) in Coronavirus(COVID-19).
As a methodology, patients will be selected in records in one month from the online hospital system. Two groups will be divided before as need for mechanical ventilation or not. The latter comparison will be about three groups as an ambulatory follow-up, hospital follow-up, and intensive care unit follow-up. Parameters will be analyzed according to the groups.
Read the detailed description
In this study, as a methodology, patients diagnosed with PCR test through the online system created for COVID-19 patients will be included in the study. These patients will be divided into 3 groups as outpatient follow-up, hospital follow-up and follow-up with a mechanical ventilator in intensive care. In addition, patients who have completed the 14-day treatment period, which is considered as the turning point time of the world health organization by looking at the patients 3 times, every 5-7 days, which is the accepted incubation period, will be included in the study. In these patients, hemoglobin, leukocyte, platelet, MPV, PDW and CRP values will be examined for 3 weekly measurements. Changes in COVID-19 disease follow-up and treatment of MPV and PDW values, which have not been studied so far, will be investigated.
- Conditions
- Covid-19, Mean Platelet Volume, Platelet Destruction
- Being tested
- Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19Diagnostic test
Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19
| Study group | Role | What they receive |
|---|---|---|
| ambulatory follow-up | Not described Receives: Diagnostic Test: Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 | |
| hospital follow-up | Not described Receives: Diagnostic Test: Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 | |
| intensive care unit follow-up | Not described Receives: Diagnostic Test: Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PDW and MPV parameters
Expected increase or decrease in parameters according to the course of the disease
Measured: 3 weeks totally tests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start12 Sep 2020
- Primary completion11 Oct 2020
- Study completion21 Oct 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.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Tire, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378829
- Sponsor's protocol ID
- COVID-19
- Status last verified
- Sep 2021
- First submitted
- 3 May 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Platelet Count, Mean Platelet Volume and Platelet Distribution Width Change in COVID-19 Pandemic, ?
- ClinicalTrials.gov ID
- NCT04378829
- Acronym / sponsor ID
- COVID-19
- Conditions
- Covid-19, Mean Platelet Volume, Platelet Destruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 11 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 7 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.
The study will aim to investigate the relation of platelet count (PLT), mean platelet volume (MPV) and platelet distribution width (PDW) with other acute phase reactant c-reactive protein(CRP) in Coronavirus(COVID-19).
As a methodology, patients will be selected in records in one month from the online hospital system. Two groups will be divided before as need for mechanical ventilation or not. The latter comparison will be about three groups as an ambulatory follow-up, hospital follow-up, and intensive care unit follow-up. Parameters will be analyzed according to the groups.
Detailed description
In this study, as a methodology, patients diagnosed with PCR test through the online system created for COVID-19 patients will be included in the study. These patients will be divided into 3 groups as outpatient follow-up, hospital follow-up and follow-up with a mechanical ventilator in intensive care. In addition, patients who have completed the 14-day treatment period, which is considered as the turning point time of the world health organization by looking at the patients 3 times, every 5-7 days, which is the accepted incubation period, will be included in the study. In these patients, hemoglobin, leukocyte, platelet, MPV, PDW and CRP values will be examined for 3 weekly measurements. Changes in COVID-19 disease follow-up and treatment of MPV and PDW values, which have not been studied so far, will be investigated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ambulatory follow-up | – | Diagnostic Test: Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 |
| hospital follow-up | – | Diagnostic Test: Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 |
| intensive care unit follow-up | – | Diagnostic Test: Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study group will be selected from patients followed up in the 1-month period from the hospital online COVID-19 monitoring system.
Key inclusion criteria (1 listed)
- Patients diagnosed with COVID-19, both PCR tests and computed tomography, as well as control hemogram and CRP tests at one week intervals will be included.
Key exclusion criteria (1 listed)
- Those with suspicion of COVID-19, those who do not perform hemogram and c-reactive protein tests 3 times with one week intervals, those who do not have standard drug treatment will be excluded from the study.
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 |
|---|---|---|
| Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 | Diagnostic test | ambulatory follow-up, hospital follow-up, intensive care unit follow-up |
Primary outcome
Change in PDW and MPV parameters
Time frame: 3 weeks totally tests.
Expected increase or decrease in parameters according to the course of the disease
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 23 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Mean Platelet Volume, run by Konya Meram State 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 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 23 Sep 2021. 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?
Change in PDW and MPV parameters (time frame: 3 weeks totally tests.). 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 23 Sep 2021.