COVID-19NCT04507282
Eosinophil and Anticoagulation in COVID-19 Patients
An observational study of COVID-19, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
Trial summary
Despite prophylactic anticoagulant treatments, thrombotic complications may develop in patients with Coronavirus disease 2019 (COVID-19). This study aimed to evaluate anti-Factor Xa levels to determine the anticoagulant activity of low molecular weight heparin (LMWH) in COVID-19 patients. 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?
- LMWH
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2020to 15 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 18 years and older
- All sexes
- Adult, Older adult
Study population: COVID 19 positive patients treated with LMWH
Who may be able to join
- Patients older than 18 years, who were diagnosed with COVID-19 and were administered LMWH,
- agreed to participate in the study were included
Who cannot join
- Patients with previous coagulopathy,
- continuous indication of anticoagulant therapy (atrial fibrillation (AF), valve disease),
- glomerular filtration rate (GFR) <30 mL/min or undergoing dialysis, or with known liver dysfunction were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas Hastanesi
Yıldırım, 16310
About this study
Official title: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Despite prophylactic anticoagulant treatments, thrombotic complications may develop in patients with Coronavirus disease 2019 (COVID-19). This study aimed to evaluate anti-Factor Xa levels to determine the anticoagulant activity of low molecular weight heparin (LMWH) in COVID-19 patients.
- Conditions
- COVID-19
- Being tested
- LMWH
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMWHDrug
COVID 19 positive patients anticogulation level, subprophylactic level and prophylactic level
| Study group | Role | What they receive |
|---|---|---|
| COVID 19 positive patients | Not described Receives: Drug: LMWH |
What is being measured
The primary outcome is the main question the study is designed to answer.
subprophylactic anticogulation level
<0.2IU/ml
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start15 May 2020
- Primary completion1 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507282
- Sponsor's protocol ID
- Bursa Postgraduate Hospital
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ari S, Can V, Demir OF, Ari H, Agca FV, Melek M, Camci S, Dikis OS, Huysal K, Turk T. Elevated eosinophil count is related with lower anti-factor Xa activity in COVID-19 patients. J Hematop. 2020 Oct 8;13(4):249-258. doi: 10.1007/s12308-020-00419-3. eCollection 2020 Dec.
PubMed 33046998
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
- ClinicalTrials.gov ID
- NCT04507282
- Acronym / sponsor ID
- Bursa Postgraduate Hospital
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 11 Aug 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.
Despite prophylactic anticoagulant treatments, thrombotic complications may develop in patients with Coronavirus disease 2019 (COVID-19). This study aimed to evaluate anti-Factor Xa levels to determine the anticoagulant activity of low molecular weight heparin (LMWH) in COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID 19 positive patients | – | Drug: LMWH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID 19 positive patients treated with LMWH
Key inclusion criteria (2 listed)
- Patients older than 18 years, who were diagnosed with COVID-19 and were administered LMWH,
- agreed to participate in the study were included
Key exclusion criteria (3 listed)
- Patients with previous coagulopathy,
- continuous indication of anticoagulant therapy (atrial fibrillation (AF), valve disease),
- glomerular filtration rate (GFR) <30 mL/min or undergoing dialysis, or with known liver dysfunction were 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 |
|---|---|---|
| LMWHCOVID 19 positive patients anticogulation level, subprophylactic level and prophylactic level | Drug | COVID 19 positive patients |
Primary outcome
subprophylactic anticogulation level
Time frame: 14 days
<0.2IU/ml
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 18 Aug 2020.
- Derived from this study: PubMed 33046998Ari S, Can V, Demir OF, Ari H, Agca FV, Melek M, Camci S, Dikis OS, Huysal K, Turk T. Elevated eosinophil count is related with lower anti-factor Xa activity in COVID-19 patients. J Hematop. 2020 Oct 8;13(4):249-258. doi: 10.1007/s12308-020-00419-3. eCollection 2020 Dec.
- Individual participant dataSharing planned: No
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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, run by Bursa Postgraduate 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 2 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 18 Aug 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?
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?
subprophylactic anticogulation level (time frame: 14 days). 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 NCT04507282, which also lists 1 linked publication.
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 18 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.