Eosinophil and Anticoagulation in COVID-19 Patients | NCT04507282

Studies
Eosinophil and Anticoagulation in COVID-19 Patients

NCT04507282

Sponsor

Bursa Postgraduate Hospital

Status

Completed

Last Update Posted

Aug 18, 2020Actual

Enrollment

80Actual

Phase

Not provided

Conditions

COVID-19

Interventions

LMWH

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Jul 15, 2020Actual

First Submitted Date

Aug 7, 2020

First Submission Date that Met QC Criteria

Aug 7, 2020

First Posted Date

Aug 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2020

Last Update Posted Date

Aug 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID 19 positive patients			Drug: LMWH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LMWH	Drug	COVID 19 positive patients anticogulation level, subprophylactic level and prophylactic level	COVID 19 positive patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
subprophylactic anticogulation level	<0.2IU/ml	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 18 years, who were diagnosed with COVID-19 and were administered LMWH,
agreed to participate in the study were included

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

COVID 19 positive patients treated with LMWH

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bursa Yüksek İhtisas Hastanesi		Yıldırım		16310	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33046998	Derived	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.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates