Evaluation of Musculoskeletal System Symptoms and Biochem... | NCT04780555

Studies
Evaluation of Musculoskeletal System Symptoms and Biochemical Parameters in COVID-19

NCT04780555

Sponsor

Abant Izzet Baysal University

Status

Completed

Last Update Posted

Aug 3, 2021Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Covid19

Interventions

Not provided

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 2021

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

Mar 1, 2021Actual

Primary Completion Date

Jul 25, 2021Actual

Completion Date

Aug 1, 2021Actual

First Submitted Date

Feb 21, 2021

First Submission Date that Met QC Criteria

Mar 2, 2021

First Posted Date

Mar 3, 2021Actual

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 2, 2021

Last Update Posted Date

Aug 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elif yaksi, Medical Doctor, Abant Izzet Baysal UniversityPrincipal Investigator

Lead Sponsor

Abant Izzet Baysal UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The neutrophil-lymphocyte ratio (NLR) used to demonstrate inflammatory status in recent years can be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count at routine blood tests.

Detailed Description

Dysregulation in immune responses has been reported in association with hyperinflammation in COVID-19 patients, NLR has been linked to the severity of the patient's clinical status, and an increase in NLR is reported to be an independent risk factor for in-hospital mortality. Pain is a frequently seen symptom at the onset of viral infections and throughout the course of the disease. Although the pain mechanisms triggered by viral pathogens are not yet entirely understood, pain is thought to arise as a result of direct activation of nociceptor neurons by pathogens and their interaction with molecular ligands. Toll-like receptor 7 (TLR7), a pathogen recognition receptor that plays an important role in immune responses to viruses by binding to viral RNA, is known to be involved in pain development in different RNA virus infections. Park et al. showed that extracellular micro RNAs activate nociceptive neurons via the TLR7 pathway. Although these mechanisms have been demonstrated for different viral infections, the viral pathogenesis leading to pain in COVID-19 is still unclear. The purpose of this study was to investigate the prevalence of headache and muscular pain in patients diagnosed with COVID-19 and to determine the relationship between these symptoms and inflammatory parameters.

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

Retention

Enrollment

150Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neutrophil-lymphocyte ratio (NLR)	It can be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count at routine blood tests	Baseline
D-dimer	Peripheral venous blood specimens were collected using standard surgical procedures	Baseline
Fibrinogen	Peripheral venous blood specimens were collected using standard surgical procedures	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18-70
Diagnosed with COVID-19

Exclusion Criteria:

Patients with suspected SARS-CoV-2 infection, with two negative RT-PCR tests, hospitalized in the intensive care unit during inclusion in the study
Musculoskeletal pains in the previous three months, with diseases capable of causing myalgia prior to diagnosis (such as fibromyalgia and inflammatory muscle disease)
Cognitive disorders capable of preventing history-taking and physical examination such as mental disability and dementia,
previous history of headache (migraine, tension type headache)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients aged 18-65 and diagnosed with COVID-19 will be included in the study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nalan Doğan, MD	Beykoz State Hospital	Principal Investigator
Dursun Karakaş, MD	Sancaktepe Şehit İlhan Varank Research Hospital	Principal Investigator
Osman Yakşi, MD	Abant İzzet Baysal University Medical Faculty	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elif Yakşi		Merkez	Bolu	14030	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D010146	Pain

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Peripheral venous blood specimens will be collected using standard surgical procedures during presentation and were investigated in the Abant İzzet Baysal University Medical Faculty central laboratory. Complete blood count parameters (hemoglobin, leukocytes, erythrocytes, platelets, and leukocyte subtypes) will be analyzed using a Syxmex XN-1000 (Kobe, Japan) automatic analyzer. D-dimer and fibrinogen parameters will be measured on a Sysmex CS-2500 (Kobe, Japan) device, and biochemical parameters (CRP, ferritin, procalcitonin, LDH, troponin) on an automatic biochemical analyzer (Abbott Architect C8000, USA). In addition, the NLR will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count.