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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04780555
Other study ID # AIBU-FTR-EY-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date August 1, 2021

Study information

Verified date August 2021
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date August 1, 2021
Est. primary completion date July 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Elif Yaksi Merkez Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

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