Clinical trial NCT04780555: Evaluation of Musculoskeletal System Symptoms and Biochemical Parameters in COVID-19
Official title: Evaluation of Pain Symptoms Correlation With Biochemical and Radiological Findings in COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: pain
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-65 and diagnosed with COVID-19 will be included in the study.

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.

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)

Primary outcomes:
measure: Neutrophil-lymphocyte ratio (NLR)
timeFrame: Baseline
measure: D-dimer
timeFrame: Baseline
measure: Fibrinogen
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Elif Yakşi
state: Bolu
Study officials:
affiliation: Beykoz State Hospital
name: Nalan Doğan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sancaktepe Şehit İlhan Varank Research Hospital
name: Dursun Karakaş, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abant İzzet Baysal University Medical Faculty
name: Osman Yakşi, MD
role: PRINCIPAL_INVESTIGATOR
References: