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

• ClinicalTrials.gov Identifier: NCT04780555
• Recruitment Status: Completed
• First Posted: March 3, 2021
• Last Update Posted: August 3, 2021
• Sponsor: Abant Izzet Baysal University
• Information provided by (Responsible Party): Elif yaksi, Abant Izzet Baysal University

Study Description

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.

Condition or disease
Covid19

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Pain Symptoms Correlation With Biochemical and Radiological Findings in COVID-19
• Actual Study Start Date: March 1, 2021
• Actual Primary Completion Date: July 25, 2021
• Actual Study Completion Date: August 1, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Biospecimen Retention:   Samples Without DNA

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

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)

Contacts and Locations

Locations

Turkey

Elif Yakşi

Merkez, Bolu, Turkey, 14030

Sponsors and Collaborators

Abant Izzet Baysal University

Investigators

• Principal Investigator: 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

More Information

• Responsible Party: Elif yaksi, Medical Doctor, Abant Izzet Baysal University
• ClinicalTrials.gov Identifier: NCT04780555
• Other Study ID Numbers: AIBU-FTR-EY-02
• First Posted: March 3, 2021
• Last Update Posted: August 3, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elif yaksi, Abant Izzet Baysal University:

pain

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases