Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04780555
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Elif yaksi, Abant Izzet Baysal University

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.

Layout table for study information
Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 1, 2021



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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780555


Contacts
Layout table for location contacts
Contact: Elif Yakşi, MD +905069078505 elifyaksi@hotmail.com

Locations
Layout table for location information
Turkey
Elif Yakşi Recruiting
Merkez, Bolu, Turkey, 14030
Contact: Elif Yakşi, M.D    05069078505      
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
Layout table for investigator information
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
Layout table for additonal 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    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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