- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780555
Evaluation of Musculoskeletal System Symptoms and Biochemical Parameters in COVID-19
August 2, 2021 updated by: Elif yaksi, Abant Izzet Baysal University
Evaluation of Pain Symptoms Correlation With Biochemical and Radiological Findings in COVID-19
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bolu
-
Merkez, Bolu, Turkey, 14030
- Elif Yakşi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients aged 18-65 and diagnosed with COVID-19 will be included in the study.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
D-dimer
Time Frame: Baseline
|
Peripheral venous blood specimens were collected using standard surgical procedures
|
Baseline
|
Fibrinogen
Time Frame: Baseline
|
Peripheral venous blood specimens were collected using standard surgical procedures
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
July 25, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
February 21, 2021
First Submitted That Met QC Criteria
March 2, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
August 3, 2021
Last Update Submitted That Met QC Criteria
August 2, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-EY-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted