NCT04780555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

February 21, 2021

Last Update Submit

August 2, 2021

Conditions

Keywords

pain

Outcome Measures

Primary Outcomes (3)

  • Neutrophil-lymphocyte ratio (NLR)

    It can be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count at routine blood tests

    Baseline

  • D-dimer

    Peripheral venous blood specimens were collected using standard surgical procedures

    Baseline

  • Fibrinogen

    Peripheral venous blood specimens were collected using standard surgical procedures

    Baseline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Aged 18-70
  • Diagnosed with COVID-19

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elif Yakşi

Merkez, Bolu, 14030, Turkey (Türkiye)

Location

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.

MeSH Terms

Conditions

COVID-19Pain

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 21, 2021

First Posted

March 3, 2021

Study Start

March 1, 2021

Primary Completion

July 25, 2021

Study Completion

August 1, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations