Relation Between Lab Finding and COVID-19 Severity

NCT ID: NCT04470557

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2020-12-01

Brief Summary

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Severe acute respiratory syndrome coronavirus 2 (COVID-19) poses substantial challenges for health care systems. With a vastly expanding amount of publications on COVID-19, clinicians need evidence synthesis to produce guidance for handling patients with COVID-19.

Detailed Description

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. Conavirus belongs to the subfamily of Ortho-coronavirinae in the family of Coronaviridae and the Order Nidovirales. In 2003, a SARS-CoV had caused the out- break of severe acute respiratory syndrome. In December 2019, an "unknown viral pneumonia" out- break has been reported. Finally, a novel coronavirus was detected, isolated virus was termed as SARS-CoV2, characterized as highly contagious and deadly. By the end of February 2020, more than 78,631 cases infected with SARS-CoV-2, and more than 2747 deaths were confrmed in China, and the COVID-19 has been declared a pan- demic by World Health Organization. For those infected by SARS-CoV-2, some of the patients didnot show hypoxemia or respiratory stress during the course of COVID-19, indicating a multifaceted disease of SARS-CoV-2 infection. Therefore, one reliable and convenient biomarker is needed to predict the severity of COVID-19 pneumonia. Recently, several studies have reported that C-reactive protein (CRP) is positively asso-ciated with severe dengue infection, and patients with higher plasma CRP in the initial period of dengue, are at higher risk to develop plasma leakage. We examined which routine laboratory tests are associated with severe COVID-19 disease, and the relation between the laboratory results and the security of COVID19 diasease, in two of large Upper Egypt medical centers, which are Aswan University and assiut university hospitals.

Conditions

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COVID-19

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with COVID-19

The patients will be subjected to to laboratory analyses, a number of hematological, immunological and biochemical parameters like total leucocytic count and differential count of CBC, ESR, D- dimer levels in plasma, CRP, serum urea and creatinine levels, serum levels of AST, ALT liver enzymes, serum ferritin levels Also, CT scan of chest, clinical assessment and the severity and course of the disease.

D-dimer,CBC.ESR,CRP,

Intervention Type DIAGNOSTIC_TEST

Complete blood count (for patients and control subjects): was done on CELL-DYN 3700 (Abbott-Germany) and blood film was stained by leishman staining, the morphology of red blood cells. CRP titre estimation by latix method .ESR erythrocyte sedimentation rate estimation (1:5) by Westerngreen tube method.

Liver function tests ,serum ferritin and PCR for COVID-19 .

Intervention Type DIAGNOSTIC_TEST

Serum ferritin was performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, Germany),

• Liver function tests ( aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase) and kidney funcrion were performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, G ermany),

Interventions

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D-dimer,CBC.ESR,CRP,

Complete blood count (for patients and control subjects): was done on CELL-DYN 3700 (Abbott-Germany) and blood film was stained by leishman staining, the morphology of red blood cells. CRP titre estimation by latix method .ESR erythrocyte sedimentation rate estimation (1:5) by Westerngreen tube method.

Intervention Type DIAGNOSTIC_TEST

Liver function tests ,serum ferritin and PCR for COVID-19 .

Serum ferritin was performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, Germany),

• Liver function tests ( aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase) and kidney funcrion were performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, G ermany),

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age: all ages.
* Sex: Males and females.
* COVID-19 patients approved by positive PCR.

Exclusion Criteria

* Patients with known chronic chest disease preceding the infection.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Anwar Mohamed Ali

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esam_eldeen M. Abdalla, Doctorate

Role: STUDY_CHAIR

Assiut University

Heba Abdellatif, Doctorate

Role: STUDY_CHAIR

Assiut University

Central Contacts

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Anwar M. Ali, Doctorate

Role: CONTACT

01030361010

Ghydaa A. Shehata, Doctorate

Role: CONTACT

References

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Zhang W, Du RH, Li B, Zheng XS, Yang XL, Hu B, Wang YY, Xiao GF, Yan B, Shi ZL, Zhou P. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071. eCollection 2020.

Reference Type BACKGROUND
PMID: 32065057 (View on PubMed)

Chen CC, Lee IK, Liu JW, Huang SY, Wang L. Utility of C-Reactive Protein Levels for Early Prediction of Dengue Severity in Adults. Biomed Res Int. 2015;2015:936062. doi: 10.1155/2015/936062. Epub 2015 Jul 12.

Reference Type BACKGROUND
PMID: 26247033 (View on PubMed)

Alnor A, Sandberg MB, Gils C, Vinholt PJ. Laboratory Tests and Outcome for Patients with Coronavirus Disease 2019: A Systematic Review and Meta-Analysis. J Appl Lab Med. 2020 Sep 1;5(5):1038-1049. doi: 10.1093/jalm/jfaa098.

Reference Type RESULT
PMID: 32573713 (View on PubMed)

Other Identifiers

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RLCS

Identifier Type: -

Identifier Source: org_study_id

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