Relation Between Lab Finding and COVID-19 Severity

July 13, 2020 updated by: Anwar Mohamed Ali, Assiut University

The Relationship Between Lab Finding and COVID-19 Severity: Multicenter Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

. 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ghydaa A. Shehata, Doctorate

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will be conducted on 100 patients with COVID-19 patients of all age groups and both sexes.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: 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.
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),

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of severity of patients with COVID-19 in relation to Laboratory findings.
Time Frame: up to 1 month
with successful completion of the aim, the investigators will establish the correlation between laboratory findings and severity of COVID-19 patients according to WHO classification.
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Esam_eldeen M. Abdalla, Doctorate, Assiut University
  • Study Chair: Heba Abdellatif, Doctorate, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

July 15, 2020

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

July 11, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (ACTUAL)

July 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLCS

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.

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