NCT04470557

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Status
unknown

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

July 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

July 11, 2020

Last Update Submit

July 13, 2020

Conditions

COVID-19

Keywords

LaboratorySeverityCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Estimation of severity of patients with COVID-19 in relation to Laboratory findings.

    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

Study Arms (1)

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

Interventions

D-dimer,CBC.ESR,CRP,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.

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

Patients with COVID-19

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with known chronic chest disease preceding the infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 32065057BACKGROUND

  • 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.

    PMID: 26247033BACKGROUND

  • 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.

    PMID: 32573713RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Esam_eldeen M. Abdalla, Doctorate

    Assiut University

    STUDY CHAIR

  • Heba Abdellatif, Doctorate

    Assiut University

    STUDY CHAIR

Central Study Contacts

Anwar M. Ali, Doctorate

CONTACT

01030361010anwarmoha2006@yahoo.com

Ghydaa A. Shehata, Doctorate

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 11, 2020

First Posted

July 14, 2020

Study Start

July 15, 2020

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share