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Markers of Severity (CD177,S100A8 &S100A12) in Sever Acute Respiratory Syndrome Coronavirus 2(SARS-COV-2) Patients

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
real time PCR
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COVID 19 hospitalized patients (diagnosed by RT-PCR)

Exclusion Criteria:

  • Age below 18 years and above 80.

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

control group

ICU COVID 19 patients

non-ICU covid 19 patients

Arm Description

Healthy control group

ICU COVID 19 patients

non-ICU covid 19 patients

Outcomes

Primary Outcome Measures

Markers of severity(CD177) in Sever respiratory syndrome coronavirus 2 (SARS-COV-2) patients
- Measuring gene expression for CD 177 by RT-PCR and also by ELISA. Measuring gene expression for CD 177 by RT-PCR and also by ELISA.
Markers of severity(S100A8&S100A12) in Sever respiratory syndrome coronavirus 2 (SARS-COV-2) patients
Measuring level of S100A8 and S100A12 by ELISA.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2022
Last Updated
January 20, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05201625
Brief Title
Markers of Severity (CD177,S100A8 &S100A12) in Sever Acute Respiratory Syndrome Coronavirus 2(SARS-COV-2) Patients
Official Title
Markers of Severity in Covid 19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients infected with covid-19 have a series of clinical manifestations, including fever, cough, myalgia or fatigue, dyspnea, even acute respiratory distress syndrome (ARDS), acute cardiac injury and secondary infection, and a lot of sever patients had to been admitted to the intensive care unit (ICU) One of the hallmark of COVID 19 is the cytokine storm that provokes primarily pneumonia followed by systemic inflammation. besides the positive viral nucleic acid analysis and the representative pulmonary CT findings (bilateral distribution of patchy shadows and ground glass opacity), most individual patients showed the changes in several immunological and biological markers . CD177 which is one of the most clinically important neutrophil alloantigen because: i) it is a neutrophil-specific marker representative of neutrophil activation, ii) it was the most highly differentiated expressed gene in patients, and iii) the protein can be measured in the serum, making its use as a marker clinically applicable. It is expressed on neutrophils, neutrophilic metamyelocytes, and myelocytes . Given the contribution of the neutrophil activation pathway in the clustering of COVID-19 patients, neutrophil-activation features that could act as possible reliable markers of disease evolution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Healthy control group
Arm Title
ICU COVID 19 patients
Arm Type
Active Comparator
Arm Description
ICU COVID 19 patients
Arm Title
non-ICU covid 19 patients
Arm Type
Active Comparator
Arm Description
non-ICU covid 19 patients
Intervention Type
Diagnostic Test
Intervention Name(s)
real time PCR
Intervention Description
real time PCR
Primary Outcome Measure Information:
Title
Markers of severity(CD177) in Sever respiratory syndrome coronavirus 2 (SARS-COV-2) patients
Description
- Measuring gene expression for CD 177 by RT-PCR and also by ELISA. Measuring gene expression for CD 177 by RT-PCR and also by ELISA.
Time Frame
one year
Title
Markers of severity(S100A8&S100A12) in Sever respiratory syndrome coronavirus 2 (SARS-COV-2) patients
Description
Measuring level of S100A8 and S100A12 by ELISA.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COVID 19 hospitalized patients (diagnosed by RT-PCR) Exclusion Criteria: Age below 18 years and above 80.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mai h hamed, assistant lecturer
Phone
01009560474
Email
maihamdy3535@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
abeer s mohamed, professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R ElSherif, professor

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31986264
Citation
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
Results Reference
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PubMed Identifier
31978945
Citation
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
Results Reference
background
PubMed Identifier
32717743
Citation
Lucas C, Wong P, Klein J, Castro TBR, Silva J, Sundaram M, Ellingson MK, Mao T, Oh JE, Israelow B, Takahashi T, Tokuyama M, Lu P, Venkataraman A, Park A, Mohanty S, Wang H, Wyllie AL, Vogels CBF, Earnest R, Lapidus S, Ott IM, Moore AJ, Muenker MC, Fournier JB, Campbell M, Odio CD, Casanovas-Massana A; Yale IMPACT Team; Herbst R, Shaw AC, Medzhitov R, Schulz WL, Grubaugh ND, Dela Cruz C, Farhadian S, Ko AI, Omer SB, Iwasaki A. Longitudinal analyses reveal immunological misfiring in severe COVID-19. Nature. 2020 Aug;584(7821):463-469. doi: 10.1038/s41586-020-2588-y. Epub 2020 Jul 27.
Results Reference
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PubMed Identifier
32359396
Citation
Ong EZ, Chan YFZ, Leong WY, Lee NMY, Kalimuddin S, Haja Mohideen SM, Chan KS, Tan AT, Bertoletti A, Ooi EE, Low JGH. A Dynamic Immune Response Shapes COVID-19 Progression. Cell Host Microbe. 2020 Jun 10;27(6):879-882.e2. doi: 10.1016/j.chom.2020.03.021. Epub 2020 Apr 30.
Results Reference
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Markers of Severity (CD177,S100A8 &S100A12) in Sever Acute Respiratory Syndrome Coronavirus 2(SARS-COV-2) Patients

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