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

NCT05201625 | Unknown

• 1 other identifier: Soh-Med-21-11-22
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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.

  one year

• Markers of severity(S100A8&S100A12) in Sever respiratory syndrome coronavirus 2 (SARS-COV-2) patients

  Measuring level of S100A8 and S100A12 by ELISA.

  one year

Study Arms (3)

control group

ACTIVE COMPARATOR

Healthy control group

Diagnostic Test: real time PCR

ICU COVID 19 patients

ACTIVE COMPARATOR

ICU COVID 19 patients

Diagnostic Test: real time PCR

non-ICU covid 19 patients

ACTIVE COMPARATOR

non-ICU covid 19 patients

Diagnostic Test: real time PCR

Interventions

real time PCR DIAGNOSTIC_TEST

real time PCR

ICU COVID 19 patients; control group; non-ICU covid 19 patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age below 18 years and above 80.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 31986264 BACKGROUND

• 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.

  PMID: 31978945 BACKGROUND

• 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.

  PMID: 32717743 BACKGROUND

• 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.

  PMID: 32359396 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

mai h hamed, assistant lecturer

CONTACT

01009560474; maihamdy3535@gmail.com

abeer s mohamed, professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of microbiology and immunology in sohag general hospital

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 21, 2022
• Study Start: December 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)