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

NCT ID: NCT05201625

Last Updated: 2022-01-21

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

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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control group

Healthy control group

Group Type ACTIVE_COMPARATOR

real time PCR

Intervention Type DIAGNOSTIC_TEST

real time PCR

ICU COVID 19 patients

ICU COVID 19 patients

Group Type ACTIVE_COMPARATOR

real time PCR

Intervention Type DIAGNOSTIC_TEST

real time PCR

non-ICU covid 19 patients

non-ICU covid 19 patients

Group Type ACTIVE_COMPARATOR

real time PCR

Intervention Type DIAGNOSTIC_TEST

real time PCR

Interventions

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real time PCR

real time PCR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age below 18 years and above 80.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mai Hamdy Hamed

Assistant lecturer of microbiology and immunology in sohag general hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mai h hamed, assistant lecturer

Role: CONTACT

01009560474

abeer s mohamed, professor

Role: CONTACT

Facility Contacts

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Osama R ElSherif, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31986264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31978945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32717743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32359396 (View on PubMed)

Other Identifiers

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Soh-Med-21-11-22

Identifier Type: -

Identifier Source: org_study_id

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