Clinical trial NCT05201625: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Age below 18 years and above 80.

Primary outcomes:
measure: Markers of severity(CD177) in Sever respiratory syndrome coronavirus 2 (SARS-COV-2) patients
timeFrame: one year
measure: Markers of severity(S100A8&S100A12) in Sever respiratory syndrome coronavirus 2 (SARS-COV-2) patients
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
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.
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.
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.
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.