MMP-9, TIMP-9 in Lung Imaging and Functional of COVID-19

NCT05844215 | Completed DMC

• 1 other identifier: 206/RSUA
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the role of the extracellular matrix in lung abnormalities in COVID-19 patients. Anatomical abnormalities of the lungs can be observed by the presence of abnormalities on a chest x-ray that is scored using the Brixia index. The presence of COVID-19 pneumonia can impact oxygenation disorders. It is hoped that knowing the relationship between biomarkers that affect the extracellular matrix and anatomical and functional abnormalities can open up new insights into new therapeutic opportunities. The balance of MMP-9 and TIMP-1 has been studied in relation to several lung diseases other than COVID-19.

Conditions

Pulmonary Infection; COVID-19; Extracellular Matrix Alteration

Outcome Measures

Primary Outcomes (2)

• Anatomical abnormalities of the lungs.

  Anatomical of the lung measured by Chest X-ray abnormality, scored by Brixia Index.

  Chest X-Ray checked 2-4 hours during admission in emergency room.

• Functional abnormalities of the lungs.

  Functional of the lung measured by the oxygen used and Blood Gas Analysis.

  Oxygen use and blood gas analysis checked 1-2 hours during admission in emergency room.

Secondary Outcomes (2)

• Severity

  Severity measured when patient hospitalized at first time during inclusion of study (4-6 hours after admission).

• Mortality

  Mortality measured when patient out from hospital during the study (end of study).

Study Arms (2)

Non-Severe

Non-severe groups consisted of mild and moderate severity of COVID-19. Mild-degree are patients with symptoms of COVID-19 but do not require oxygen with normal X-ray images. Moderate-degree are patients with symptoms of COVID-19 that require a low oxygen flow rate with minimal pneumonia on chest X-Ray.

Diagnostic Test: MMP-9 and TIMP-1

Severe

Severe groups consisted of Severe and Critical Ill of COVID-19. Severe-degree are patients that require high oxygen flow rate with diffuse lung infiltrates. Critical-Ill are COVID-19 patients that suffered shock sepsis or respiratory failure.

Diagnostic Test: MMP-9 and TIMP-1

Interventions

MMP-9 and TIMP-1 DIAGNOSTIC_TEST

Examine level of serum MMP-9 and TIMP-1

Non-Severe; Severe

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult hospitalized COVID-19 patients in Universitas Airlangga Surabaya, Indonesia, proven by positive swab RT-PCR COVID-19.

You may qualify if:

• The patient is infected with COVID-19 with positive RT-PCR Swab results
• Age 21-70 years
• Men or Women
• Various degrees of severity (mild, moderate, severe, critical) and comorbidities
• the Chest X-ray was done
• Willing to participate in research (signing informed consent)

You may not qualify if:

• The patient is TB active or has been treated for pulmonary TB
• Patients with a history of ILD clinically
• Patients with a history of asthma or COPD
• Pregnant women
• HIV/AIDS patients

Sponsors & Collaborators

• Universitas Airlangga: lead

Study Sites (1)

Universitas Airlangga Hospital

Surabaya, East Java, 60115, Indonesia

Location

Related Publications (8)

• Lingeswaran M, Goyal T, Ghosh R, Suri S, Mitra P, Misra S, Sharma P. Inflammation, Immunity and Immunogenetics in COVID-19: A Narrative Review. Indian J Clin Biochem. 2020 Jul;35(3):260-273. doi: 10.1007/s12291-020-00897-3. Epub 2020 Jun 6.

  PMID: 32641873 BACKGROUND

• Ojo AS, Balogun SA, Williams OT, Ojo OS. Pulmonary Fibrosis in COVID-19 Survivors: Predictive Factors and Risk Reduction Strategies. Pulm Med. 2020 Aug 10;2020:6175964. doi: 10.1155/2020/6175964. eCollection 2020.

  PMID: 32850151 BACKGROUND

• Gill SE, Parks WC. Metalloproteinases and their inhibitors: regulators of wound healing. Int J Biochem Cell Biol. 2008;40(6-7):1334-47. doi: 10.1016/j.biocel.2007.10.024. Epub 2007 Oct 26.

  PMID: 18083622 BACKGROUND

• Signoroni A, Savardi M, Benini S, Adami N, Leonardi R, Gibellini P, Vaccher F, Ravanelli M, Borghesi A, Maroldi R, Farina D. BS-Net: Learning COVID-19 pneumonia severity on a large chest X-ray dataset. Med Image Anal. 2021 Jul;71:102046. doi: 10.1016/j.media.2021.102046. Epub 2021 Mar 31.

  PMID: 33862337 BACKGROUND

• Gu Y, Wang D, Chen C, Lu W, Liu H, Lv T, Song Y, Zhang F. PaO2/FiO2 and IL-6 are risk factors of mortality for intensive care COVID-19 patients. Sci Rep. 2021 Apr 1;11(1):7334. doi: 10.1038/s41598-021-86676-3.

  PMID: 33795768 BACKGROUND

• Elkington PT, Friedland JS. Matrix metalloproteinases in destructive pulmonary pathology. Thorax. 2006 Mar;61(3):259-66. doi: 10.1136/thx.2005.051979. Epub 2005 Oct 14.

  PMID: 16227332 BACKGROUND

• D Avila-Mesquita C, Couto AES, Campos LCB, Vasconcelos TF, Michelon-Barbosa J, Corsi CAC, Mestriner F, Petroski-Moraes BC, Garbellini-Diab MJ, Couto DMS, Jordani MC, Ferro D, Sbragia L, Joviliano EE, Evora PR, Carvalho Santana R, Martins-Filho OA, Polonis K, Menegueti MG, Ribeiro MS, Auxiliadora-Martins M, Becari C. MMP-2 and MMP-9 levels in plasma are altered and associated with mortality in COVID-19 patients. Biomed Pharmacother. 2021 Oct;142:112067. doi: 10.1016/j.biopha.2021.112067. Epub 2021 Aug 20.

  PMID: 34449310 BACKGROUND

• Guizani I, Fourti N, Zidi W, Feki M, Allal-Elasmi M. SARS-CoV-2 and pathological matrix remodeling mediators. Inflamm Res. 2021 Aug;70(8):847-858. doi: 10.1007/s00011-021-01487-6. Epub 2021 Jul 20.

  PMID: 34286362 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood sample was taken from the sample study during admission (after the patient agreed to join the study and signed the informed consent). Blood is stored in a refrigerator at -80 degrees Celsius. After all study samples have been collected, the blood is removed from the refrigerator and examined by ELISA. The distance between the first and last blood samples was about six months, and then a sample examination was carried out simultaneously. MMP-9 and TIMP-1 were checked using ELISA from sample blood.

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

Study Officials

• Muhammad Amin, Prof.

  Airlangga University Faculty of Medicine: Universitas Airlangga Fakultas Kedokteran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student, Faculty of Medicine

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 6, 2023
• Study Start: March 15, 2021
• Primary Completion: December 24, 2021
• Study Completion: July 20, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

ID (1)