COVID-19 Clinical Trial
Official title:
Role of MMP-9, TIMP-1 as Markers of Lung Imaging and Functional Abnormality of COVID-19
NCT number | NCT05844215 |
Other study ID # | 206/RSUA |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2021 |
Est. completion date | July 20, 2022 |
Verified date | May 2023 |
Source | Universitas Airlangga |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | July 20, 2022 |
Est. primary completion date | December 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Universitas Airlangga Hospital | Surabaya | East Java |
Lead Sponsor | Collaborator |
---|---|
Universitas Airlangga |
Indonesia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Severity | Severity is the degree of severity at the time of admission to the hospital. | Severity measured when patient hospitalized at first time during inclusion of study (4-6 hours after admission). | |
Secondary | Mortality | Mortality is measured by the condition of being discharged from the hospital, whether dead or alive. | Mortality measured when patient out from hospital during the study (end of study). |
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