Pulmonary InfectionNCT05844215
MMP-9, TIMP-9 in Lung Imaging and Functional of COVID-19
An observational study of Pulmonary Infection and COVID-19, run by Universitas Airlangga at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Pulmonary Infection, COVID-19, Extracellular Matrix Alteration
- What is being tested?
- MMP-9 and TIMP-1
- How many people
- 78 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Mar 2021to 20 Jul 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult hospitalized COVID-19 patients in Universitas Airlangga Surabaya, Indonesia, proven by positive swab RT-PCR COVID-19.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of MMP-9, TIMP-1 as Markers of Lung Imaging and Functional Abnormality of COVID-19
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.
Read the detailed description
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV2), which has different degrees of severity, is the cause of Coronavirus Disease 2019 (COVID-19). Over 97% of COVID-19 patients make a full recovery. Inflammation increases when COVID-19 severity increases. The lungs and endothelium will suffer harm when different pro-inflammatory cytokines are released. A cytokine storm is started when many immune cells produce cytokines and chemokines. The pro-inflammatory cytokine can increase angiogenesis, vascular permeability, keratin proliferation, and collagen production. Lung lesions are affected by certain disorders. In COVID-19 patients, angiogenesis, fibroblast activation, and collagen deposition all contribute to the repair of the lungs. The pathological outcome of acute or chronic interstitial pulmonary disease is lung fibrosis, characterized by abnormal collagen and extracellular matrix (ECM) deposition, the persistence of fibroblasts, failure of alveolar re-epithelization, and destruction of normal pulmonary architecture. The breakdown or buildup of ECM is influenced by the ratio of matrix metalloproteinase (MMP) and tissue inhibitor matrix metalloproteinase (TIMP). TIMP distribution, not MMP distribution, was the primary contributor to lung fibrosis. MMP expression is increased by the production of several hormones, cytokines (IL-1, IL-6), growth factors (TGF, TNF-), platelet-derived growth factor (PDGF), and basic fibroblast growth factor (bFGF).
ECM assistance is required for the alveoli to function normally. Excessive ECM breakdown and aberrant ECM remodelling are the root causes of many respiratory conditions, including pulmonary fibrosis. ECM buildup destroys the alveolar process, particularly by impairing alveolar-capillary diffusion. On radiological images, lung abnormalities can be seen as pneumonia in the bilateral ground-glass opacity basal, which results in hypoxia. In the lower portion, bilateral abnormalities predominated. COVID-19 ARDS, hypoxemia, bilateral infiltrates, and reduced lung compliance were the hallmarks of pneumonia type H. Despite the limited sensitivity, plain chest X-rays can detect lung abnormalities in COVID-19; they are inexpensive and simple. New infiltrates on chest radiographs were used to make the diagnosis of pneumonia.
Biomarkers of pulmonary interstitial abnormalities have received limited attention in the literature, including investigations on MMP and TIMP for lung abnormalities in COVID-19 patients. One of the MMP gelatinase family's more complicated forms, MMP-9, can break down ECM components. MMP-9 increases collagen and cytokine production, fibroblast migration, and TGF- stimulation. MMP-9 is among the MMPs that TIMP1 effectively inhibits. TIMP-1 binds to pro- or latent MMP-9. For ECM proteolysis to occur, MMP and TIMP must coexist in equilibrium. This study aimed to ascertain how MMP-9 and TIMP-1 affected abnormal chest X-rays, poor oxygenation, severity, and death.
Blood is taken from hospitalized COVID-19 patients to measure the serum concentrations of MMP-9 and TIMP-1. At the time of hospital admission, three reviewers assessed the severity after chest X-Rays, followed by a BRIXIA score. At the time of hospital discharge, patients were evaluated. The levels of MMP-9 and TIMP-1 were compared to Brixia scores, oxygen consumption, severity, and death.
- Being tested
- MMP-9 and TIMP-1
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMP-9 and TIMP-1Diagnostic test
Examine level of serum MMP-9 and TIMP-1
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: MMP-9 and TIMP-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical abnormalities of the lungs.
Anatomical of the lung measured by Chest X-ray abnormality, scored by Brixia Index.
Measured: 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.
Measured: Oxygen use and blood gas analysis checked 1-2 hours during admission in emergency room.
Secondary outcomes (2)
Severity
Severity is the degree of severity at the time of admission to the hospital.
Measured: Severity measured when patient hospitalized at first time during inclusion of study (4-6 hours after admission).
Mortality
Mortality is measured by the condition of being discharged from the hospital, whether dead or alive.
Measured: Mortality measured when patient out from hospital during the study (end of study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Mar 2021
- Primary completion24 Dec 2021
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pulmonary InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfian Nur Rosyid, Universitas Airlangga
- Investigators
- Muhammad Amin, Prof., Principal investigator, Airlangga University Faculty of Medicine: Universitas Airlangga Fakultas Kedokteran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844215
- Sponsor's protocol ID
- 206/RSUA
- Status last verified
- May 2023
- First submitted
- 29 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers have not yet decided to share data, but they do not rule out other researchers wishing to be able to access primary research data. Other researchers can contact the principal investigator via email.
Publications
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.
PubMed 32641873Ojo 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.
PubMed 32850151Gill 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.
PubMed 18083622Signoroni 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.
PubMed 33862337Gu 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.
PubMed 33795768Elkington 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.
PubMed 16227332D 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.
PubMed 34449310Guizani 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.
PubMed 34286362
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MMP-9, TIMP-1 as Markers of Lung Imaging and Functional Abnormality of COVID-19
- ClinicalTrials.gov ID
- NCT05844215
- Acronym / sponsor ID
- 206/RSUA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV2), which has different degrees of severity, is the cause of Coronavirus Disease 2019 (COVID-19). Over 97% of COVID-19 patients make a full recovery. Inflammation increases when COVID-19 severity increases. The lungs and endothelium will suffer harm when different pro-inflammatory cytokines are released. A cytokine storm is started when many immune cells produce cytokines and chemokines. The pro-inflammatory cytokine can increase angiogenesis, vascular permeability, keratin proliferation, and collagen production. Lung lesions are affected by certain disorders. In COVID-19 patients, angiogenesis, fibroblast activation, and collagen deposition all contribute to the repair of the lungs. The pathological outcome of acute or chronic interstitial pulmonary disease is lung fibrosis, characterized by abnormal collagen and extracellular matrix (ECM) deposition, the persistence of fibroblasts, failure of alveolar re-epithelization, and destruction of normal pulmonary architecture. The breakdown or buildup of ECM is influenced by the ratio of matrix metalloproteinase (MMP) and tissue inhibitor matrix metalloproteinase (TIMP). TIMP distribution, not MMP distribution, was the primary contributor to lung fibrosis. MMP expression is increased by the production of several hormones, cytokines (IL-1, IL-6), growth factors (TGF, TNF-), platelet-derived growth factor (PDGF), and basic fibroblast growth factor (bFGF).
ECM assistance is required for the alveoli to function normally. Excessive ECM breakdown and aberrant ECM remodelling are the root causes of many respiratory conditions, including pulmonary fibrosis. ECM buildup destroys the alveolar process, particularly by impairing alveolar-capillary diffusion. On radiological images, lung abnormalities can be seen as pneumonia in the bilateral ground-glass opacity basal, which results in hypoxia. In the lower portion, bilateral abnormalities predominated. COVID-19 ARDS, hypoxemia, bilateral infiltrates, and reduced lung compliance were the hallmarks of pneumonia type H. Despite the limited sensitivity, plain chest X-rays can detect lung abnormalities in COVID-19; they are inexpensive and simple. New infiltrates on chest radiographs were used to make the diagnosis of pneumonia.
Biomarkers of pulmonary interstitial abnormalities have received limited attention in the literature, including investigations on MMP and TIMP for lung abnormalities in COVID-19 patients. One of the MMP gelatinase family's more complicated forms, MMP-9, can break down ECM components. MMP-9 increases collagen and cytokine production, fibroblast migration, and TGF- stimulation. MMP-9 is among the MMPs that TIMP1 effectively inhibits. TIMP-1 binds to pro- or latent MMP-9. For ECM proteolysis to occur, MMP and TIMP must coexist in equilibrium. This study aimed to ascertain how MMP-9 and TIMP-1 affected abnormal chest X-rays, poor oxygenation, severity, and death.
Blood is taken from hospitalized COVID-19 patients to measure the serum concentrations of MMP-9 and TIMP-1. At the time of hospital admission, three reviewers assessed the severity after chest X-Rays, followed by a BRIXIA score. At the time of hospital discharge, patients were evaluated. The levels of MMP-9 and TIMP-1 were compared to Brixia scores, oxygen consumption, severity, and death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Severe | – | Diagnostic Test: MMP-9 and TIMP-1Non-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. |
| Severe | – | Diagnostic Test: MMP-9 and TIMP-1Severe 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hospitalized COVID-19 patients in Universitas Airlangga Surabaya, Indonesia, proven by positive swab RT-PCR COVID-19.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMP-9 and TIMP-1Examine level of serum MMP-9 and TIMP-1 | Diagnostic test | Non-Severe, Severe |
Primary outcome
Anatomical abnormalities of the lungs.
Time frame: Chest X-Ray checked 2-4 hours during admission in emergency room.
Anatomical of the lung measured by Chest X-ray abnormality, scored by Brixia Index.
Functional abnormalities of the lungs.
Time frame: Oxygen use and blood gas analysis checked 1-2 hours during admission in emergency room.
Functional of the lung measured by the oxygen used and Blood Gas Analysis.
2 secondary outcomes
Severity
Time frame: Severity measured when patient hospitalized at first time during inclusion of study (4-6 hours after admission).
Mortality
Time frame: Mortality measured when patient out from hospital during the study (end of study).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 32641873Lingeswaran 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.
- Background: PubMed 32850151Ojo 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.
- Background: PubMed 18083622Gill 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.
- Background: PubMed 33862337Signoroni 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.
- Background: PubMed 33795768Gu 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.
- Background: PubMed 16227332Elkington 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.
- Background: PubMed 34449310D 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.
- Background: PubMed 34286362Guizani 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.
- Individual participant dataSharing planned: Undecided. Researchers have not yet decided to share data, but they do not rule out other researchers wishing to be able to access primary research data. Other researchers can contact the principal investigator via email.
Related trials for Pulmonary Infection
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Amin, Prof. principal investigator
Airlangga University Faculty of Medicine: Universitas Airlangga Fakultas Kedokteran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Infection and COVID-19, run by Universitas Airlangga at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical abnormalities of the lungs. (time frame: Chest X-Ray checked 2-4 hours during admission in emergency room.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05844215, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.