IBD - Inflammatory Bowel DiseaseNCT06774638
Diagnostic and Prognostic Biomarkers in SARS-CoV-2 Infections
An observational study of IBD - Inflammatory Bowel Disease and COVID - 19, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Literature data document that SARS-CoV-2 RNA is present not only in the respiratory tract but also in the feces of infected patients, suggesting a potential additional route of transmission: the oro-fecal route. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD - Inflammatory Bowel Disease, COVID - 19
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 4 Apr 2020to 31 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in the IBD unit with clinical diagnosis of SARS-CoV-2 infection
Who may be able to join
- Age > 18 years
- Collection of informed consent to participate in the study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Literature data document that SARS-CoV-2 RNA is present not only in the respiratory tract but also in the feces of infected patients, suggesting a potential additional route of transmission: the oro-fecal route. In this context, it becomes essential to have data on the use of serological tests in suspected SARS-CoV-2 patients and the presence of viral RNA in biological samples from affected patients, to quickly and reliably identify infected individuals and provide recommendations on the duration of patient isolation. In particular, such data could support the indication for contact isolation similar to that used for all highly contagious gastrointestinal infections, such as Clostridium difficile, with a longer duration than respiratory isolation. The objective of this study is to verify the presence of diagnostic and prognostic biomarkers in patients with SARS-CoV-2 infection.
Read the detailed description
- Sample Size Calculation
Given the exploratory nature of the study, no formal sample size calculation was performed. A total of 370 patients is expected to be enrolled.
- Data Analysis (as outlined in the approved protocol)
Data will be analyzed using t-tests (or Mann-Whitney tests, depending on the data type). The correlation between obtained results and clinical outcomes will be tested using Spearman's rank correlation coefficient to identify potential biomarkers.
For microbiota analysis, intra-sample diversity (alpha diversity) will be assessed using Faith's phylogenetic diversity metrics, observed OTUs, and the Shannon index. Inter-sample diversity (beta diversity) will be evaluated using weighted and unweighted UniFrac distances, which will serve as input for principal coordinates analysis (PCoA). PCoA plots, heatmaps, and bar plots will be created using the Made4 and Vegan packages in R. Statistical analysis will be conducted using the Vegan and Stats packages. The separation of data in PCoA will be tested using a permutation test with pseudo-F ratios (Adonis function in Vegan). Fisher's exact test will be used to assess the significance of differences between clusters obtained through hierarchical clustering analysis. The Wilcoxon test (for paired or unpaired data) will be employed to compare alpha and beta diversity, as well as the relative abundance of microbial groups (or functional groups) between subject groups and over time. Discriminatory features (taxa or genes) will be identified using Random Forests (Breiman, 2001). Microbiota sequences from healthy subjects, matched for age, sex, and BMI, will be retrieved from publicly accessible databases for comparative purposes. p-values will be adjusted for multiple comparisons using the Benjamini-Hochberg method. A false discovery rate <0.05 will be considered statistically significant.
Correlations between variables will be assessed using Kendall's correlation test with the cor.test function from the Stats package in R.
For microbiota analysis, intra-sample diversity (alpha diversity) will be assessed using Faith's phylogenetic diversity metrics, observed OTUs, and the Shannon index. Inter-sample diversity (beta diversity) will be evaluated using weighted and unweighted UniFrac distances, which will serve as input for principal coordinates analysis (PCoA). PCoA plots, heatmaps, and bar plots will be created using the Made4 and Vegan packages in R. Statistical analysis will be conducted using the Vegan and Stats packages. The separation of data in PCoA will be tested using a permutation test with pseudo-F ratios (Adonis function in Vegan). Fisher's exact test will be used to assess the significance of differences between clusters obtained through hierarchical clustering analysis. The Wilcoxon test (for paired or unpaired data) will be employed to compare alpha and beta diversity, as well as the relative abundance of microbial groups (or functional groups) between subject groups and over time. Discriminatory features (taxa or genes) will be identified using Random Forests (Breiman, 2001). Microbiota sequences from healthy subjects, matched for age, sex, and BMI, will be retrieved from publicly accessible databases for comparative purposes. p-values will be adjusted for multiple comparisons using the Benjamini-Hochberg method. A false discovery rate <0.05 will be considered statistically significant.
Correlations between variables will be assessed using Kendall's correlation test with the cor.test function from the Stats package in R.
- Conditions
- IBD - Inflammatory Bowel Disease, COVID - 19
- Medical subject headings
- Inflammatory Bowel Diseases, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective of this study is to verify the presence of diagnostic and prognostic biomarkers in patients with SARS-CoV-2 infection.
Evaluate the potential presence and persistence of SARS-CoV-2 RNA in the feces of clinically recovered patients with a negative nasopharyngeal swab.
Measured: At baseline, one time, during the hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start4 Apr 2020
- Primary completion31 Dec 2021
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD - Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Gionchetti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774638
- Sponsor's protocol ID
- MAC-2020
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Biomarkers in SARS-CoV-2 Infections
- ClinicalTrials.gov ID
- NCT06774638
- Acronym / sponsor ID
- MAC-2020
- Conditions
- IBD - Inflammatory Bowel Disease, COVID - 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 4 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 14 Jan 2025 (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.
Literature data document that SARS-CoV-2 RNA is present not only in the respiratory tract but also in the feces of infected patients, suggesting a potential additional route of transmission: the oro-fecal route. In this context, it becomes essential to have data on the use of serological tests in suspected SARS-CoV-2 patients and the presence of viral RNA in biological samples from affected patients, to quickly and reliably identify infected individuals and provide recommendations on the duration of patient isolation. In particular, such data could support the indication for contact isolation similar to that used for all highly contagious gastrointestinal infections, such as Clostridium difficile, with a longer duration than respiratory isolation. The objective of this study is to verify the presence of diagnostic and prognostic biomarkers in patients with SARS-CoV-2 infection.
Detailed description
- Sample Size Calculation
Given the exploratory nature of the study, no formal sample size calculation was performed. A total of 370 patients is expected to be enrolled.
- Data Analysis (as outlined in the approved protocol)
Data will be analyzed using t-tests (or Mann-Whitney tests, depending on the data type). The correlation between obtained results and clinical outcomes will be tested using Spearman's rank correlation coefficient to identify potential biomarkers.
For microbiota analysis, intra-sample diversity (alpha diversity) will be assessed using Faith's phylogenetic diversity metrics, observed OTUs, and the Shannon index. Inter-sample diversity (beta diversity) will be evaluated using weighted and unweighted UniFrac distances, which will serve as input for principal coordinates analysis (PCoA). PCoA plots, heatmaps, and bar plots will be created using the Made4 and Vegan packages in R. Statistical analysis will be conducted using the Vegan and Stats packages. The separation of data in PCoA will be tested using a permutation test with pseudo-F ratios (Adonis function in Vegan). Fisher's exact test will be used to assess the significance of differences between clusters obtained through hierarchical clustering analysis. The Wilcoxon test (for paired or unpaired data) will be employed to compare alpha and beta diversity, as well as the relative abundance of microbial groups (or functional groups) between subject groups and over time. Discriminatory features (taxa or genes) will be identified using Random Forests (Breiman, 2001). Microbiota sequences from healthy subjects, matched for age, sex, and BMI, will be retrieved from publicly accessible databases for comparative purposes. p-values will be adjusted for multiple comparisons using the Benjamini-Hochberg method. A false discovery rate <0.05 will be considered statistically significant.
Correlations between variables will be assessed using Kendall's correlation test with the cor.test function from the Stats package in R.
For microbiota analysis, intra-sample diversity (alpha diversity) will be assessed using Faith's phylogenetic diversity metrics, observed OTUs, and the Shannon index. Inter-sample diversity (beta diversity) will be evaluated using weighted and unweighted UniFrac distances, which will serve as input for principal coordinates analysis (PCoA). PCoA plots, heatmaps, and bar plots will be created using the Made4 and Vegan packages in R. Statistical analysis will be conducted using the Vegan and Stats packages. The separation of data in PCoA will be tested using a permutation test with pseudo-F ratios (Adonis function in Vegan). Fisher's exact test will be used to assess the significance of differences between clusters obtained through hierarchical clustering analysis. The Wilcoxon test (for paired or unpaired data) will be employed to compare alpha and beta diversity, as well as the relative abundance of microbial groups (or functional groups) between subject groups and over time. Discriminatory features (taxa or genes) will be identified using Random Forests (Breiman, 2001). Microbiota sequences from healthy subjects, matched for age, sex, and BMI, will be retrieved from publicly accessible databases for comparative purposes. p-values will be adjusted for multiple comparisons using the Benjamini-Hochberg method. A false discovery rate <0.05 will be considered statistically significant.
Correlations between variables will be assessed using Kendall's correlation test with the cor.test function from the Stats package in R.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the IBD unit with clinical diagnosis of SARS-CoV-2 infection
Key inclusion criteria (2 listed)
- Age > 18 years
- Collection of informed consent to participate in the study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The objective of this study is to verify the presence of diagnostic and prognostic biomarkers in patients with SARS-CoV-2 infection.
Time frame: At baseline, one time, during the hospitalization.
Evaluate the potential presence and persistence of SARS-CoV-2 RNA in the feces of clinically recovered patients with a negative nasopharyngeal swab.
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 14 Jan 2025.
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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.
Paolo Gionchetti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 IBD - Inflammatory Bowel Disease and COVID - 19, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 2 inclusion and 1 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 14 Jan 2025. 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 Italy. 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?
The objective of this study is to verify the presence of diagnostic and prognostic biomarkers in patients with SARS-CoV-2 infection. (time frame: At baseline, one time, during the hospitalization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.