COVID19 DiseaseNCT04691895
Gastrointestinal Symptoms in COVID-19
An observational study of COVID19 Disease, run by University of Bologna at 1 site in Italy.
Trial summary
The coronavirus disease 2019 (COVID-19) initially developed at the beginning of December 2019 in Whuan, Hubei province of China has spread all over the world. Beside the most common symptoms at onset of illness including fever, fatigue, dry cough, myalgia and dyspnoea, there are less common symptoms such as headache… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID19 Disease
- What is being tested?
- SARS-CoV2 infection
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 31 Dec 2021
- How long will I take part?
- 12 Months
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort will be composed by consecutively enrolled COVID19 confirmed inpatients (case group) and COVID19 negative patients hospitalized for other reasons (controls group) referred to the participants centres from May, 1 2020. From the beginning of the study (first patient enrolled in the centre), the enrolment will last for 1 month.
Who may be able to join
- Signed informed consent
- Age ≥18 years and ≤85 years
- Consecutive COVID19 confirmed patients (COVID +ve) (case group)
- Consecutive hospitalized COVID19 negative patients (COVID -ve) (control group)
- Ability to conform to study protocol
Who cannot join
- Patients under mechanical ventilation
- Patients unable to report required data
- Current diagnosis of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastrointestinal Symptoms of SARS-CoV-2 Infection: a Prospective Multicentre Study
The coronavirus disease 2019 (COVID-19) initially developed at the beginning of December 2019 in Whuan, Hubei province of China has spread all over the world. Beside the most common symptoms at onset of illness including fever, fatigue, dry cough, myalgia and dyspnoea, there are less common symptoms such as headache abdominal pain, diarrhoea, nausea and vomiting. The proportion of patients complaining gastrointestinal symptoms is variable between 3,4% and 17,0%. Interestingly, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) RNA has been reported to be detectable in 50% of patients' stool samples and in these patients around the 50% had diarrhoea.
SARS-CoV2 transmission has been reported to be through droplets. However, mounting evidence indicates that SARS-CoV2 has a tropism for the gastrointestinal tract and is excreted with faeces. Accordingly, a faecal-oral route of transmission of the virus has been recently postulated. Indeed, SARS-CoV2 binds to host ACE 2 receptors (ACE2) to entry into cells which are abundantly expressed by intestinal epithelial cells and regulate intestinal inflammation. Taken together, this evidence could provide a rational basis for the development of gastrointestinal symptoms reported by COVID19 infected patients.
Read more
Primary aim: to evaluate the prevalence and prognosis of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease Secondary aims
- to evaluate long term consequences of COVID-19 on gastrointestinal symptoms
- to evaluate long term consequences of COVID-19 on the development of post-infection irritable bowel syndrome (PI-IBS)
- to evaluate long term consequences of COVID-19 on the development of post-infection dyspepsia
- to assess the clinical and laboratory predictors (risk factors) of post-infection gastrointestinal symptom development
Read the detailed description
The investigators propose a multicentre observational prospective study according to the clinical routine practice of coronavirus disease 2019 (COVID-19) patients. All patients will be clinically evaluated at admission according to standard clinical practice. All data present in the inpatient medical record will be used for the study.
The study cohort will be composed by consecutively enrolled COVID19 confirmed inpatients (case group) and COVID19 negative patients hospitalized for other reasons (controls group) referred to the participants centres from May 1, 2020.
Patient's follow up will start at discharge and will continue for 12 months.
Definitions Confirmed COVID19 cases The definitions of COVID19 state are according to the World Health Organization (WHO) document released in March 2020.
A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms. Patients categorized as suspect or probable COVID19 cases will be excluded from enrolment.
COVID19 negative patients (controls) Consecutive COVID19 negative in-patients admitted for any clinical condition other than a primary gastrointestinal disease fulfilling the inclusion criteria.
Visits and evaluations After enrolment, all patients will be contacted telephonically at 1 month after discharge for reassessment of Gastrointestinal Symptom Rating Scale (GSRS). Subsequently, patients will be contacted every 6 months for a total of 12 months. At telephonic evaluation at 6 and 12 months after discharge patients will undergo the GSRS questionnaire, the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (R4DQ) and the hospital anxiety and depression scale (HADS) and thus the onset of PI-IBS will be recorded.
Data Management Data flow Data will be collected in custom electronic Case Report Forms (e-CRFs) on REDCap platform. System backups for data stored and records retention for the study data will be consistent with standard procedures.
Electronic Case Report Forms eCRFs are to be completed using RedCAP system. Sites will receive training and a have access to a manual for appropriate eCRF completion. eCRFs will be submitted electronically and should be handled in accordance with instructions. All eCRFs should be completed by designated, trained site staff. eCRFs should be reviewed and electronically signed and dated by the investigator or a designee.
Safety of Electronic data Data will be collected in an ad hoc electronic record storage. The creation and the management of electronic record storage will be evaluated preliminarily with institution information technology staff. Data will be collected in REDCap platform. Redcap platform is an online platform maintained in a server that is propriety of the institution. Access and data transfer from and to REDCap platform are managed under https protocol and 128-bit encryption wit SSL certificate (a secure connection with encrypted data transfer). The access at the site is allowed only for the investigators and require a user-specific password of at least 8 characters including number and special character. Redcap comes with a system of user privileges, so only the account of the principal investigator has the authorization to explore the entire dataset. The sub-investigators and data manager have limited authorizations,and can see only data that they entered personally. REDCap provider and the principal investigator guarantee that creation and management of username and password are compliant with privacy law.
The access of REDCap platform is regulated by law for protection of personal data. Administrative procedures on applications (e.g. user creation and suspension, study configuration, query creation, data mining) are pertinence of the principal investigator and his information technology support team. REDCap platform, to manage identity of people involved in the study, generates a unique identification number associated at every eCRF of the subject, that allow the investigators to maintain association with name and surname of the subject locally.
Data collected on REDCap, even if they do not allow to associate data with a specific subject or to recognize the subject, are registered in double-key SSL encryption, and maintained with AES 128 encryption. As regulated by law for protection of personal data, REDCap and the principal investigator guarantee the weekly backup of data in a password-protected storage.
Data will be accessed only by principal investigator and his support team (sub investigators), and they will have confidentiality obligation.
- Conditions
- COVID19 Disease
- Being tested
- SARS-CoV2 infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV2 infectionOther
Confirmed COVID19 cases The definitions of COVID19 state are according to the WHO document released in March 2020. A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to hospital for COVID19 disease (case group) | The study cohort will be composed by consecutively enrolled COVID19 confirmed inpatients (case group)
Inclusion criteria:
* Signed informed consent
* Age ≥18 years and ≤85 years
* Consecutive COVID19 confirmed patients (COVID +ve)
* Ability to conform to study protocol
Exclusion criteria:
* Patients under mechanical ventilation
* Patients unable to report required data
* Current diagnosis of cancer Receives: Other: SARS-CoV2 infection | |
| Patients admitted to hospital in absence of COVID19 disease (control group) | The study cohort will be composed by consecutively enrolled COVID19 negative patients hospitalized for other reasons (controls group) Inclusion criteria: * Signed informed consent * Age ≥18 years and ≤85 years * Consecutive hospitalized COVID19 negative patients (COVID -ve) * Ability to conform to study protocol Exclusion criteria: * Patients under mechanical ventilation * Patients unable to report required data * Current diagnosis of cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease as assessed by GSRS questionnaire
For the primary aims of the study, the presence of gastrointestinal symptoms at admission and at follow-up made 1 month after discharge will be evaluated.
In particular, the validated Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (a 7-points Likert scale) will be used to assess the prevalence of gastrointestinal symptoms.
Measured: one month
Prognosis of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease
For the prognosis, mortality rates (%) at one month will be evaluated.
Measured: one month
Secondary outcomes (3)
Long term consequences of COVID-19 on gastrointestinal symptoms on the development of post-infection (PI) irritable bowel syndrome (IBS).
to evaluate long term consequences of COVID-19 on the development of PI IBS, the validated Rome IV Diagnostic Questionnaire for Irritable Bowel syndrome will be used. This questionnaire translates the Rome IV diagnostic criteria into questions that can be understood and reported by patients, assisting the clinicians in arriving at a positive diagnosis. The prevalence (%) of new IBS diagnosis will be evaluated by this questionnaire.
Measured: 12 months
long term consequences of COVID-19 on gastrointestinal symptoms on the development of post-infection (PI) dyspepsia.
to evaluate long term consequences of COVID-19 on the development of PI dyspepsia, the validated Rome IV Diagnostic Questionnaire for Dyspepsia will be used. This questionnaire translates the Rome IV diagnostic criteria into questions that can be understood and reported by patients, assisting the clinicians in arriving at a positive diagnosis. The prevalence (%) of new dyspepsia diagnosis will be evaluated by this questionnaire.
Measured: 12 months
Identification of risk factors for post-infection gastrointestinal symptom development.
Data recorded at admission and used for the primary aims of the study will be tested as predictors of post-infection gastrointestinal symptoms onset occurring within a specific time frame using the Logistic Regression or Cox regression method. Subsequently to confirm their independent predictive value, the variables with p <0.1 will be studied in a multivariate logistic or Cox model.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 May 2020
- Primary completion30 Sep 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID19 DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Barbara, University of Bologna
- Investigators
- Giovanni Barbara, MD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691895
- Sponsor's protocol ID
- GI-COVID19_01
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be collected in an ad hoc electronic record storage. The creation and the management of electronic record storage will be evaluated preliminarily with institution information technology staff. Data will be collected in REDCap platform. Data will be accessed only by principal investigator and his support team (sub investigators), and they will have confidentiality obligation.
Publications
Marasco G, Cremon C, Barbaro MR, Cacciari G, Falangone F, Kagramanova A, Bordin D, Drug V, Miftode E, Fusaroli P, Mohamed SY, Ricci C, Bellini M, Rahman MM, Melcarne L, Santos J, Lobo B, Bor S, Yapali S, Akyol D, Sapmaz FP, Urun YY, Eskazan T, Celebi A, Kacmaz H, Ebik B, Binicier HC, Bugdayci MS, Yagci MB, Pullukcu H, Kaya BY, Tureyen A, Hatemi I, Koc ES, Sirin G, Caliskan AR, Bengi G, Alis EE, Lukic S, Trajkovska M, Hod K, Dumitrascu D, Pietrangelo A, Corradini E, Simren M, Sjolund J, Tornkvist N, Ghoshal UC, Kolokolnikova O, Colecchia A, Serra J, Maconi G, De Giorgio R, Danese S, Portincasa P, Di Sabatino A, Maggio M, Philippou E, Lee YY, Salvi D, Venturi A, Borghi C, Zoli M, Gionchetti P, Viale P, Stanghellini V, Barbara G; GI-COVID19 study group. Post COVID-19 irritable bowel syndrome. Gut. 2022 Dec 9:gutjnl-2022-328483. doi: 10.1136/gutjnl-2022-328483. Online ahead of print.
PubMed 36591612Marasco G, Cremon C, Barbaro MR, Salvi D, Cacciari G, Kagramanova A, Bordin D, Drug V, Miftode E, Fusaroli P, Mohamed SY, Ricci C, Bellini M, Rahman MM, Melcarne L, Santos J, Lobo B, Bor S, Yapali S, Akyol D, Sapmaz FP, Urun YY, Eskazan T, Celebi A, Kacmaz H, Ebik B, Binicier HC, Bugdayci MS, Yagci MB, Pullukcu H, Kaya BY, Tureyen A, Hatemi I, Koc ES, Sirin G, Caliskan AR, Bengi G, Alis EE, Lukic S, Trajkovska M, Hod K, Dumitrascu D, Pietrangelo A, Corradini E, Simren M, Sjolund J, Tornkvist N, Ghoshal UC, Kolokolnikova O, Colecchia A, Serra J, Maconi G, De Giorgio R, Danese S, Portincasa P, Di Stefano M, Maggio M, Philippou E, Lee YY, Venturi A, Borghi C, Zoli M, Gionchetti P, Viale P, Stanghellini V, Barbara G; and the GI-COVID19 Study Group. Prevalence of Gastrointestinal Symptoms in Severe Acute Respiratory Syndrome Coronavirus 2 Infection: Results of the Prospective Controlled Multinational GI-COVID-19 Study. Am J Gastroenterol. 2022 Jan 1;117(1):147-157. doi: 10.14309/ajg.0000000000001541.
PubMed 34751672
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Symptoms of SARS-CoV-2 Infection: a Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT04691895
- Acronym / sponsor ID
- GI-COVID19_01
- Conditions
- COVID19 Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 31 Dec 2020 (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.
The coronavirus disease 2019 (COVID-19) initially developed at the beginning of December 2019 in Whuan, Hubei province of China has spread all over the world. Beside the most common symptoms at onset of illness including fever, fatigue, dry cough, myalgia and dyspnoea, there are less common symptoms such as headache abdominal pain, diarrhoea, nausea and vomiting. The proportion of patients complaining gastrointestinal symptoms is variable between 3,4% and 17,0%. Interestingly, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) RNA has been reported to be detectable in 50% of patients' stool samples and in these patients around the 50% had diarrhoea.
SARS-CoV2 transmission has been reported to be through droplets. However, mounting evidence indicates that SARS-CoV2 has a tropism for the gastrointestinal tract and is excreted with faeces. Accordingly, a faecal-oral route of transmission of the virus has been recently postulated. Indeed, SARS-CoV2 binds to host ACE 2 receptors (ACE2) to entry into cells which are abundantly expressed by intestinal epithelial cells and regulate intestinal inflammation. Taken together, this evidence could provide a rational basis for the development of gastrointestinal symptoms reported by COVID19 infected patients.
Primary aim: to evaluate the prevalence and prognosis of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease Secondary aims
- to evaluate long term consequences of COVID-19 on gastrointestinal symptoms
- to evaluate long term consequences of COVID-19 on the development of post-infection irritable bowel syndrome (PI-IBS)
- to evaluate long term consequences of COVID-19 on the development of post-infection dyspepsia
- to assess the clinical and laboratory predictors (risk factors) of post-infection gastrointestinal symptom development
Detailed description
The investigators propose a multicentre observational prospective study according to the clinical routine practice of coronavirus disease 2019 (COVID-19) patients. All patients will be clinically evaluated at admission according to standard clinical practice. All data present in the inpatient medical record will be used for the study.
The study cohort will be composed by consecutively enrolled COVID19 confirmed inpatients (case group) and COVID19 negative patients hospitalized for other reasons (controls group) referred to the participants centres from May 1, 2020.
Patient's follow up will start at discharge and will continue for 12 months.
Definitions Confirmed COVID19 cases The definitions of COVID19 state are according to the World Health Organization (WHO) document released in March 2020.
A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms. Patients categorized as suspect or probable COVID19 cases will be excluded from enrolment.
COVID19 negative patients (controls) Consecutive COVID19 negative in-patients admitted for any clinical condition other than a primary gastrointestinal disease fulfilling the inclusion criteria.
Visits and evaluations After enrolment, all patients will be contacted telephonically at 1 month after discharge for reassessment of Gastrointestinal Symptom Rating Scale (GSRS). Subsequently, patients will be contacted every 6 months for a total of 12 months. At telephonic evaluation at 6 and 12 months after discharge patients will undergo the GSRS questionnaire, the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (R4DQ) and the hospital anxiety and depression scale (HADS) and thus the onset of PI-IBS will be recorded.
Data Management Data flow Data will be collected in custom electronic Case Report Forms (e-CRFs) on REDCap platform. System backups for data stored and records retention for the study data will be consistent with standard procedures.
Electronic Case Report Forms eCRFs are to be completed using RedCAP system. Sites will receive training and a have access to a manual for appropriate eCRF completion. eCRFs will be submitted electronically and should be handled in accordance with instructions. All eCRFs should be completed by designated, trained site staff. eCRFs should be reviewed and electronically signed and dated by the investigator or a designee.
Safety of Electronic data Data will be collected in an ad hoc electronic record storage. The creation and the management of electronic record storage will be evaluated preliminarily with institution information technology staff. Data will be collected in REDCap platform. Redcap platform is an online platform maintained in a server that is propriety of the institution. Access and data transfer from and to REDCap platform are managed under https protocol and 128-bit encryption wit SSL certificate (a secure connection with encrypted data transfer). The access at the site is allowed only for the investigators and require a user-specific password of at least 8 characters including number and special character. Redcap comes with a system of user privileges, so only the account of the principal investigator has the authorization to explore the entire dataset. The sub-investigators and data manager have limited authorizations,and can see only data that they entered personally. REDCap provider and the principal investigator guarantee that creation and management of username and password are compliant with privacy law.
The access of REDCap platform is regulated by law for protection of personal data. Administrative procedures on applications (e.g. user creation and suspension, study configuration, query creation, data mining) are pertinence of the principal investigator and his information technology support team. REDCap platform, to manage identity of people involved in the study, generates a unique identification number associated at every eCRF of the subject, that allow the investigators to maintain association with name and surname of the subject locally.
Data collected on REDCap, even if they do not allow to associate data with a specific subject or to recognize the subject, are registered in double-key SSL encryption, and maintained with AES 128 encryption. As regulated by law for protection of personal data, REDCap and the principal investigator guarantee the weekly backup of data in a password-protected storage.
Data will be accessed only by principal investigator and his support team (sub investigators), and they will have confidentiality obligation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to hospital for COVID19 disease (case group) | – | Other: SARS-CoV2 infectionThe study cohort will be composed by consecutively enrolled COVID19 confirmed inpatients (case group) Inclusion criteria: * Signed informed consent * Age ≥18 years and ≤85 years * Consecutive COVID19 confirmed patients (COVID +ve) * Ability to conform to study protocol Exclusion criteria: * Patients under mechanical ventilation * Patients unable to report required data * Current diagnosis of cancer |
| Patients admitted to hospital in absence of COVID19 disease (control group) | – | –The study cohort will be composed by consecutively enrolled COVID19 negative patients hospitalized for other reasons (controls group) Inclusion criteria: * Signed informed consent * Age ≥18 years and ≤85 years * Consecutive hospitalized COVID19 negative patients (COVID -ve) * Ability to conform to study protocol Exclusion criteria: * Patients under mechanical ventilation * Patients unable to report required data * Current diagnosis of cancer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort will be composed by consecutively enrolled COVID19 confirmed inpatients (case group) and COVID19 negative patients hospitalized for other reasons (controls group) referred to the participants centres from May, 1 2020. From the beginning of the study (first patient enrolled in the centre), the enrolment will last for 1 month.
Key inclusion criteria (5 listed)
- Signed informed consent
- Age ≥18 years and ≤85 years
- Consecutive COVID19 confirmed patients (COVID +ve) (case group)
- Consecutive hospitalized COVID19 negative patients (COVID -ve) (control group)
- Ability to conform to study protocol
Key exclusion criteria (3 listed)
- Patients under mechanical ventilation
- Patients unable to report required data
- Current diagnosis of cancer
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 |
|---|---|---|
| SARS-CoV2 infectionConfirmed COVID19 cases The definitions of COVID19 state are according to the WHO document released in March 2020. A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms. | Other | Patients admitted to hospital for COVID19 disease (case group) |
Primary outcome
Prevalence of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease as assessed by GSRS questionnaire
Time frame: one month
For the primary aims of the study, the presence of gastrointestinal symptoms at admission and at follow-up made 1 month after discharge will be evaluated. In particular, the validated Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (a 7-points Likert scale) will be used to assess the prevalence of gastrointestinal symptoms.
Prognosis of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease
Time frame: one month
For the prognosis, mortality rates (%) at one month will be evaluated.
3 secondary outcomes
Long term consequences of COVID-19 on gastrointestinal symptoms on the development of post-infection (PI) irritable bowel syndrome (IBS).
Time frame: 12 months
long term consequences of COVID-19 on gastrointestinal symptoms on the development of post-infection (PI) dyspepsia.
Time frame: 12 months
Identification of risk factors for post-infection gastrointestinal symptom development.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 36591612Marasco G, Cremon C, Barbaro MR, Cacciari G, Falangone F, Kagramanova A, Bordin D, Drug V, Miftode E, Fusaroli P, Mohamed SY, Ricci C, Bellini M, Rahman MM, Melcarne L, Santos J, Lobo B, Bor S, Yapali S, Akyol D, Sapmaz FP, Urun YY, Eskazan T, Celebi A, Kacmaz H, Ebik B, Binicier HC, Bugdayci MS, Yagci MB, Pullukcu H, Kaya BY, Tureyen A, Hatemi I, Koc ES, Sirin G, Caliskan AR, Bengi G, Alis EE, Lukic S, Trajkovska M, Hod K, Dumitrascu D, Pietrangelo A, Corradini E, Simren M, Sjolund J, Tornkvist N, Ghoshal UC, Kolokolnikova O, Colecchia A, Serra J, Maconi G, De Giorgio R, Danese S, Portincasa P, Di Sabatino A, Maggio M, Philippou E, Lee YY, Salvi D, Venturi A, Borghi C, Zoli M, Gionchetti P, Viale P, Stanghellini V, Barbara G; GI-COVID19 study group. Post COVID-19 irritable bowel syndrome. Gut. 2022 Dec 9:gutjnl-2022-328483. doi: 10.1136/gutjnl-2022-328483. Online ahead of print.
- Derived from this study: PubMed 34751672Marasco G, Cremon C, Barbaro MR, Salvi D, Cacciari G, Kagramanova A, Bordin D, Drug V, Miftode E, Fusaroli P, Mohamed SY, Ricci C, Bellini M, Rahman MM, Melcarne L, Santos J, Lobo B, Bor S, Yapali S, Akyol D, Sapmaz FP, Urun YY, Eskazan T, Celebi A, Kacmaz H, Ebik B, Binicier HC, Bugdayci MS, Yagci MB, Pullukcu H, Kaya BY, Tureyen A, Hatemi I, Koc ES, Sirin G, Caliskan AR, Bengi G, Alis EE, Lukic S, Trajkovska M, Hod K, Dumitrascu D, Pietrangelo A, Corradini E, Simren M, Sjolund J, Tornkvist N, Ghoshal UC, Kolokolnikova O, Colecchia A, Serra J, Maconi G, De Giorgio R, Danese S, Portincasa P, Di Stefano M, Maggio M, Philippou E, Lee YY, Venturi A, Borghi C, Zoli M, Gionchetti P, Viale P, Stanghellini V, Barbara G; and the GI-COVID19 Study Group. Prevalence of Gastrointestinal Symptoms in Severe Acute Respiratory Syndrome Coronavirus 2 Infection: Results of the Prospective Controlled Multinational GI-COVID-19 Study. Am J Gastroenterol. 2022 Jan 1;117(1):147-157. doi: 10.14309/ajg.0000000000001541.
- Individual participant dataSharing planned: Undecided. Data will be collected in an ad hoc electronic record storage. The creation and the management of electronic record storage will be evaluated preliminarily with institution information technology staff. Data will be collected in REDCap platform. Data will be accessed only by principal investigator and his support team (sub investigators), and they will have confidentiality obligation.
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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.
Giovanni Barbara, MD principal investigator
University of 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 COVID19 Disease, run by University of 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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?
Results are not available in the source record.
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?
Prevalence of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease as assessed by GSRS questionnaire (time frame: one month). 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 NCT04691895, which also lists 2 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 5 Jan 2021.