Gastrointestinal Symptoms in COVID-19

NCT04691895 | Unknown

• 1 other identifier: GI-COVID19_01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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 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

1. 1.to evaluate long term consequences of COVID-19 on gastrointestinal symptoms
2. 2.to evaluate long term consequences of COVID-19 on the development of post-infection irritable bowel syndrome (PI-IBS)
3. 3.to evaluate long term consequences of COVID-19 on the development of post-infection dyspepsia
4. 4.to assess the clinical and laboratory predictors (risk factors) of post-infection gastrointestinal symptom development

Conditions

COVID19 Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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).

  12 months

• long term consequences of COVID-19 on gastrointestinal symptoms on the development of post-infection (PI) dyspepsia.

  12 months

• Identification of risk factors for post-infection gastrointestinal symptom development.

  12 months

Study Arms (2)

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

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

Interventions

SARS-CoV2 infection OTHER

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.

Patients admitted to hospital for COVID19 disease (case group)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Patients under mechanical ventilation
• Patients unable to report required data
• Current diagnosis of cancer

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

Related Publications (2)

• 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.

  PMID: 36591612 DERIVED

• Marasco 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.

  PMID: 34751672 DERIVED

Study Officials

• Giovanni Barbara, MD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 31, 2020
• Study Start: May 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2021
• Last Updated: January 5, 2021

Record last verified: 2020-12

Locations

IT (1)