MedTrace Logo

Gastrointestinal Symptoms in COVID-19

NCT04691895 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2021-01-05

No results posted yet for this study

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

Conditions

  • COVID19 Disease

Interventions

OTHER

SARS-CoV2 infection

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.

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Giovanni Barbara, MD · University of Bologna

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2020-09-30
Completion
2021-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04691895 on ClinicalTrials.gov