Clinical trial NCT04355741: Gut Microbiota, "Spark and Flame" of COVID-19 Disease
Official title: Gut Microbiota, "Spark and Flame" of COVID-19 Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Gut microbiota
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: Hospital de São Francisco Xavier, Centro Hospitalar de Lisboa Ocidental
name: Centro Hospitalar Universitário São João
name: CUF Academic and Research Medical Center
name: Hospital CUF Infante Santo, S.A.
name: Centro de Medicina Laboratorial Germano de Sousa, S.A.
name: CINTESIS - Center for Health Technology and Services Research
First posted: 2020-04-21
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients admitted to Portuguese hospitals.

Brief summary: Elderly, hypertension, diabetes and cardiovascular diseases are risk factors for COVID-19 morbility and mortality. However, the real reason for this is not yet understood. It is well documented that gut microbiota has a critical role in health, particularly in the immune system and therefore, we propose that gut microbiota composition could affect vulnerability and disease outcomes of COVID-19.

Detailed description: In order to explore this hypothesis, we will analyse the gut microbiota of SARSCoV-2 infected patients categorized according to location: \[1\] ambulatory (self-isolation at home), \[2\] ward and \[1\] ICU; and severity.

Eligibility criteria: Inclusion Criteria:

* Adults of 18 years and above.
* COVID-19 patients.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Differences in gut microbiota composition between COVID-19 patients with different degrees of disease severity.
timeFrame: Stool samples of COVID-19 patients will be collected after subject enrollment (single point collection)
Secondary outcomes:
measure: Differences in gut microbiota composition between COVID-19 patients in relation to mortality.
timeFrame: Through study completion, an average of 3 months.
measure: Differences in gut microbiota composition between COVID-19 patients in relation to length of stay in hospitals.
timeFrame: Through study completion, an average of 3 months.
measure: Differences in gut microbiota composition between COVID-19 patients in relation to duration of mechanical ventilation.
timeFrame: Through study completion, an average of 3 months.
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital CUF Infante Santo, S.A.
city: Lisbon
country: Portugal
facility: Hospital de São Francisco Xavier
city: Oporto
country: Portugal
facility: Centro Hospitalar Universitário São João
Study officials:
affiliation: Universidade Nova de Lisboa
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital São Francisco Xavier
name: Pedro Póvoa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar Universitário São João
name: Cristina Granja, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Medicina Laboratorial Germano de Sousa, S.A.
name: Maria JR Sousa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Medicina Laboratorial Germano de Sousa, S.A.
name: José Leal, PhD
role: STUDY_CHAIR
References: