Gut Microbiota, "Spark and Flame" of COVID-19 Disease

NCT ID: NCT04355741

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-07-16

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ambulatory

Patients that are self-isolated at home

Exposure

Intervention Type OTHER

Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

Ward

Patients that are in an isolated room at the hospital

Exposure

Intervention Type OTHER

Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

ICU

Patients that are in the ICU of the hospital

Exposure

Intervention Type OTHER

Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

Interventions

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Exposure

Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de São Francisco Xavier, Centro Hospitalar de Lisboa Ocidental

UNKNOWN

Sponsor Role collaborator

Centro Hospitalar Universitário São João

UNKNOWN

Sponsor Role collaborator

CUF Academic and Research Medical Center

UNKNOWN

Sponsor Role collaborator

Hospital CUF Infante Santo, S.A.

UNKNOWN

Sponsor Role collaborator

Centro de Medicina Laboratorial Germano de Sousa, S.A.

UNKNOWN

Sponsor Role collaborator

CINTESIS - Center for Health Technology and Services Research

UNKNOWN

Sponsor Role collaborator

Universidade Nova de Lisboa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Conceição Calhau, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Nova de Lisboa

Pedro Póvoa, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital São Francisco Xavier

Cristina Granja, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Universitário São João

Maria JR Sousa, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro de Medicina Laboratorial Germano de Sousa, S.A.

José Leal, PhD

Role: STUDY_CHAIR

Centro de Medicina Laboratorial Germano de Sousa, S.A.

Locations

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Hospital CUF Infante Santo, S.A.

Lisbon, , Portugal

Site Status

Hospital de São Francisco Xavier

Lisbon, , Portugal

Site Status

Centro Hospitalar Universitário São João

Porto, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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COVID19_Microbiota

Identifier Type: -

Identifier Source: org_study_id

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