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

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ClinicalTrials.gov Identifier: NCT04355741
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : August 25, 2020
Sponsor:
Collaborators:
NOVA Medical School of Universidade NOVA de Lisboa
Hospital de São Francisco Xavier, Centro Hospitalar de Lisboa Ocidental
Centro Hospitalar Universitário São João
CUF Academic and Research Medical Center
Hospital CUF Infante Santo, S.A.
Centro de Medicina Laboratorial Germano de Sousa, S.A.
CINTESIS - Center for Health Technology and Services Research
Information provided by (Responsible Party):
Universidade Nova de Lisboa

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.

Condition or disease Intervention/treatment
COVID-19 Other: Exposure

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.

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Study Type : Observational
Actual Enrollment : 115 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Gut Microbiota, "Spark and Flame" of COVID-19 Disease
Actual Study Start Date : April 20, 2020
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 16, 2020

Group/Cohort Intervention/treatment
Ambulatory
Patients that are self-isolated at home
Other: Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

Ward
Patients that are in an isolated room at the hospital
Other: Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

ICU
Patients that are in the ICU of the hospital
Other: Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.




Primary Outcome Measures :
  1. Differences in gut microbiota composition between COVID-19 patients with different degrees of disease severity. [ Time Frame: Stool samples of COVID-19 patients will be collected after subject enrollment (single point collection) ]

Secondary Outcome Measures :
  1. Differences in gut microbiota composition between COVID-19 patients in relation to mortality. [ Time Frame: Through study completion, an average of 3 months. ]
  2. Differences in gut microbiota composition between COVID-19 patients in relation to length of stay in hospitals. [ Time Frame: Through study completion, an average of 3 months. ]
  3. Differences in gut microbiota composition between COVID-19 patients in relation to duration of mechanical ventilation. [ Time Frame: Through study completion, an average of 3 months. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 patients admitted to Portuguese hospitals.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355741


Locations
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Portugal
Hospital CUF Infante Santo, S.A.
Lisbon, Portugal
Hospital de São Francisco Xavier
Lisbon, Portugal
Centro Hospitalar Universitário São João
Oporto, Portugal
Sponsors and Collaborators
Universidade Nova de Lisboa
NOVA Medical School of Universidade NOVA de Lisboa
Hospital de São Francisco Xavier, Centro Hospitalar de Lisboa Ocidental
Centro Hospitalar Universitário São João
CUF Academic and Research Medical Center
Hospital CUF Infante Santo, S.A.
Centro de Medicina Laboratorial Germano de Sousa, S.A.
CINTESIS - Center for Health Technology and Services Research
Investigators
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Principal Investigator: Conceição Calhau, PhD NOVA Medical School of Universidade NOVA de Lisboa
Principal Investigator: Pedro Póvoa, PhD Hospital São Francisco Xavier
Principal Investigator: Cristina Granja, PhD Centro Hospitalar Universitário São João
Principal Investigator: Maria JR Sousa, PhD Centro de Medicina Laboratorial Germano de Sousa, S.A.
Study Chair: José Leal, PhD Centro de Medicina Laboratorial Germano de Sousa, S.A.
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Responsible Party: Universidade Nova de Lisboa
ClinicalTrials.gov Identifier: NCT04355741    
Other Study ID Numbers: COVID19_Microbiota
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidade Nova de Lisboa:
COVID-19
Gut microbiota