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

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ClinicalTrials.gov Identifier: NCT04355741
Recruitment Status : Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 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 with [1] mild disease (self-isolation at home), [2] severe disease (room isolation in hospital) and [3] critical patients (hospital ICU).

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Gut Microbiota, "Spark and Flame" of COVID-19 Disease
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

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

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

Critical patients
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 hospitals from Lisbon and Oporto.
Criteria

Inclusion Criteria:

  • Adults of 18 years and above.
  • COVID-19 patients.
  • Available to comply with study protocol and sign informed consent.

Exclusion Criteria:

  • Anyone unable to provide informed consent.

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


Contacts
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Contact: Conceição Calhau, PhD 00351 218803035 ext 20401 ccalhau@nms.unl.pt
Contact: André Rosário, PhD 00351934447642 andrerosario@med.up.pt

Locations
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Portugal
Hospital CUF Infante Santo, S.A.
Lisbon, Portugal
Contact: Gonçalo Marcelino         
Hospital de São Francisco Xavier
Lisbon, Portugal
Contact: Pedro Póvoa, PhD         
Centro Hospitalar Universitário São João
Oporto, Portugal
Contact: Cristina Granja, PhD         
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: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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