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

NCT04355741 | Completed

• 1 other identifier: COVID19_Microbiota
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

COVID-19; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Differences in gut microbiota composition between COVID-19 patients with different degrees of disease severity.

  Stool samples of COVID-19 patients will be collected after subject enrollment (single point collection)

Secondary Outcomes (3)

• Differences in gut microbiota composition between COVID-19 patients in relation to mortality.

  Through study completion, an average of 3 months.

• Differences in gut microbiota composition between COVID-19 patients in relation to length of stay in hospitals.

  Through study completion, an average of 3 months.

• Differences in gut microbiota composition between COVID-19 patients in relation to duration of mechanical ventilation.

  Through study completion, an average of 3 months.

Study Arms (3)

Ambulatory

Patients that are self-isolated at home

Other: Exposure

Ward

Patients that are in an isolated room at the hospital

Other: Exposure

ICU

Patients that are in the ICU of the hospital

Other: Exposure

Interventions

Exposure OTHER

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

Ambulatory; ICU; Ward

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients admitted to Portuguese hospitals.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Hospital de São Francisco Xavier, Centro Hospitalar de Lisboa Ocidental: collaborator
• Centro Hospitalar Universitário São João: collaborator
• CUF Academic and Research Medical Center: collaborator
• Hospital CUF Infante Santo, S.A.: collaborator
• Centro de Medicina Laboratorial Germano de Sousa, S.A.: collaborator
• CINTESIS - Center for Health Technology and Services Research: collaborator

Study Sites (3)

Hospital CUF Infante Santo, S.A.

Lisbon, Portugal

Location

Hospital de São Francisco Xavier

Lisbon, Portugal

Location

Centro Hospitalar Universitário São João

Porto, Portugal

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Conceição Calhau, PhD

  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.

  PRINCIPAL INVESTIGATOR

• José Leal, PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: April 20, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 16, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)