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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355741
• Other study ID #: COVID19_Microbiota
• Status: Completed
• Start date: April 20, 2020
• Est. completion date: July 16, 2020

Study information

• Verified date: August 2020
• Source: Universidade Nova de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 16, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults of 18 years and above.

• COVID-19 patients.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

Locations

Country	Name	City	State
Portugal	Hospital CUF Infante Santo, S.A.	Lisbon
Portugal	Hospital de São Francisco Xavier	Lisbon
Portugal	Centro Hospitalar Universitário São João	Oporto

Sponsors (8)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Centro de Medicina Laboratorial Germano de Sousa, S.A., Centro Hospitalar Universitário São João, CINTESIS - Center for Health Technology and Services Research, CUF Academic and Research Medical Center, Hospital CUF Infante Santo, S.A., Hospital de São Francisco Xavier, Centro Hospitalar de Lisboa Ocidental, NOVA Medical School of Universidade NOVA de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Differences in gut microbiota composition between COVID-19 patients in relation to mortality.		Through study completion, an average of 3 months.
Secondary	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.
Secondary	Differences in gut microbiota composition between COVID-19 patients in relation to duration of mechanical ventilation.		Through study completion, an average of 3 months.