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

Completed

• Conditions: COVID-19

• Registration Number: NCT04355741
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-17
• Study Start: 2020-04-20
• Study First Posted: 2020-04-21
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Hospital CUF Infante Santo, S.A.; 🇵🇹 Lisbon, Portugal

Hospital de São Francisco Xavier; 🇵🇹 Lisbon, Portugal

Centro Hospitalar Universitário São João; 🇵🇹 Oporto, Portugal