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

Completed

• Conditions: COVID-19
• Interventions: Other: Exposure

• 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

Arm && Interventions

Group	Intervention	Description
Ambulatory	Exposure	Patients that are self-isolated at home
ICU	Exposure	Patients that are in the ICU of the hospital
Ward	Exposure	Patients that are in an isolated room at the hospital

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