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Completed

NCT Number: NCT04355741

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital CUF Infante Santo, S.A., Lisbon, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

Exposure

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Collaborators

  • CINTESIS - Center for Health Technology and Services Research
  • CUF Academic and Research Medical Center
  • Centro Hospitalar De São João, E.P.E.
  • Centro Hospitalar Lisboa Ocidental
  • Centro de Medicina Laboratorial Germano de Sousa, S.A.
  • Hospital CUF Infante Santo, S.A.

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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