A Study to Explore the Role of Gut Flora in COVID-19 Infection

ProgenaBiome250 enrolled

Overview

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

In this study the stool of patients who are being treated for COVID-19 will be tested during treatment and then again following treatment to determine if the virus is shed in the stool during infection, afterwards, or both.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Gut Microbiome Gastrointestinal Microbiome COVID COVID-19 Corona Virus Infection Coronavirus Coronaviridae Infections Coronavirus 19

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. Male or female of 18 years of age or older 3. Diagnosis of COVID-19 infection by RT- PCR within 1 week of Screening Exclusion Criteria: 1. Refusal to sign informed consent form 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. Postoperative stoma, ostomy, or ileoanal pouch 4. Treatment with total parenteral nutrition

Outcomes

Primary Outcomes

Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.

Time frame: One year

Secondary Outcomes

Validation of Sequencing Methods

To validate the methods used to sequence samples

Time frame: One year

Data from ClinicalTrials.gov

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