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

Recruiting

• Conditions: COVID-19; Corona Virus Infection; Coronavirus; Coronavirus 19; COVID 19; Gut Microbiome; COVID; Coronaviridae Infections; Coronavirus-19; Gastrointestinal Microbiome
• Interventions: Other: There is no intervention in this study

• Registration Number: NCT04359836
• Lead Sponsor: ProgenaBiome

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-24
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05
• Primary Completion: 2024-04-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General Population	There is no intervention in this study	The general population will have their microbiome sequenced from stool samples provided.

Primary Outcome Measures

Name	Time	Method
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing	One year	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.

Secondary Outcome Measures

Name	Time	Method
Validation of Sequencing Methods	One year	To validate the methods used to sequence samples

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States