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

Sponsor

ProgenaBiome (Other)

Overall Status

Recruiting

CT.gov ID

NCT04359836

Collaborator

(none)

250

Enrollment

Location

63.5

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gut Microbiome Gastrointestinal Microbiome COVID COVID-19 Corona Virus Infection Coronavirus Coronaviridae Infections Coronavirus 19 Coronavirus-19 COVID 19	Other: There is no intervention in this study

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 Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Apr 16, 2020

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
General Population The general population will have their microbiome sequenced from stool samples provided.	Other: There is no intervention in this study There is no intervention in this study

Arm

Intervention/Treatment

General Population

The general population will have their microbiome sequenced from stool samples provided.

Other: There is no intervention in this study

There is no intervention in this study

Outcome Measures

Primary Outcome Measures

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

Validation of Sequencing Methods [One year]
To validate the methods used to sequence samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
Male or female of 18 years of age or older
Diagnosis of COVID-19 infection by RT- PCR within 1 week of Screening

Exclusion Criteria:

Refusal to sign informed consent form
History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
Postoperative stoma, ostomy, or ileoanal pouch
Treatment with total parenteral nutrition