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
1
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.

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

ArmIntervention/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

  1. 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

  1. 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:
  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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1ProgenaBiomeVenturaCaliforniaUnited States93003

Sponsors and Collaborators

  • ProgenaBiome

Investigators

  • Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ProgenaBiome
ClinicalTrials.gov Identifier:
NCT04359836
Other Study ID Numbers:
  • PRG-041
First Posted:
Apr 24, 2020
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ProgenaBiome
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021