- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04359836
A Study to Explore the Role of Gut Flora in COVID-19 Infection
September 2, 2021 updated by: ProgenaBiome
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Ventura, California, United States, 93003
- Recruiting
- ProgenaBiome
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults 18 and older
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
General Population
The general population will have their microbiome sequenced from stool samples provided.
|
There is no intervention in this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
Time Frame: 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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of Sequencing Methods
Time Frame: One year
|
To validate the methods used to sequence samples
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2020
Primary Completion (Anticipated)
April 30, 2024
Study Completion (Anticipated)
July 31, 2025
Study Registration Dates
First Submitted
April 20, 2020
First Submitted That Met QC Criteria
April 20, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 2, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRG-041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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