A Study to Explore the Role of Gut Flora in COVID-19 Infe... | NCT04359836

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

NCT04359836

Sponsor

ProgenaBiome

Status

Recruiting

Last Update Posted

Jun 5, 2025Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

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

Interventions

There is no intervention in this study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2020Actual

Primary Completion Date

Apr 30, 2026Estimated

Completion Date

Jul 31, 2027Estimated

First Submitted Date

Apr 20, 2020

First Submission Date that Met QC Criteria

Apr 20, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention in this study	Other	There is no intervention in this study	General Population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	One year

Secondary Outcomes

Measure	Description	Time Frame
Validation of Sequencing Methods	To validate the methods used to sequence samples	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults 18 and older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sabine Hazan, MD	Contact	805-339-0549		drsabinehazan@progenabiome.com
Jordan Daniels, MS	Contact	217-494-6692		jordan@progenabiome.com

Overall Officials

Name	Affiliation	Role
Sabine Hazan, MD	ProgenaBiome	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ProgenaBiome	Recruiting	Ventura	California	93003	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33516247	Derived	Papoutsis A, Borody T, Dolai S, Daniels J, Steinberg S, Barrows B, Hazan S. Detection of SARS-CoV-2 from patient fecal samples by whole genome sequencing. Gut Pathog. 2021 Jan 30;13(1):7. doi: 10.1186/s13099-021-00398-5.

ID	Term
D000086382	COVID-19
D018352	Coronavirus Infections
D003333	Coronaviridae Infections

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections