A Study to Explore the Role of Gut Flora in COVID-19 Infection
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04359836 |
Recruitment Status :
Recruiting
First Posted : April 24, 2020
Last Update Posted : September 5, 2021
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Condition or disease | Intervention/treatment |
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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 |
Study Type : | Observational |
Estimated 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 : | April 16, 2020 |
Estimated Primary Completion Date : | April 30, 2024 |
Estimated Study Completion Date : | July 31, 2025 |

Group/Cohort | Intervention/treatment |
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General Population
The general population will have their microbiome sequenced from stool samples provided.
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Other: There is no intervention in this study
There is no intervention in this study |
- 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.
- Validation of Sequencing Methods [ Time Frame: One year ]To validate the methods used to sequence samples
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359836
Contact: Sabine Hazan, MD | 805-339-0549 | drsabinehazan@progenabiome.com | |
Contact: Jordan Daniels, MS | 217-494-6692 | jordan@progenabiome.com |
United States, California | |
ProgenaBiome | Recruiting |
Ventura, California, United States, 93003 | |
Contact: Sabine Hazan, MD 805-339-0549 drsabinehazan@progenabiome.com | |
Contact: Jordan Daniels, MS 805-339-0549 jordan@progenabiome.com | |
Principal Investigator: Sabine Hazan, MD |
Principal Investigator: | Sabine Hazan, MD | ProgenaBiome |
Responsible Party: | ProgenaBiome |
ClinicalTrials.gov Identifier: | NCT04359836 |
Other Study ID Numbers: |
PRG-041 |
First Posted: | April 24, 2020 Key Record Dates |
Last Update Posted: | September 5, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Microbiome Coronavirus Corona Virus |
19 COVID COVID-19 |
COVID-19 Infections Communicable Diseases Coronavirus Infections Coronaviridae Infections Disease Attributes Pathologic Processes Respiratory Tract Infections |
Pneumonia, Viral Pneumonia Virus Diseases Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |