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

P

ProgenaBiome

Status

Enrolling

Conditions

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

Treatments

Other: There is no intervention in this study

Study type

Observational

Funder types

Other

Identifiers

NCT04359836
PRG-041

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

250 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Sabine Hazan, MD; Jordan Daniels, MS

Data sourced from clinicaltrials.gov

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