A 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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
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
Primary Outcome Measures
- 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
- Validation of Sequencing Methods [One year]
To validate the methods used to sequence samples
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
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
Contacts and Locations
Sponsors and Collaborators
- Principal Investigator: Sabine Hazan, MD, ProgenaBiome
Study Documents (Full-Text)None provided.