The Role of Resistant Starch in COVID-19 Infection

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multicenter randomized trial to evaluate the efficacy of administering a dietary supplement containing resistant starch to non-hospitalized COVID-19 positive subjects, The intervention will begin as soon as possible after subjects test positive for COVID-19 and continue for 14 days. Investigators hypothesize that short-term administration of a dietary supplement containing resistant starch has the potential to reduce rates of hospitalization and improve time to clinical recovery and symptoms in non-hospitalized COVID-19 positive patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: University of Michigan; University of Minnesota

Criteria

Inclusion Criteria:

• greater than 18 years of age

• COVID-positive status

• Being monitored in an outpatient setting at one of our study sites:

• Yale New Haven Hospital (YNHH)

• University of Michigan

• University of Minnesota

Exclusion Criteria:

• inflammatory bowel disease

• history of gastric bypass surgery

• active Clostridium difficile infection

• active participation in another COVID-19 interventional trial

• any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with the protocol procedures.

• Reported allergy to starch

• Difficulty swallowing in order to prevent any aspiration risk

• Currently taking any IL-6 inhibitors such as Tocilizumab for any disease condition