Status:
TERMINATED
The Role of Resistant Starch in COVID-19 Infection
Lead Sponsor:
Yale University
Collaborating Sponsors:
University of Michigan
Conditions:
COVID-19
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
The COVID-19 pandemic has caused a substantial strain on the healthcare system, with at least 14% of infected patients requiring hospitalization. Identifying ways to ameliorate the progression and sev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT04342689
Start Date
June 3 2020
End Date
April 15 2021
Last Update
October 5 2022
Active Locations (2)
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1
Yale University
New Haven, Connecticut, United States, 06510
2
University of Michigan
Ann Arbor, Michigan, United States, 48109