Official Title
The Role of Resistant Starch in COVID-19 Infection
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 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.

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 severity of the COVID-19 infection and preventing hospitalization is

critical. Patients suffering from COVID-19 have been shown to have a significant inflammatory

response resembling that of cytokine release syndrome, and it is this inflammatory phase that

is thought to drive fatality.



To this end, a multi-center randomized clinical trial to determine the efficacy of resistant

starch in reducing the need for hospitalization for COVID-19 positive patients will be

studied. This study will enroll 1500 non-hospitalized COVID-19 positive individuals who are

being monitored in the outpatient setting. Patients will be randomized to either a dietary

supplement containing resistant starch or a placebo for 14 days. Our primary outcome is the

rate of hospitalization for COVID-19 related complications. Secondary outcomes will look at

time to recovery and symptom severity scores.

Recruiting
COVID-19

Drug: Dietary Supplement containing resistant starch
Two tablespoons (

20 grams) to be taken twice daily for 14 days (start with 2 tablespoons once daily for three days, followed by twice daily on days 4 through 14)
Intervention
Other Name: Resistant Starch

Dietary Supplement: Placebo Starch
Two tablespoons (

20 grams) to be taken twice daily for 14 days (start with 2 tablespoons once daily for three days, followed by twice daily on days 4 through 14)
Control
Other Name: Non Resistant Starch

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 19 Years
Countries
United States
Locations

Yale University
New Haven, Connecticut, 06510

Recruiting

Investigator: Sherry Mansour
Contact: 203-737-2676
sherry.mansour@yale.edu

University of Michigan
Ann Arbor, Michigan, 48109

Recruiting

Investigator: Mary Riwes
Contact: 734-936-9814
mmriwes@med.umich.edu

Contacts

Sherry G Mansour, MD, MS
203-737-2676
sherry.mansour@yale.edu

Mary M Riwes, DO
734-936-8785
mmriwes@med.umich.edu

Sherry Mansour, MD, MS
Principal Investigator
Yale University

Yale University
University of Michigan
NCT Number
Keywords
Covid-19
Resistant Starch
inflammation
MeSH Terms
Infection