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.
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.
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)
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)
Other Name: Non Resistant Starch
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
Yale University
New Haven, Connecticut, 06510
Investigator: Sherry Mansour
Contact: 203-737-2676
University of Michigan
Ann Arbor, Michigan, 48109
Investigator: Mary Riwes
Contact: 734-936-9814
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