The Role of Resistant Starch in COVID-19 Infection

Yale University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: Dietary Supplement containing resistant starch; Dietary Supplement: Placebo Starch

Study type: Interventional

Funder types: Other

Identifiers

NCT04342689

2000027887

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Subjects will receive a dietary supplement containing resistant starch and be instructed to take 2 tablespoons (\~20 grams) twice daily for 14 days. Initially subjects will take 2 tablespoons once daily for the first three days prior to increasing to 2 tablespoons twice daily.

Treatment:

Drug: Dietary Supplement containing resistant starch

Control

Placebo Comparator group

Description:

Subjects will receive a placebo starch, consisting of non resistant starch and be instructed to take 2 tablespoons (\~ 20 grams) twice daily for 14 days. Initially subjects will take 2 tablespoons once daily for the first three days.

Treatment:

Dietary Supplement: Placebo Starch