Clinical trial NCT04342689: The Role of Resistant Starch in COVID-19 Infection
Official title: The Role of Resistant Starch in COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: COVID-19
Resistant Starch
Inflammation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2020-04-13
Enrollment: 226
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3)
timeFrame: One month from the start of treatment
Secondary outcomes:
measure: Time to Clinical Recovery (TTCR) (Phase 2)
timeFrame: One month from the start of treatment, up to 4 months
measure: Peak Symptom Severity Score (Phase 2)
timeFrame: One month from the start of treatment, up to 4 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Yale University
name: Sherry Mansour, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: