The Role of Resistant Starch in COVID-19 Infection

September 27, 2022 updated by: Sherry Mansour, Yale University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
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.
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 Names:
  • Resistant Starch
PLACEBO_COMPARATOR: Control
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.
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 Names:
  • Non Resistant Starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3)
Time Frame: One month from the start of treatment
Hospitalization for a COVID-19 related admission during the first month of follow up. Death prior to hospitalization thought to be secondary to COVID-19 will also be defined as an event.
One month from the start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clinical Recovery (TTCR) (Phase 2)
Time Frame: One month from the start of treatment, up to 4 months
Time to clinical recovery will be defined by a return to normal body temperature (97-99 degrees F) as reported by the patient, and resolution of major presenting symptoms (myalgia, cough, shortness of breath, and GI symptoms) maintained for 72 hours. Patients will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via a pre-specified questionnaire. Patients will be followed from the start of treatment to the end of follow-up at 4 months.
One month from the start of treatment, up to 4 months
Peak Symptom Severity Score (Phase 2)
Time Frame: One month from the start of treatment, up to 4 months
This score will be evaluated using a subjective self-reporting questionnaire around 8 symptoms, which include: shortness of breath at rest or exertion, fatigue, myalgia/muscle aces, fever, cough, headache, GI symptoms, inability to taste or smell. Subjects will rate each of their symptoms on an ordinal scale as follows: absent (0), mild (1), moderate (2), or severe (3). These symptom ratings will be added to define the symptom severity score with a possible score range of 0-24 points. Subjects will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via this pre-specified questionnaire. Patients will be followed from the start of treatment to the end of follow-up at 4 months. "Peak" was added to the outcome title (to correctly identify the measure) when results were entered.
One month from the start of treatment, up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

University of Michigan

Investigators

  • Principal Investigator: Sherry Mansour, MD, MS, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 3, 2020

Primary Completion (ACTUAL)

April 15, 2021

Study Completion (ACTUAL)

April 15, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (ACTUAL)

April 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000027887

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data underlying results for publication are planned to be made available after publication.

IPD Sharing Time Frame

After publication, indefinitely

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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