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The Role of Resistant Starch in COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04342689
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Sherry Mansour, Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Dietary Supplement containing resistant starch Dietary Supplement: Placebo Starch Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Resistant Starch in COVID-19 Infection
Actual Study Start Date : June 3, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

Arms and Interventions
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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 Name: 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 Name: Non Resistant Starch


Outcome Measures
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Primary Outcome Measures :
  1. Rates of 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.


Secondary Outcome Measures :
  1. Time to clinical recovery (TTCR) (Phase 2) [ Time Frame: One month from the start of treatment ]
    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 continue to be followed for an additional 3 months by electronic medical record review.

  2. Symptom Severity Score (Phase 2) [ Time Frame: One month from the start of treatment ]
    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 continue to be followed for an additional 3 months via EHR review.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342689


Contacts
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Contact: Sherry G Mansour, MD, MS 203-737-2676 sherry.mansour@yale.edu
Contact: Mary M Riwes, DO 734-936-8785 mmriwes@med.umich.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Sherry Mansour    203-737-2676    sherry.mansour@yale.edu   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Mary Riwes    734-936-9814    mmriwes@med.umich.edu   
Sponsors and Collaborators
Yale University
University of Michigan
Investigators
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Principal Investigator: Sherry Mansour, MD, MS Yale University
More Information
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Responsible Party: Sherry Mansour, Instructor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT04342689    
Other Study ID Numbers: 2000027887
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data underlying results for publication are planned to be made available after publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After publication, indefinitely

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sherry Mansour, Yale University:
COVID-19
Resistant Starch
Inflammation
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases