The Role of Resistant Starch in COVID-19 Infection

• ClinicalTrials.gov Identifier: NCT04342689
• Recruitment Status: Recruiting
• First Posted: April 13, 2020
• Last Update Posted: January 26, 2021
• Sponsor: Yale University
• Collaborator: University of Michigan
• Information provided by (Responsible Party): Sherry Mansour, Yale University

Tracking Information

• First Submitted Date: April 8, 2020
• First Posted Date: April 13, 2020
• Last Update Posted Date: January 26, 2021
• Actual Study Start Date: June 3, 2020
• Estimated Primary Completion Date: June 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 21, 2021)

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.

Original Primary Outcome Measures (submitted: April 8, 2020)

Rates of hospitalization for a COVID-19 related complication [ Time Frame: One month from the start of treatment ]

Subject hospitalized while presenting symptoms of fever, shortness of breath, myalgia, cough, or hypoxia with an admission diagnosis of hypoxic respiratory failure, pneumonia, or vial pneumonia on review of electronic health record (EHR). Death prior to hospitalization thought to be secondary to COVID-19 will also be defined as an event. All hospital admissions will be reviewed and adjudicated by a site PI.

Current Secondary Outcome Measures (submitted: January 21, 2021)

• 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.
• 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.

Original Secondary Outcome Measures (submitted: April 8, 2020)

• Time to clinical recovery (TTCR) [ 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 via EHR review.
• Symptom Severity Score [ Time Frame: One month from the start of treatment ]
  This score will be evaluated used in a subjective self-reporting questionniare 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Role of Resistant Starch in COVID-19 Infection
• Official Title: The Role of Resistant Starch in COVID-19 Infection
• 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.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: COVID-19

Intervention

• 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

Study Arms

• 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.
  Intervention: Drug: Dietary Supplement containing 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.
  Intervention: Dietary Supplement: Placebo Starch

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 22, 2020): 1500
• Original Estimated Enrollment (submitted: April 8, 2020): 1300
• Estimated Study Completion Date: June 1, 2021
• Estimated Primary Completion Date: June 1, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04342689
• Other Study ID Numbers: 2000027887
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: After publication, indefinitely

• Responsible Party: Sherry Mansour, Yale University
• Study Sponsor: Yale University
• Collaborators: University of Michigan

Investigators

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

• PRS Account: Yale University
• Verification Date: January 2021