The Role of Resistant Starch in COVID-19 Infection

NCT04342689 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2000027887
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

COVID-19; Resistant Starch; Inflammation

Outcome Measures

Primary Outcomes (1)

• Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3)

  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 Outcomes (2)

• Time to Clinical Recovery (TTCR) (Phase 2)

  One month from the start of treatment, up to 4 months

• Peak Symptom Severity Score (Phase 2)

  One month from the start of treatment, up to 4 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Dietary Supplement containing resistant starch DRUG

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)

Also known as: Resistant Starch

Intervention

Placebo Starch DIETARY_SUPPLEMENT

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)

Also known as: Non Resistant Starch

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• University of Michigan: collaborator

Study Sites (2)

Yale University

New Haven, Connecticut, 06510, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

COVID-19; Inflammation

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Sherry Mansour, MD, MS Assistant Professor
• Organization: Yale School of Medicine

sherry.mansour@yale.edu

(203) 785-4184

Study Officials

• Sherry Mansour, MD, MS

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: June 3, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: October 5, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication, indefinitely

Locations

US (2)