COVID-19Phase 2/3NCT04342689
The Role of Resistant Starch in COVID-19 Infection
A Phase 2/3 study testing Dietary Supplement containing resistant starch in people with COVID-19, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Dietary Supplement containing resistant starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2020to 15 Apr 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Yale University
New Haven, Connecticut, 06510
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Dietary Supplement containing resistant starch, Placebo Starch
- Keywords
- COVID-19, Resistant Starch, Inflammation
- Medical subject headings
- COVID-19, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement containing resistant starchDrug
Also called 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)
Placebo StarchDietary supplement
Also called Non 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month from the start of treatment
Secondary outcomes (2)
Time to Clinical Recovery (TTCR) (Phase 2)
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.
Measured: One month from the start of treatment, up to 4 months
Peak Symptom Severity Score (Phase 2)
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.
Measured: One month from the start of treatment, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start3 Jun 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Why it stopped: Study was terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Sherry Mansour, Yale University
- Investigators
- Sherry Mansour, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342689
- Sponsor's protocol ID
- 2000027887
- Status last verified
- Sep 2022
- First submitted
- 8 Apr 2020
- Last updated
- 5 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data underlying results for publication are planned to be made available after publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Resistant Starch in COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04342689
- Acronym / sponsor ID
- 2000027887
- Conditions
- COVID-19
- Keywords
- COVID-19, Resistant Starch, Inflammation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to low enrollment.
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Posted 5 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Dietary Supplement containing resistant starchSubjects 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. |
| Control | Placebo comparator | Dietary Supplement: Placebo StarchSubjects 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement containing resistant starchAlso: Resistant StarchTwo 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) | Drug | Intervention |
| Placebo StarchAlso: Non Resistant StarchTwo 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) | Dietary supplement | Control |
Primary outcome
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.
2 secondary outcomes
Time to Clinical Recovery (TTCR) (Phase 2)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data underlying results for publication are planned to be made available after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry Mansour, MD, MS principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dietary Supplement containing resistant starch in people with COVID-19, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3) (time frame: One month from the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.