COVID-19
Conditions
Keywords
COVID-19, Resistant Starch, Inflammation
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.
Interventions
DRUGDietary 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)
DIETARY_SUPPLEMENTPlacebo 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)
Sponsors
University of Michigan
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinical Recovery (TTCR) (Phase 2) | 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. |
| Peak Symptom Severity Score (Phase 2) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Supplement 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.
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) | 113 |
| Resistant Starch Supplement 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.
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) | 113 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 12 |
| Overall Study | Withdrawal by Subject | 32 | 33 |
Baseline characteristics
| Characteristic | Placebo Supplement | Resistant Starch Supplement | Total |
|---|---|---|---|
| Age, Continuous | 45 years | 45 years | 45 years |
| Race/Ethnicity, Customized Black | 92 Participants | 94 Participants | 186 Participants |
| Race/Ethnicity, Customized Unknown | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 13 Participants | 28 Participants |
| Region of Enrollment United States | 113 participants | 113 participants | 226 participants |
| Sex: Female, Male Female | 65 Participants | 70 Participants | 135 Participants |
| Sex: Female, Male Male | 48 Participants | 43 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 113 |
| other Total, other adverse events | 24 / 113 | 35 / 113 |
| serious Total, serious adverse events | 0 / 113 | 0 / 113 |
Outcome results
Primary
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.
Time frame: One month from the start of treatment
Population: Intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3) | 2 Participants |
| Intervention | Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3) | 2 Participants |
p-value: 0.99Chi-squared
Secondary
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.
Time frame: One month from the start of treatment, up to 4 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Peak Symptom Severity Score (Phase 2) | 6 score on a scale |
| Intervention | Peak Symptom Severity Score (Phase 2) | 5 score on a scale |
p-value: 0.24t-test, 2 sided
Secondary
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.
Time frame: One month from the start of treatment, up to 4 months
Population: Intention to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Time to Clinical Recovery (TTCR) (Phase 2) | 12 days |
| Intervention | Time to Clinical Recovery (TTCR) (Phase 2) | 8 days |
p-value: 0.52t-test, 2 sided