Trial Outcomes & Findings for The Role of Resistant Starch in COVID-19 Infection (NCT NCT04342689)
NCT ID: NCT04342689
Last Updated: 2022-10-05
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
226 participants
Primary outcome timeframe
One month from the start of treatment
Results posted on
2022-10-05
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
113
|
|
Overall Study
COMPLETED
|
71
|
68
|
|
Overall Study
NOT COMPLETED
|
42
|
45
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
32
|
33
|
|
Overall Study
Lost to Follow-up
|
10
|
12
|
Baseline Characteristics
The Role of Resistant Starch in COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Resistant Starch Supplement
n=113 Participants
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)
|
Total
n=226 Participants
Total of all reporting groups
|
Placebo Supplement
n=113 Participants
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)
|
|---|---|---|---|
|
Age, Continuous
|
45 years
n=7 Participants
|
45 years
n=5 Participants
|
45 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
94 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
113 participants
n=7 Participants
|
226 participants
n=5 Participants
|
113 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month from the start of treatmentPopulation: Intention to treat
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.
Outcome measures
| Measure |
Control
n=113 Participants
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)
|
Intervention
n=113 Participants
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)
|
|---|---|---|
|
Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3)
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: One month from the start of treatment, up to 4 monthsPopulation: Intention to treat
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.
Outcome measures
| Measure |
Control
n=113 Participants
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)
|
Intervention
n=113 Participants
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)
|
|---|---|---|
|
Time to Clinical Recovery (TTCR) (Phase 2)
|
12 days
Interval 0.0 to 42.0
|
8 days
Interval 0.0 to 42.0
|
SECONDARY outcome
Timeframe: One month from the start of treatment, up to 4 monthsThis 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.
Outcome measures
| Measure |
Control
n=113 Participants
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)
|
Intervention
n=113 Participants
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)
|
|---|---|---|
|
Peak Symptom Severity Score (Phase 2)
|
6 score on a scale
Interval 0.0 to 16.0
|
5 score on a scale
Interval 0.0 to 17.0
|
Adverse Events
Placebo Supplement
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Resistant Starch Supplement
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Supplement
n=113 participants at risk
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)
|
Resistant Starch Supplement
n=113 participants at risk
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)
|
|---|---|---|
|
Gastrointestinal disorders
Gas
|
21.2%
24/113 • Up to 1 month after completion of treatment course
|
31.0%
35/113 • Up to 1 month after completion of treatment course
|
Additional Information
Sherry Mansour, MD, MS Assistant Professor
Yale School of Medicine
Phone: (203) 785-4184
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place