Trial Outcomes & Findings for Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19 (NCT NCT04400890)
NCT ID: NCT04400890
Last Updated: 2023-02-24
Results Overview
Number of study participants admitted to the hospital within 21 days of randomization
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
21 days from study randomization
Results posted on
2023-02-24
Participant Flow
Between September 13, 2020 and December 11, 2020, 1,694 patients were telephoned within 24-h of testing positive for COVID-19 to be recruited into the clinical trial . One-hundred-five were enrolled and randomized. Five withdrew after receiving treatment packets (four withdrew before starting treatment and one withdrew after one treatment day citing "too many pills" as reason for withdrawal).
One-hundred-five subjects were enrolled and randomized. Four participants withdrew before starting treatment. One participant withdrew after one treatment day citing "too many pills" as reason for withdrawal.
Participant milestones
| Measure |
Resveratrol With Vitamin D3
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
Treated Per Protocol Population
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Resveratrol With Vitamin D3
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19
Baseline characteristics by cohort
| Measure |
Resveratrol With Vitamin D3
n=53 Participants
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
n=52 Participants
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 9.46 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
BMI
|
29.1 kg/m^2
STANDARD_DEVIATION 4.68 • n=5 Participants
|
31.4 kg/m^2
STANDARD_DEVIATION 7.32 • n=7 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
High Risk Comorbidity= YES
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
High Risk Comorbidity= NO
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Chronic Lung Disease
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Diabetes Mellitus
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Cardiovascular Disease
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Renal Disease
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Liver Disease
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Immunocompromised
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Current Smoker
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Former Smoker
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Angiotensin Converting Enzyme Inhibitor (ACEI) / Angiotensin Receptor Blocker (ARB) use
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Vitamin D use
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Oral Steroid Use
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Inhaled Steroid Use
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days from study randomizationNumber of study participants admitted to the hospital within 21 days of randomization
Outcome measures
| Measure |
Resveratrol With Vitamin D3
n=50 Participants
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
n=50 Participants
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
Hospitalization Rates for COVID-19
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 21 days from randomizationNumber of study participants admitted within 21 who subsequently get admitted to the ICU
Outcome measures
| Measure |
Resveratrol With Vitamin D3
n=50 Participants
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
n=50 Participants
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
ICU Admission Rates
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 21 days from randomizationNumber of study participants who get admitted with 21 day of randomization who receiving invasive ventilation.
Outcome measures
| Measure |
Resveratrol With Vitamin D3
n=50 Participants
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
n=50 Participants
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
Invasive Ventilation Rates
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 21 days from randomizationNumber of study participants are diagnosed with pneumonia with 21 day of randomization
Outcome measures
| Measure |
Resveratrol With Vitamin D3
n=50 Participants
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
n=50 Participants
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
Pneumonia
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 21 days from start of randomization.Number of study participants are diagnosed with pulmonary embolism with 21 day of randomization
Outcome measures
| Measure |
Resveratrol With Vitamin D3
n=50 Participants
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
n=50 Participants
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
Pulmonary Embolism
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 21 days from randomizationNumber of study participants who died with 21 day of randomization
Outcome measures
| Measure |
Resveratrol With Vitamin D3
n=50 Participants
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
n=50 Participants
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
Death
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 days from randomizationDiarrhea, nausea, abdominal cramping
Outcome measures
Outcome data not reported
Adverse Events
Resveratrol With Vitamin D3
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo With Vitamin D3
Serious events: 8 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Resveratrol With Vitamin D3
n=50 participants at risk
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
n=50 participants at risk
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/50 • With 60 days of randomization
|
2.0%
1/50 • Number of events 1 • With 60 days of randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.0%
4/50 • Number of events 4 • With 60 days of randomization
|
16.0%
8/50 • Number of events 8 • With 60 days of randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.0%
1/50 • Number of events 1 • With 60 days of randomization
|
2.0%
1/50 • Number of events 1 • With 60 days of randomization
|
Other adverse events
| Measure |
Resveratrol With Vitamin D3
n=50 participants at risk
Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
Placebo With Vitamin D3
n=50 participants at risk
Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1
Vitamin D3: Vitamin D3 100,000 IU given on day one.
|
|---|---|---|
|
Gastrointestinal disorders
Increased Flatulence
|
40.0%
20/50 • With 60 days of randomization
|
32.0%
16/50 • With 60 days of randomization
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
6/50 • With 60 days of randomization
|
10.0%
5/50 • With 60 days of randomization
|
|
Skin and subcutaneous tissue disorders
Hives
|
10.0%
5/50 • With 60 days of randomization
|
4.0%
2/50 • With 60 days of randomization
|
|
Skin and subcutaneous tissue disorders
Bruises easily
|
6.0%
3/50 • With 60 days of randomization
|
10.0%
5/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Dry mouth
|
56.0%
28/50 • With 60 days of randomization
|
42.0%
21/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Sore Throat / Mount
|
36.0%
18/50 • With 60 days of randomization
|
34.0%
17/50 • With 60 days of randomization
|
|
Respiratory, thoracic and mediastinal disorders
Hoarse Voice
|
38.0%
19/50 • With 60 days of randomization
|
40.0%
20/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Problems Tasting / Smelling
|
60.0%
30/50 • With 60 days of randomization
|
48.0%
24/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Decreased Appetitis
|
58.0%
29/50 • With 60 days of randomization
|
52.0%
26/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Nausea
|
48.0%
24/50 • With 60 days of randomization
|
34.0%
17/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • With 60 days of randomization
|
6.0%
3/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Heartburn
|
38.0%
19/50 • With 60 days of randomization
|
28.0%
14/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Bloating
|
54.0%
27/50 • With 60 days of randomization
|
38.0%
19/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Diarrhea
|
54.0%
27/50 • With 60 days of randomization
|
38.0%
19/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Constipation
|
28.0%
14/50 • With 60 days of randomization
|
28.0%
14/50 • With 60 days of randomization
|
|
Gastrointestinal disorders
Pain in Abdomen
|
38.0%
19/50 • With 60 days of randomization
|
24.0%
12/50 • With 60 days of randomization
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
30/50 • With 60 days of randomization
|
62.0%
31/50 • With 60 days of randomization
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
26.0%
13/50 • With 60 days of randomization
|
16.0%
8/50 • With 60 days of randomization
|
|
Cardiac disorders
Racing Heartbeat
|
32.0%
16/50 • With 60 days of randomization
|
38.0%
19/50 • With 60 days of randomization
|
|
Skin and subcutaneous tissue disorders
Itchy Skin
|
18.0%
9/50 • With 60 days of randomization
|
20.0%
10/50 • With 60 days of randomization
|
|
Nervous system disorders
Dizziness
|
44.0%
22/50 • With 60 days of randomization
|
32.0%
16/50 • With 60 days of randomization
|
|
Eye disorders
Blurry Vision
|
22.0%
11/50 • With 60 days of randomization
|
20.0%
10/50 • With 60 days of randomization
|
|
Eye disorders
Redness or watery eyes
|
32.0%
16/50 • With 60 days of randomization
|
32.0%
16/50 • With 60 days of randomization
|
|
Nervous system disorders
Problems Concentrating
|
38.0%
19/50 • With 60 days of randomization
|
42.0%
21/50 • With 60 days of randomization
|
|
Nervous system disorders
Problems with memory
|
28.0%
14/50 • With 60 days of randomization
|
24.0%
12/50 • With 60 days of randomization
|
|
General disorders
Pain
|
52.0%
26/50 • With 60 days of randomization
|
44.0%
22/50 • With 60 days of randomization
|
|
Nervous system disorders
Headache
|
62.0%
31/50 • With 60 days of randomization
|
60.0%
30/50 • With 60 days of randomization
|
|
Musculoskeletal and connective tissue disorders
Aching Muscle
|
52.0%
26/50 • With 60 days of randomization
|
48.0%
24/50 • With 60 days of randomization
|
|
Musculoskeletal and connective tissue disorders
Aching Joint
|
40.0%
20/50 • With 60 days of randomization
|
40.0%
20/50 • With 60 days of randomization
|
|
Blood and lymphatic system disorders
Nosebleeds
|
10.0%
5/50 • With 60 days of randomization
|
4.0%
2/50 • With 60 days of randomization
|
|
General disorders
Shivering
|
24.0%
12/50 • With 60 days of randomization
|
28.0%
14/50 • With 60 days of randomization
|
Additional Information
Marvin McCreary, MD
formerly of Mount Carmel Health Systems
Phone: 614-526-8492
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place