Trial Outcomes & Findings for DISulfiram for COvid-19 (DISCO) Trial (NCT NCT04485130)
NCT ID: NCT04485130
Last Updated: 2023-09-13
Results Overview
Change in plasma inflammatory biomarker levels (e.g., IL-6, IL-1b) at days 5, 15, and 31.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Day 0 and Day 31
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Disulfiram 1000 mg
Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 1: Placebo
This study will provide placebo comparator for disulfiram. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Disulfiram 2000 mg
Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Placebo
Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
0
|
0
|
|
Overall Study
COMPLETED
|
7
|
4
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DISulfiram for COvid-19 (DISCO) Trial
Baseline characteristics by cohort
| Measure |
Cohort 1: Disulfiram 1000 mg
n=7 Participants
This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 1: Placebo
n=4 Participants
This study will provide placebo comparator for disulfiram. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Disulfiram 2000 mg
Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Placebo
Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
43.5 years
STANDARD_DEVIATION 8 • n=107 Participants
|
—
|
—
|
40 years
STANDARD_DEVIATION 11 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
—
|
—
|
7 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
—
|
—
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
—
|
—
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
—
|
—
|
7 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
—
|
—
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
—
|
—
|
11 participants
n=31 Participants
|
|
BMI
|
25.6 kg/m^2
STANDARD_DEVIATION 5.5 • n=99 Participants
|
33.3 kg/m^2
STANDARD_DEVIATION 2.2 • n=107 Participants
|
—
|
—
|
28.4 kg/m^2
STANDARD_DEVIATION 5.9 • n=31 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 31Population: The trial stopped early so we were unable to enroll for Cohort 2.
Change in plasma inflammatory biomarker levels (e.g., IL-6, IL-1b) at days 5, 15, and 31.
Outcome measures
| Measure |
Cohort 1: Disulfiram 100 mg
n=7 Participants
This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 1: Placebo
n=4 Participants
This study will provide placebo comparator for disulfiram. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Disulfiram 2000 mg
Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Placebo
Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
|---|---|---|---|---|
|
Immunologic Impact of 5 Days of Disulfiram, as Measured by the Fold-change in Plasma Levels of Pro-inflammatory Cytokines (e.g, Interleukin 6, Interleukin 1-beta, Etc.).
Change in IL-6 (pg/mL) Day 0 to 31
|
-0.1186 fold change
Interval -0.2012 to -0.0246
|
-0.0215 fold change
Interval -0.1202 to -0.0178
|
—
|
—
|
|
Immunologic Impact of 5 Days of Disulfiram, as Measured by the Fold-change in Plasma Levels of Pro-inflammatory Cytokines (e.g, Interleukin 6, Interleukin 1-beta, Etc.).
Change in IL-1B (pg/mL) Day 0 to 31
|
-0.1402 fold change
Interval -0.2583 to 0.0648
|
0.0268 fold change
Interval -0.0438 to 0.0399
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 31Population: The trial stopped early so we were unable to enroll for Cohort 2.
Change in copies of SARS-CoV-2 PCR virus per mL between Baseline and Day 31.
Outcome measures
| Measure |
Cohort 1: Disulfiram 100 mg
n=7 Participants
This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 1: Placebo
n=4 Participants
This study will provide placebo comparator for disulfiram. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Disulfiram 2000 mg
Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Placebo
Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
|---|---|---|---|---|
|
Virologic Impact of 5 Days of Disulfiram, as Measured by the Change in Copies of SARS-CoV-2 Virus Per mL Between Baseline and Day 31.
|
-20.89 copies/mL
Standard Deviation 9.84
|
-20 copies/mL
Standard Deviation 13.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 31Population: The trial stopped early so we were unable to enroll for Cohort 2.
The safety and tolerability of a 5 day course of disulfiram. The number of adverse events and their grade will be determined for each participant.
Outcome measures
| Measure |
Cohort 1: Disulfiram 100 mg
n=7 Participants
This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 1: Placebo
n=4 Participants
This study will provide placebo comparator for disulfiram. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Disulfiram 2000 mg
Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Placebo
Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
AE Grade 3 or Higher
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
AE Grade 1 or 2
|
4 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 31Population: The trial stopped early so we were unable to enroll for Cohort 2.
The severity of COVID-19 symptoms will be recorded on a 5-point symptom severity scale at each visit for each participant. A question about how much the symptoms bother the participants will be asked. The participant will rank 1 as "not at all," 2 as "a little bit," 3 as "somewhat," 4 as "quite a bit" and 5 as "very much." Higher values represent worse outcomes. Scales are combined to compute a total score at Day 0 and Day 31. A change of the median is reported.
Outcome measures
| Measure |
Cohort 1: Disulfiram 100 mg
n=7 Participants
This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 1: Placebo
n=4 Participants
This study will provide placebo comparator for disulfiram. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Disulfiram 2000 mg
Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Placebo
Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
|---|---|---|---|---|
|
Change in COVID-19 Symptom Severity Score as Assessed by a 5-point Adapted Somatic Symptom Severity Score (SSS-8)
|
-2.60 units on a scale
Interval -3.0 to 0.35
|
-2.14 units on a scale
Interval -3.37 to -0.59
|
—
|
—
|
Adverse Events
Cohort 1: Disulfiram
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Disulfiram
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Disulfiram
n=7 participants at risk
This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 1: Placebo
n=4 participants at risk
This study will provide placebo comparator for disulfiram. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Disulfiram
Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Placebo
Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/7 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
25.0%
1/4 • Number of events 1 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
Other adverse events
| Measure |
Cohort 1: Disulfiram
n=7 participants at risk
This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 1: Placebo
n=4 participants at risk
This study will provide placebo comparator for disulfiram. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Disulfiram
Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
Cohort 2: Placebo
Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Dehydration
|
14.3%
1/7 • Number of events 1 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
0.00%
0/4 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
|
Gastrointestinal disorders
Black stool and post viral cough syndrome
|
0.00%
0/7 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
25.0%
1/4 • Number of events 1 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
|
General disorders
GI (nausea/vomiting), fever, chills, congestion, sore throat, back pain, muscle ache, headache
|
14.3%
1/7 • Number of events 1 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
0.00%
0/4 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
|
General disorders
Smell and taste
|
14.3%
1/7 • Number of events 1 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
0.00%
0/4 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
|
General disorders
Smell/taste, gas, back pain
|
14.3%
1/7 • Number of events 1 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
0.00%
0/4 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
—
0/0 • The total duration of the study was approximately 6 months from August 18, 2021 to February 28, 2022. Each participant was assessed for 31 days during the duration of their enrollment in the study. There was one serious adverse event that lasted 5 days from September 6, 2021 to September 11, 2021.
Systematic assessment through detailed questionnaires and principal investigator physical exam assessment was conducted at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place