Trial Outcomes & Findings for ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivermectin 400) (NCT NCT05736861)
NCT ID: NCT05736861
Last Updated: 2023-06-13
Results Overview
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1800 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2023-06-13
Participant Flow
Participant milestones
| Measure |
Arm A - Ivermectin 400
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Overall Study
STARTED
|
919
|
881
|
|
Overall Study
COMPLETED
|
817
|
774
|
|
Overall Study
NOT COMPLETED
|
102
|
107
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivermectin 400)
Baseline characteristics by cohort
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
Total
n=1591 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
n=99 Participants
|
48 years
n=107 Participants
|
47 years
n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
508 Participants
n=99 Participants
|
424 Participants
n=107 Participants
|
932 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
309 Participants
n=99 Participants
|
349 Participants
n=107 Participants
|
658 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Prefer Not to Answer
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
93 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
724 Participants
n=99 Participants
|
704 Participants
n=107 Participants
|
1428 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black, African American, or African
|
50 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern or North African
|
29 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
643 Participants
n=99 Participants
|
619 Participants
n=107 Participants
|
1262 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
19 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
None of the above
|
25 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
14 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
No response
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
817 Participants
n=99 Participants
|
774 Participants
n=107 Participants
|
1591 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysTime to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Time to Sustained Recovery in Days
|
12 days
Interval 11.0 to 13.0
|
13 days
Interval 12.0 to 14.0
|
SECONDARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants With Hospitalization or Death
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants With Mortality
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysTime to mortality was the number of days between drug receipt and death.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Time to Mortality
|
NA days
Per the protocol/SAP, this endpoint is only analyzed if the number of total events exceeds 30. Due to the low event rate, the statistical analysis was not completed.
|
NA days
Per the protocol/SAP, this endpoint is only analyzed if the number of total events exceeds 30. Due to the low event rate, the statistical analysis was not completed.
|
SECONDARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
|
32 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: Data not collected on 9 participants.
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=813 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=769 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
0 = No clinical or virological evidence of infection
|
45 Participants
|
51 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
1 = No limitation of activities
|
708 Participants
|
646 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
2 = Limitation of activities
|
53 Participants
|
68 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
1 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
4 = Hospitalized, on oxygen by mask or nasal prongs
|
5 Participants
|
2 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
5 = Hospitalized, on non-invasive ventilation or high-flow oxygen
|
0 Participants
|
1 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
6 = Hospitalized, on intubation and mechanical ventilation
|
1 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
8 = Death
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: Data not collected on 21 participants.
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=805 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=765 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
0 = No clinical or virological evidence of infection
|
52 Participants
|
60 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
1 = No limitation of activities
|
722 Participants
|
664 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
2 = Limitation of activities
|
28 Participants
|
38 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
1 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
4 = Hospitalized, on oxygen by mask or nasal prongs
|
0 Participants
|
1 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
5 = Hospitalized, on non-invasive ventilation or high-flow oxygen
|
1 Participants
|
1 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
6 = Hospitalized, on intubation and mechanical ventilation
|
1 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
8 = Death
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Data not collected on 36 participants.
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=795 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=760 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
0 = No clinical or virological evidence of infection
|
56 Participants
|
59 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
1 = No limitation of activities
|
718 Participants
|
682 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
2 = Limitation of activities
|
19 Participants
|
18 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
1 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
4 = Hospitalized, on oxygen by mask or nasal prongs
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
5 = Hospitalized, on non-invasive ventilation or high-flow oxygen
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
6 = Hospitalized, on intubation and mechanical ventilation
|
1 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
8 = Death
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 7
|
19 score on a scale
Interval 16.0 to 20.0
|
19 score on a scale
Interval 16.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 14
|
20 score on a scale
Interval 18.0 to 20.0
|
20 score on a scale
Interval 18.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 28
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 90
|
20 score on a scale
Interval 20.0 to 20.0
|
20 score on a scale
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 7
|
9 score on a scale
Interval 7.0 to 13.0
|
9 score on a scale
Interval 7.0 to 13.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 14
|
7 score on a scale
Interval 4.0 to 9.0
|
7 score on a scale
Interval 4.0 to 9.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 28
|
5 score on a scale
Interval 4.0 to 8.0
|
5 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Day 90
|
4 score on a scale
Interval 4.0 to 8.0
|
4 score on a scale
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 7
|
5 score on a scale
Interval 4.0 to 9.0
|
5 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 14
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 7.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 28
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 90
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 7
|
4 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 4.0 to 6.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 14
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 28
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Day 90
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 7
|
5 score on a scale
Interval 4.0 to 8.0
|
5 score on a scale
Interval 4.0 to 8.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 14
|
4 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 4.0 to 6.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 28
|
4 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 90
|
4 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 7
|
17 score on a scale
Interval 13.0 to 20.0
|
17 score on a scale
Interval 13.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 14
|
20 score on a scale
Interval 16.0 to 20.0
|
20 score on a scale
Interval 16.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 28
|
20 score on a scale
Interval 17.0 to 20.0
|
20 score on a scale
Interval 17.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Day 90
|
20 score on a scale
Interval 17.25 to 20.0
|
20 score on a scale
Interval 18.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, and 90Population: Participants who responded to the quality of life survey at each timepoint.
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep Domain
Day 7
|
10 score on a scale
Interval 8.0 to 12.0
|
10 score on a scale
Interval 7.0 to 12.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep Domain
Day 14
|
9 score on a scale
Interval 6.0 to 12.0
|
9 score on a scale
Interval 6.0 to 11.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep Domain
Day 28
|
8 score on a scale
Interval 6.0 to 11.0
|
9 score on a scale
Interval 6.0 to 11.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep Domain
Day 90
|
8 score on a scale
Interval 6.0 to 11.0
|
8 score on a scale
Interval 6.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to 14 daysThe symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
|
10.96 days
Interval 10.78 to 11.15
|
11.45 days
Interval 11.28 to 11.6
|
SECONDARY outcome
Timeframe: Up to 14 daysThe symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.
Outcome measures
| Measure |
Arm A - Ivermectin 400
n=817 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
|
3.91 days
Interval 3.69 to 4.13
|
3.31 days
Interval 3.11 to 3.51
|
Adverse Events
Arm A - Ivermectin 400
Serious events: 13 serious events
Other events: 16 other events
Deaths: 1 deaths
Arm A - Placebo
Serious events: 17 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Ivermectin 400
n=817 participants at risk
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 participants at risk
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.37%
3/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.52%
4/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
COVID-19 pneumonia aggravated
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.39%
3/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
Bacteremia, with signs and symptoms
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
Pneumonia due to Staphylococcus
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
Pneumonia due to Streptococcus, group b
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.39%
3/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Viral bronchopneumonia
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Vascular disorders
Venous thromboembolism
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.26%
2/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Eye disorders
Diplopia
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Hepatobiliary disorders
Acute Cholecystitis
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Vascular disorders
Coronary vasospasm
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
COVID-19 pneumonia worsening
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
Death due to COVID-19
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Eye disorders
Opthalmic migraine
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
Pneumonia due to COVID-19 virus
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Vascular disorders
Upper GI bleed
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
Worsening of covid-19 pneumonia
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
Other adverse events
| Measure |
Arm A - Ivermectin 400
n=817 participants at risk
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
|
Arm A - Placebo
n=774 participants at risk
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Accelerated hair loss
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Investigations
Blood pressure raised
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
General disorders
Chest tightness
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Nervous system disorders
Confusion
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Nervous system disorders
Dizziness
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Cardiac disorders
Dyspnea
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Gastrointestinal disorders
Heartburn
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Metabolism and nutrition disorders
Hepatic steatosis
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial pneumonia
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Nervous system disorders
Migraine with aura
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Gastrointestinal disorders
Nausea
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Gastrointestinal disorders
Nausea and emesis
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Immune system disorders
Seasonal Allergies
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Injury, poisoning and procedural complications
Shoulder dislocation
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Cardiac disorders
Sinus bradycardia
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.00%
0/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
Sinus infection
|
0.12%
1/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Infections and infestations
Suspected Covid-19
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
General disorders
Tiredness
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/817 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
0.13%
1/774 • Up to 90 days
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place