Trial Outcomes & Findings for ACTIV-6: COVID-19 Study of Repurposed Medications - Arm D (Ivermectin 600) (NCT NCT05894538)
NCT ID: NCT05894538
Last Updated: 2023-11-03
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
1459 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2023-11-03
Participant Flow
Participant milestones
| Measure |
Arm D - Ivermectin 600
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
718
|
741
|
|
Overall Study
COMPLETED
|
708
|
724
|
|
Overall Study
NOT COMPLETED
|
10
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm D (Ivermectin 600)
Baseline characteristics by cohort
| Measure |
Arm D - Ivermectin 600
n=708 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=724 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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=1432 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
48 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
417 Participants
n=5 Participants
|
437 Participants
n=7 Participants
|
854 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
288 Participants
n=5 Participants
|
286 Participants
n=7 Participants
|
574 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Undifferentiated
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Prefer Not to Answer the Question
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
158 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
550 Participants
n=5 Participants
|
576 Participants
n=7 Participants
|
1126 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
50 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black, African American, or African
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Middle Eastern or North African
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
498 Participants
n=5 Participants
|
511 Participants
n=7 Participants
|
1009 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · None of the above
|
43 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Prefer not to answer
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
708 Participants
n=5 Participants
|
724 Participants
n=7 Participants
|
1432 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Data not collected on 46 participants.
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.
Outcome measures
| Measure |
Arm D - Ivermectin 600
n=686 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=700 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
11 days
Interval 11.0 to 12.0
|
12 days
Interval 11.0 to 12.0
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Data not collected on 2 participants.
Outcome measures
| Measure |
Arm D - Ivermectin 600
n=708 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=722 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Data not collected on 2 participants.
Outcome measures
| Measure |
Arm D - Ivermectin 600
n=708 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=722 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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 D - Ivermectin 600
n=708 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=724 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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 daysPopulation: Data not collected on 2 participants.
Outcome measures
| Measure |
Arm D - Ivermectin 600
n=708 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=722 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
39 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: Data not collected on 62 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 D - Ivermectin 600
n=677 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=693 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
8 = Death
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
0 = No clinical or virological evidence of infection
|
50 Participants
|
54 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
1 = No limitation of activities
|
582 Participants
|
600 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
2 = Limitation of activities
|
43 Participants
|
38 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
3 = Hospitalized, no oxygen therapy
|
1 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
|
1 Participants
|
0 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
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
6 = Hospitalized, on intubation and mechanical ventilation
|
0 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
|
SECONDARY outcome
Timeframe: Day 14Population: Data not collected on 73 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 D - Ivermectin 600
n=674 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=685 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
32 Participants
|
32 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
1 = No limitation of activities
|
616 Participants
|
637 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
2 = Limitation of activities
|
26 Participants
|
16 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
0 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
|
0 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
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
6 = Hospitalized, on intubation and mechanical ventilation
|
0 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
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Data not collected on 107 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 D - Ivermectin 600
n=661 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=664 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
12 Participants
|
19 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
1 = No limitation of activities
|
628 Participants
|
635 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
2 = Limitation of activities
|
20 Participants
|
10 Participants
|
|
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
3 = Hospitalized, no oxygen therapy
|
0 Participants
|
0 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
|
0 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, 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 D - Ivermectin 600
n=718 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=741 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
20 score on a scale
Interval 17.0 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 19.0 to 20.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Day 28
|
20 score on a scale
Interval 19.0 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, 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 D - Ivermectin 600
n=718 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=741 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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 14.0
|
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 8.0
|
|
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, 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 D - Ivermectin 600
n=718 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=741 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
6 score on a scale
Interval 4.0 to 9.0
|
|
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 6.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Day 28
|
4 score on a scale
Interval 4.0 to 6.0
|
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 5.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 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 domain 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 D - Ivermectin 600
n=718 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=741 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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 7.0
|
4 score on a scale
Interval 4.0 to 7.0
|
|
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, 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 D - Ivermectin 600
n=718 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=741 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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 6.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Day 90
|
4 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 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 D - Ivermectin 600
n=718 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=741 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
16 score on a scale
Interval 13.0 to 20.0
|
16 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 18.0 to 20.0
|
20 score on a scale
Interval 18.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 7, 14, 28, 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 D - Ivermectin 600
n=718 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=741 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
Day 7
|
10 score on a scale
Interval 7.0 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
Day 14
|
9 score on a scale
Interval 6.0 to 12.0
|
9 score on a scale
Interval 6.0 to 12.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Day 28
|
8 score on a scale
Interval 6.0 to 11.0
|
8 score on a scale
Interval 6.0 to 11.0
|
|
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
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 daysPopulation: Data not collected on 50 participants.
The 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. Measure of dispersion is 95% credible interval.
Outcome measures
| Measure |
Arm D - Ivermectin 600
n=685 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=697 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
11.24 days
Interval 11.05 to 11.42
|
11.28 days
Interval 11.09 to 11.45
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: Data not collected on 50 participants.
The 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 D - Ivermectin 600
n=685 Participants
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=697 Participants
Placebo - appearance and size matched to active study drug.
Participant will be instructed to take a pre-specified number of tablets for 6 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
|
3.39 days
Interval 3.17 to 3.61
|
3.34 days
Interval 3.13 to 3.55
|
Adverse Events
Arm D - Ivermectin 600
Serious events: 6 serious events
Other events: 18 other events
Deaths: 1 deaths
Arm D - Placebo
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm D - Ivermectin 600
n=708 participants at risk
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=724 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 6 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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Broken Ankle
|
0.00%
0/708 • 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.
|
0.14%
1/724 • 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.
|
|
Nervous system disorders
Syncope
|
0.14%
1/708 • 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.
|
0.00%
0/724 • 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.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/708 • 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.
|
0.14%
1/724 • 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.
|
|
General disorders
Chest Pain
|
0.00%
0/708 • 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.
|
0.14%
1/724 • 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.
|
|
Gastrointestinal disorders
Acute Pancreatitis
|
0.14%
1/708 • 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.
|
0.00%
0/724 • 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.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.14%
1/708 • 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.
|
0.00%
0/724 • 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.
|
|
Renal and urinary disorders
Urinary tract infection bacterial
|
0.14%
1/708 • 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.
|
0.00%
0/724 • 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.
|
|
Injury, poisoning and procedural complications
Accidental Death
|
0.14%
1/708 • 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.
|
0.00%
0/724 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.14%
1/708 • 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.
|
0.00%
0/724 • 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.
|
|
Injury, poisoning and procedural complications
Lithium toxicity
|
0.00%
0/708 • 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.
|
0.14%
1/724 • 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.
|
|
Psychiatric disorders
Mania
|
0.00%
0/708 • 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.
|
0.14%
1/724 • 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.
|
Other adverse events
| Measure |
Arm D - Ivermectin 600
n=708 participants at risk
Ivermectin - 7-mg tablets
Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 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 D - Placebo
n=724 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 6 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.
|
|---|---|---|
|
Nervous system disorders
Light sensitivity to eye
|
0.71%
5/708 • 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.
|
0.00%
0/724 • 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.
|
|
Eye disorders
Blurred vision
|
0.71%
5/708 • 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.
|
0.00%
0/724 • 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.
|
|
Eye disorders
Vision abnormal
|
0.28%
2/708 • 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.
|
0.00%
0/724 • 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.
|
|
Eye disorders
Vision blurred
|
0.14%
1/708 • 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.
|
0.00%
0/724 • 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.
|
|
Nervous system disorders
Photophobia
|
0.56%
4/708 • 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.
|
0.00%
0/724 • 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.
|
|
Eye disorders
Vision peripheral defective
|
0.14%
1/708 • 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.
|
0.00%
0/724 • 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.
|
|
Eye disorders
Blurry vision
|
0.00%
0/708 • 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.
|
0.14%
1/724 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place