Trial Outcomes & Findings for Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19) (NCT NCT05877508)
NCT ID: NCT05877508
Last Updated: 2025-10-28
Results Overview
This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 90 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.
ACTIVE_NOT_RECRUITING
PHASE2
36 participants
Day 90
2025-10-28
Participant Flow
36 people were randomized and received an infusion.
Participant milestones
| Measure |
AER002
AER002 1200mg administered once by IV
|
Placebo
Placebo administered once by IV
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
12
|
|
Overall Study
COMPLETED
|
24
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19)
Baseline characteristics by cohort
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
n=5 Participants
|
43 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Days Since Infection To Which Long COVID Symptoms Are Attributed
|
740 days
n=5 Participants
|
769 days
n=7 Participants
|
740 days
n=5 Participants
|
|
BMI at Baseline
<18.5
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI at Baseline
18.5-24.9
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
BMI at Baseline
25.0-29.9
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
BMI at Baseline
>=30
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Time Since Most Recent SARS-CoV-2 Infection
|
509 Days
n=5 Participants
|
504 Days
n=7 Participants
|
504 Days
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 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
|
PRIMARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 90 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score
|
40.9 score on a scale
Interval 38.3 to 43.5
|
45.0 score on a scale
Interval 41.3 to 48.6
|
SECONDARY outcome
Timeframe: Day 30 and Day 180This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 30 and Day 180 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score
Day 30
|
40.7 score on a scale
Interval 38.1 to 43.3
|
41.7 score on a scale
Interval 38.0 to 45.4
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score
Day 180
|
41.7 score on a scale
Interval 39.1 to 44.3
|
44.4 score on a scale
Interval 40.7 to 48.0
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 90 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score
|
40.7 score on a scale
Interval 37.9 to 43.5
|
45.4 score on a scale
Interval 41.4 to 49.4
|
SECONDARY outcome
Timeframe: Day 30 and Day 180This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 30 and Day 180 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score
Day 30
|
40.3 score on a scale
Interval 37.5 to 43.1
|
42.7 score on a scale
Interval 38.7 to 46.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score
Day 180
|
41.3 score on a scale
Interval 38.4 to 44.1
|
43.8 score on a scale
Interval 39.8 to 47.8
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in the baseline adjusted mean Quality of Life 100-point Visual-Analogue-Scale at Day 90 post-infusion. 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Quality of Life (Global Health Score) 100-point Visual-Analogue Scale
|
53.2 units on a scale
Interval 47.3 to 59.0
|
62.6 units on a scale
Interval 54.3 to 70.9
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score at Day 90 post-infusion. 5-Item EuroQol EQ-5D-5L questions assess pain/difficulty in day-to-day activities over the past week. The 5-Item EuroQol EQ-5D-5L produces a score that typically ranges from 0 - 1, with a higher score indicating better quality of life.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score
|
0.51 score on a scale
Interval 0.42 to 0.61
|
0.67 score on a scale
Interval 0.53 to 0.8
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean DASI at Day 90 post-infusion. The Duke Activity Status Index is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points, which is linearly correlated with a patient's VO2 max and METs, as measured from cardiopulmonary exercise testing (CPET). It inquires about a person's ability to perform self-care, walk, climb stairs, run, do house and yard work, engage in sexual intercourse, and perform moderate recreational activities. A higher score indicates higher functional capacity.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Duke Activity Status Index (DASI)
|
35.6 score on a scale
Interval 31.5 to 39.7
|
40.2 score on a scale
Interval 34.3 to 46.1
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean COMPASS-31 score at Day 90 post-infusion. COMPASS-31 asks 31 questions related to autonomic dysfunction. The answer to each question generates a numeric score for the question, which is then summed at the end of the questionnaire. A total score out of 100 is generated summarizing orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, urinary, pupillomotor, temperature intolerance, and sexual impairment. The total score ranges from 0 to 100 and a higher score indicates more severe autonomic dysfunction.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Composite Autonomic Symptom Score-31 (COMPASS-31)
|
18.3 score on a scale
Interval 13.4 to 23.3
|
13.6 score on a scale
Interval 6.6 to 20.6
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean WHO-DAS 2.0 score at Day 90 post-infusion. The World Health Organization Disability Assessment Schedule 2.0 questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. The range is scored from 0-48, with a higher score indicating a higher level of disability.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0)
|
16.9 score on a scale
Interval 14.5 to 19.2
|
12.9 score on a scale
Interval 9.6 to 16.2
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the Patient Global Impression of Change (PGIC) scale at Day 90 post-infusion. The self-reported PGIC reflects a patient's belief about the efficacy of treatment. We used a modified PGIC scale which has been used to study pain syndromes and has been employed in other Long COVID clinical trials. It is a common data element developed by the National Institutes of Mental Health. The PGIC ranges from 0 (Much better) to 10 (Much Worse). A score of 5 indicates no change.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Patient Global Impression of Change (PGIC) Scale
1
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
8
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
0 - Much Better
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
2
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
3
|
5 Participants
|
3 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
4
|
6 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
5 - No Change
|
7 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
6
|
3 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
7
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
9
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scale
10 - Much Worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean ECog-39 score at Day 90 post-infusion. The ECog-39 is an instrument that measures the decline in everyday cognitive and functional abilities that map to six cognitive domains, adapted specifically to describe change in abilities since having COVID. A summary ECog-39 score is calculated scored with a range of 1-4, with a higher score indicating greater cognitive impairment.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Everyday Cognition Form (ECog-39)
|
2.09 score on a scale
Interval 1.89 to 2.28
|
1.93 score on a scale
Interval 1.65 to 2.2
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean distance walked on the 6MWT at Day 90 post-infusion. The 6MWT requires an individual to walk at their normal pace for 6 minutes on a marked track (for example, a hallway). Vital signs are assessed, and the total distance covered is the primary outcome of interest.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
6 Minute Walking Test (6MWT)
|
426 meters
Interval 400.0 to 452.0
|
457 meters
Interval 420.0 to 495.0
|
SECONDARY outcome
Timeframe: Day 90The active standing test is a non-invasive tool to assess orthostatic hypotension (OH) and postural orthostatic tachycardia syndrome (POTS). In short, blood pressure and heart rate measurements were obtained after 5 minutes of resting supine and 1, 3, 5, and 10 minutes of continuous standing. Abnormal active standing test results were defined as those with a decline of \>20 mmHg in systolic or \> 10 mmHg in diastolic blood pressure in at least two consecutive measurements, or those with an increase in heart rate \> 30 bpm on two consecutive measurements.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Active Stand Test
Abnormal Active Stand Test
|
1 Participants
|
0 Participants
|
|
Active Stand Test
Normal Active Stand Test
|
23 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean NCI standard score from the CNS-VS at Day 90 post-infusion. The CNS Vital Signs is a a computer-based neurocognitive assessment comprised of seven tests: verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention and the continuous performance test. The battery gives a summary neurocognition index (NCI) score averaging five domain scores (Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility) and representing a global score of neurocognition. NCI scores are normalized scores (mean 100, standard deviation 15) that are age matched relative to other people in a normative sample. A higher score indicates better cognitive function.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Neurocognition Index (NCI) Standard Score From the CNS-VS
|
99.4 score on a scale
Interval 96.8 to 102.0
|
100.8 score on a scale
Interval 97.2 to 104.0
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean CRP concentration (mg/L) at Day 90 post-infusion.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
C-Reactive Protein (CRP)
|
1.52 mg/L
Interval 1.03 to 2.0
|
1.37 mg/L
Interval 0.68 to 2.06
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean ESR at Day 90 post-infusion.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR)
|
11.5 mm/hr
Interval 8.88 to 14.0
|
12.3 mm/hr
Interval 8.7 to 16.0
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean D-Dimer at Day 90 post-infusion.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
D-Dimer
|
0.31 mg/L FEU
Interval 0.29 to 0.33
|
0.33 mg/L FEU
Interval 0.29 to 0.36
|
SECONDARY outcome
Timeframe: Day 90This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean fibrinogen concentration (mg/dL) at Day 90 post-infusion.
Outcome measures
| Measure |
AER002
n=24 Participants
AER002 1200mg administered once by IV
|
Placebo
n=12 Participants
Placebo administered once by IV
|
|---|---|---|
|
Fibrinogen
|
315 mg/dL
Interval 298.0 to 332.0
|
299 mg/dL
Interval 275.0 to 323.0
|
Adverse Events
AER002
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AER002
n=24 participants at risk
AER002 1200mg administered once by IV
|
Placebo
n=12 participants at risk
Placebo administered once by IV
|
|---|---|---|
|
Infections and infestations
Rebound COVID-19
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Infections and infestations
Small intestinal bacterial overgrowth
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Infections and infestations
Suspected oral infection
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Blood and lymphatic system disorders
Decreased fibrinogen
|
8.3%
2/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle pain/aches
|
25.0%
6/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Pain at infusion site
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Pain
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Pelvic congestion syndrome
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Gout flare
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Torn meniscus
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Torn patellar cartilage
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Musculoskeletal and connective tissue disorders
Torn pulley ligament
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Trouble with balance/feeling unsteady
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Brain fog
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Head pressure
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Intractable chronic migraine with aura
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Lightheadedness
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Numbness
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Abnormal brain MRI
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Burning sensation in feet
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Nervous system disorders
Tingling
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Eye disorders
Blurry vision
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Eye disorders
Keratoconjunctivitissicca
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Eye disorders
Light sensitivity
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Cardiac disorders
Superficial thrombophlebitis
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Cardiac disorders
Hypertension
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Cardiac disorders
Hypotension
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Skin and subcutaneous tissue disorders
Bruise
|
8.3%
2/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Skin and subcutaneous tissue disorders
Localized rash
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Skin and subcutaneous tissue disorders
Skin pain
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Skin and subcutaneous tissue disorders
Localized itchiness
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Skin and subcutaneous tissue disorders
Cold sores
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
16.7%
2/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic rhinosinusitis
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Gastrointestinal disorders
Gastroenteritis
|
8.3%
2/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
25.0%
3/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
General disorders
Post-exertional malaise
|
12.5%
3/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
33.3%
4/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
General disorders
Fatigue
|
12.5%
3/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
General disorders
Pre-syncope
|
8.3%
2/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
General disorders
Chills
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
General disorders
Subjective fever
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Renal and urinary disorders
Dysuria
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Renal and urinary disorders
Kidney stone
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Renal and urinary disorders
Urinary tract infection
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
0.00%
0/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Renal and urinary disorders
Flank pain
|
0.00%
0/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Infections and infestations
Non-specific viral infection
|
29.2%
7/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Infections and infestations
SARS-CoV-2 infection - confirmed
|
25.0%
6/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
33.3%
4/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Infections and infestations
SARS-CoV-2 infection - suspected
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
16.7%
2/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
|
Infections and infestations
Skin/soft tissue infection
|
4.2%
1/24 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
8.3%
1/12 • Up to 12 Months
All gradable SAEs/AEs collected on study, regardless of relatedness to study drug
|
Additional Information
Michael Peluso
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place