Trial Outcomes & Findings for Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients (NCT NCT04603924)
NCT ID: NCT04603924
Last Updated: 2025-05-15
Results Overview
Incidence of Treatment Emergent Adverse Events (TEAEs)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
49 participants
Primary outcome timeframe
Randomization to Day 60
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
ANA001
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
Subjects Dosed
|
23
|
23
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
| Measure |
ANA001
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Overall Study
Not Dosed
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Adverse Event
|
2
|
2
|
Baseline Characteristics
Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients
Baseline characteristics by cohort
| Measure |
ANA001
n=25 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
n=24 Participants
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 -<40 Years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Customized
40-<65 Years
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Customized
>/=65 Years
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Days from First COVID-19 Symptom to Randomisation
|
7.6 Days
STANDARD_DEVIATION 4.12 • n=99 Participants
|
7.7 Days
STANDARD_DEVIATION 3.53 • n=107 Participants
|
7.7 Days
STANDARD_DEVIATION 3.81 • n=206 Participants
|
|
Baseline WHO Ordinal Scale for Clinical Improvement
Baseline World Health Organisation (WHO) Ordinal Scale for Clinical Improvement= 4
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Baseline WHO Ordinal Scale for Clinical Improvement
Baseline World Health Organisation (WHO) Ordinal Scale for Clinical Improvement = 5
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Baseline WHO Ordinal Scale for Clinical Improvement
Baseline World Health Organisation (WHO) Ordinal Scale for Clinical Improvement = 6
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Baseline WHO Ordinal Scale for Clinical Improvement
Baseline World Health Organisation (WHO) Ordinal Scale for Clinical Improvement = Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Randomization to Day 60Population: Safety Analysis Set: Includes all randomized participants, classified according to the actual treatment received regardless of randomization assignment, who received any amount of study drug and have at least one post-baseline safety evaluation. This is the analysis population for all planned safety analyses.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Outcome measures
| Measure |
ANA001
n=22 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
n=23 Participants
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Number of Subjects Experiencing TEAEs
No. of Subjects with any TEAE
|
16 Participants
|
12 Participants
|
|
Number of Subjects Experiencing TEAEs
No. of Subjects with Mild (Grade 1) TEAEs
|
9 Participants
|
2 Participants
|
|
Number of Subjects Experiencing TEAEs
No. of Subjects with Moderate (Grade 2) TEAEs
|
5 Participants
|
4 Participants
|
|
Number of Subjects Experiencing TEAEs
No. of Subjects with Severe (Grade 3) TEAEs
|
0 Participants
|
2 Participants
|
|
Number of Subjects Experiencing TEAEs
No. of Subjects with Life-Threatening (Grade 4) TEAEs
|
0 Participants
|
1 Participants
|
|
Number of Subjects Experiencing TEAEs
No. of Subjects with Death (Grade 5) TEAEs
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Randomization to Day 60Population: Safety Analysis Set: Includes all randomized participants, classified according to the actual treatment received regardless of randomization assignment, who received any amount of study drug and have at least one post-baseline safety evaluation. This is the analysis population for all planned safety analyses.
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)
Outcome measures
| Measure |
ANA001
n=22 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
n=23 Participants
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Number of Subjects Experiencing TESAEs
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Randomization to Day 60Median time until patient is discharged from hospital. Discharge is defined as a score of 1 or 2 in the WHO Ordinal Scale for Clinical Improvement. This is a 9 point ordinal scale with 0 indicating "No clinical or virological evidence of infection" and 8 indicating "Death".
Outcome measures
| Measure |
ANA001
n=23 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
n=23 Participants
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Median Time to Hospital Discharge
|
6.03 Days
Interval 3.07 to 14.89
|
13.92 Days
Interval 5.85 to
Median time to hospital discharge and corresponding 95% C.I. were estimated from the Kaplan-Meier curves. In some cases the 95% confidence interval could not be calculated due primarily to censoring of data: Participants who are lost to follow-up as of the data analysis cutoff date are censored on the date of the participant's last known WHO Ordinal Scale for Clinical Improvement; Participants who die in the hospital are right censored at Day 60 or date of death, whichever is earlier.
|
SECONDARY outcome
Timeframe: Randomization to Day 60Median Time to 2-point Improvement in WHO Ordinal Scale for Clinical Improvement. This is a 9 point ordinal scale with 0 indicating "No clinical or virological evidence of infection" and 8 indicating "Death"
Outcome measures
| Measure |
ANA001
n=23 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
n=23 Participants
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Median Time to 2-point Improvement WHO Clinical Improvement Scale
|
4.15 Days
Interval 2.98 to 6.96
|
13.91 Days
Interval 5.85 to
Median Time to 2-point Improvement in WHO Ordinal Scale for Clinical Improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves. In some cases the 95% confidence interval could not be calculated by this method primarily due to data censoring: participants lost to follow up are censored on the date of the participant's last known WHO Ordinal Scale for Clinical Improvement. Participants who die in the hospital are right censored at Day 60.
|
SECONDARY outcome
Timeframe: Randomization to Day 60Median time (in days) to resolution of subjective symptoms assessed by the Investigator to be potentially due to COVID-19 including: fever, cough (productive or non-productive), sore throat, malaise, headache, muscle pain, gastrointestinal symptoms (i.e., nausea, vomiting, or diarrhea), shortness of breath (with or without exertion), and respiratory distress
Outcome measures
| Measure |
ANA001
n=23 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
n=23 Participants
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Median Time to Resolution of COVID-19 Symptoms
|
17 Days
Interval 9.0 to 36.0
|
16 Days
Interval 11.0 to 24.0
|
SECONDARY outcome
Timeframe: Randomization to Day 60Median number of days to viral load undetectable by nasopharyngeal (NP) swab
Outcome measures
| Measure |
ANA001
n=23 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
n=23 Participants
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Median Time to Time-to-Viral Load Undetectable
|
13.09 Days
Interval 2.87 to 27.04
|
13.1 Days
Interval 2.99 to 15.1
|
SECONDARY outcome
Timeframe: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.Population: Day 1 data only available for 7 subjects
Area under the drug concentration (h\*ng/mL) (AUC) vs time curve on Days 1 and 2
Outcome measures
| Measure |
ANA001
n=11 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
AUC 0-t (h*ng/mL)
Day 1: AUC 0-t (h*ng/mL)
|
1728.6 h*ng/mL
Standard Deviation 1410.21
|
—
|
|
AUC 0-t (h*ng/mL)
Day 2: AUC 0-t (h*ng/mL)
|
2839.0 h*ng/mL
Standard Deviation 1702.25
|
—
|
SECONDARY outcome
Timeframe: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.Population: Day 1 data only available for 7 subjects
Maximum post dose plasma drug concentration on \[Cmax (ng/mL)\] Days 1 and 2
Outcome measures
| Measure |
ANA001
n=11 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Cmax (ng/mL)
Day 1: Cmax (ng/mL)
|
348.06 ng/mL
Standard Deviation 212.343
|
—
|
|
Cmax (ng/mL)
Day 2: Cmax (ng/mL)
|
435.91 ng/mL
Standard Deviation 204.059
|
—
|
SECONDARY outcome
Timeframe: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.Population: Day 1 data only available for 7 subjects
Time to maximum post dose plasma drug concentration on \[Tmax (h)\] Days 1 and 2
Outcome measures
| Measure |
ANA001
n=11 Participants
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Tmax (h)
Day 1: Tmax (h)
|
4.884 (h)
Standard Deviation 2.3139
|
—
|
|
Tmax (h)
Day 2: Tmax (h)
|
3.983 (h)
Standard Deviation 2.4002
|
—
|
Adverse Events
ANA001
Serious events: 3 serious events
Other events: 16 other events
Deaths: 2 deaths
Matching Placebo
Serious events: 6 serious events
Other events: 12 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
ANA001
n=22 participants at risk
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
n=23 participants at risk
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Infections and infestations
Septic shock
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
13.0%
3/23 • Number of events 3 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Infections and infestations
Sepsis
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
17.4%
4/23 • Number of events 4 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Vascular disorders
Deep vein thrombosis
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
Other adverse events
| Measure |
ANA001
n=22 participants at risk
Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity
|
Matching Placebo
n=23 participants at risk
Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.
Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
13.0%
3/23 • Number of events 3 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
21.7%
5/23 • Number of events 5 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Psychiatric disorders
Confusional state
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Psychiatric disorders
Hallucination
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Psychiatric disorders
Mania
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Psychiatric disorders
Mental status changes
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Psychiatric disorders
Nightmare
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
2/22 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
13.0%
3/23 • Number of events 3 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
2/22 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
2/22 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
2/22 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
8.7%
2/23 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
8.7%
2/23 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hyperferritinaemia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
8.7%
2/23 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Infections and infestations
Otitis Media
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Infections and infestations
Pneumonia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Infections and infestations
Oral candiasis
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Nervous system disorders
Metabolic encephalopathy
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
8.7%
2/23 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
8.7%
2/23 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
8.7%
2/23 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
2/22 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Blood and lymphatic system disorders
Pneumomediatinum
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
General disorders
Pyrexia
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Investigations
C-reactive protein increases
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
8.7%
2/23 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
8.7%
2/23 • Number of events 2 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Investigations
Granulocyte count increased
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Investigations
Immature granulocyte percentage increased
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Investigations
Klebsiella test positive
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Renal and urinary disorders
End stage renal disease
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
0.00%
0/23 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Skin and subcutaneous tissue disorders
subcutaneous emphysema
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/22 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
4.5%
1/22 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
4.3%
1/23 • Number of events 1 • TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place