Trial Outcomes & Findings for Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial (NCT NCT05822583)
NCT ID: NCT05822583
Last Updated: 2026-08-31
Results Overview
Number of participants who recovered by Day 60. Recovery was assessed through Day 60 using the Days to Recovery Scale.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
285 participants
Primary outcome timeframe
Through Day 60
Results posted on
2026-08-31
Participant Flow
Participant milestones
| Measure |
Active Treatment Group
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
Control Group
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
144
|
|
Overall Study
COMPLETED
|
139
|
139
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Active Treatment Group
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
Control Group
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
No Infusion
|
1
|
5
|
Baseline Characteristics
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial
Baseline characteristics by cohort
| Measure |
Active Treatment Group
n=140 Participants
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
Control Group
n=139 Participants
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 13.9 • n=14 Participants
|
70.1 years
STANDARD_DEVIATION 11.8 • n=36 Participants
|
69.4 years
STANDARD_DEVIATION 12.9 • n=324 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=14 Participants
|
73 Participants
n=36 Participants
|
149 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=14 Participants
|
66 Participants
n=36 Participants
|
130 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=14 Participants
|
9 Participants
n=36 Participants
|
18 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=14 Participants
|
16 Participants
n=36 Participants
|
27 Participants
n=324 Participants
|
|
Race (NIH/OMB)
White
|
116 Participants
n=14 Participants
|
110 Participants
n=36 Participants
|
226 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
PRIMARY outcome
Timeframe: Through Day 60Number of participants who recovered by Day 60. Recovery was assessed through Day 60 using the Days to Recovery Scale.
Outcome measures
| Measure |
Control Group
n=137 Participants
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
Active Treatment Group
n=132 Participants
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
|---|---|---|
|
Number of Participants Recovered by Day 60
|
118 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: Through Day 28Number of participants who experienced death, SAE, clinical organ failure, serious infections, or a Grade 3 or 4 event through day 28
Outcome measures
| Measure |
Control Group
n=139 Participants
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
Active Treatment Group
n=140 Participants
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
|---|---|---|
|
Safety Outcome Through Day 28
|
39 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Through Day 120Number of participants who experienced death or CRIs through day 120
Outcome measures
| Measure |
Control Group
n=139 Participants
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
Active Treatment Group
n=140 Participants
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
|---|---|---|
|
Composite of Death or CRIs
|
14 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Through Day 60Number of participants who experienced clinical progression or death through Day 60.
Outcome measures
| Measure |
Control Group
n=139 Participants
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
Active Treatment Group
n=140 Participants
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
|---|---|---|
|
Number of Participants With Clinical Progression or Death Through Day 60
|
18 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Through Day 60Number of participants who returned to their baseline residence/home for at least 14 consecutive days through Day 60.
Outcome measures
| Measure |
Control Group
n=139 Participants
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
Active Treatment Group
n=140 Participants
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
|---|---|---|
|
Number of Participants With Sustained Recovery Through Day 60
|
127 Participants
|
122 Participants
|
Adverse Events
Active Treatment Group
Serious events: 15 serious events
Other events: 18 other events
Deaths: 0 deaths
Control Group
Serious events: 17 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Treatment Group
n=140 participants at risk
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
Control Group
n=139 participants at risk
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
|---|---|---|
|
Infections and infestations
Pneumonia pneumococcal
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Gastrointestinal disorders
Asthenia
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Influenza
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Pneumonia aspiration
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Pneumonia viral
|
1.4%
2/140 • Number of events 2 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Pyelonephritis
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Sepsis
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Sepsis shock
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
1.4%
2/139 • Number of events 2 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Haemophilus infection
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
3.6%
5/139 • Number of events 5 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
2.2%
3/139 • Number of events 3 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Vascular disorders
Haematoma
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Vascular disorders
Hypertension
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Vascular disorders
Hypotension
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
Other adverse events
| Measure |
Active Treatment Group
n=140 participants at risk
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
abatacept infusion: The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of \>175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator)
|
Control Group
n=139 participants at risk
Placebo group (IV infusion of normal saline) + baseline IM
Placebo group: Placebo group (IV infusion of normal saline) + baseline IM
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Cardiac disorders
Angina pectoris
|
0.71%
1/140 • Number of events 2 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Cardiac disorders
Atrial fibrillation
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
1.4%
2/139 • Number of events 2 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
General disorders
Chest pain
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
General disorders
Non-cardiac chest pain
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Immune system disorders
Drug hypersensitivity
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Acute sinusitis
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Empyema
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Otitis media acute
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Sepsis
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Sepsis shock
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Injury, poisoning and procedural complications
Fall
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Nervous system disorders
Syncope
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Psychiatric disorders
Dilirium
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
1.4%
2/139 • Number of events 2 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
6/140 • Number of events 6 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
5.0%
7/139 • Number of events 8 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.71%
1/140 • Number of events 2 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
2/140 • Number of events 3 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.71%
1/140 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/140 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.72%
1/139 • Number of events 1 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
|
Vascular disorders
Hypertension
|
1.4%
2/140 • Number of events 6 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
0.00%
0/139 • Adverse events, and serious adverse events were assessed through day 60. Death and Clinically Relevant Infection (CRI) was assessed through day 120.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place