Trial Outcomes & Findings for Intravenous Infusion of CAP-1002 in Patients With COVID-19 (NCT NCT04623671)
NCT ID: NCT04623671
Last Updated: 2025-02-20
Results Overview
Number of all-cause mortality cases from start of treatment up to end of study. Survival was measured as the time between the date of the start of treatment and the date of death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Up to End of Study (Day 90)
Results posted on
2025-02-20
Participant Flow
Participant milestones
| Measure |
CAP-1002
Participants received 1 peripheral IV infusion of IP (2 × 75M for a total of 150M CDCs administered at the clinical site).
|
Placebo
Participants received 1 infusion of intervention matching placebo on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
CAP-1002
Participants received 1 peripheral IV infusion of IP (2 × 75M for a total of 150M CDCs administered at the clinical site).
|
Placebo
Participants received 1 infusion of intervention matching placebo on Day 1.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Death
|
5
|
5
|
Baseline Characteristics
Intravenous Infusion of CAP-1002 in Patients With COVID-19
Baseline characteristics by cohort
| Measure |
CAP-1002
n=28 Participants
Participants received 1 peripheral IV infusion of IP (2 × 75M for a total of 150M CDCs administered at the clinical site)
|
Placebo
n=27 Participants
Participants received 1 infusion of intervention matching placebo on Day 1
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 14.13 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
56.4 years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to End of Study (Day 90)Population: Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
Number of all-cause mortality cases from start of treatment up to end of study. Survival was measured as the time between the date of the start of treatment and the date of death.
Outcome measures
| Measure |
CAP-1002
n=28 Participants
Participants received 1 peripheral IV infusion of IP (2 × 75M for a total of 150M CDCs administered at the clinical site)
|
Placebo
n=27 Participants
Participants received 1 infusion of intervention matching placebo on Day 1
|
|---|---|---|
|
Safety of CAP-1002: Incidence of All-Cause Mortality
|
5 Participants
|
6 Participants
|
Adverse Events
CAP-1002
Serious events: 9 serious events
Other events: 21 other events
Deaths: 5 deaths
Placebo
Serious events: 7 serious events
Other events: 16 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
CAP-1002
n=28 participants at risk
Participants received 1 peripheral IV infusion of IP (2 × 75M for a total of 150M CDCs administered at the clinical site)
|
Placebo
n=27 participants at risk
Participants received 1 infusion of intervention matching placebo on Day 1
|
|---|---|---|
|
General disorders
Multiple organ dysfunction syndrome
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Covid-19
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Lung abscess
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Pneumonia pseudomonal
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Septic shock
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress failure
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.7%
3/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
7.4%
2/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
Other adverse events
| Measure |
CAP-1002
n=28 participants at risk
Participants received 1 peripheral IV infusion of IP (2 × 75M for a total of 150M CDCs administered at the clinical site)
|
Placebo
n=27 participants at risk
Participants received 1 infusion of intervention matching placebo on Day 1
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
7.4%
2/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
7.4%
2/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
11.1%
3/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Cardiac disorders
Atrial flutter
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Cardiac disorders
Bradycardia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Cardiac disorders
Pericardial effusion
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Congenital, familial and genetic disorders
Left ventricle outflow tract obstruction
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
7.4%
2/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Faecaloma
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Haematochezia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Gastrointestinal disorders
Odynophagia
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
General disorders
Asthenia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
General disorders
Hypothermia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
General disorders
Oedema peripheral
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
General disorders
Pyrexia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Immune system disorders
Drug hypersensitivity
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Balanitis candida
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Candida infection
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Cytomegalovirus oesophagitis
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Oesophageal candidiasis
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
7.4%
2/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Sepsis syndrome
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Septic shock
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
14.8%
4/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Serratia infection
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Urinary tract infection fungal
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Infections and infestations
Bronchopulmonary aspergillosis; Aspergillus infection
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Injury, poisoning and procedural complications
Tissue injury
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Investigations
Cryptococcus test positive
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Investigations
Electrocardiogram QT prolonged
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Investigations
Inflammatory marker increased
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Investigations
Transaminases increased
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Metabolism and nutrition disorders
Acidosis
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
7.4%
2/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
7.4%
2/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Nervous system disorders
Encephalopathy
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
7.4%
2/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Nervous system disorders
Spasmodic dysphonia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
14.8%
4/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.7%
3/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Vascular disorders
Deep vein thrombosis
|
7.1%
2/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Vascular disorders
Hypertension
|
3.6%
1/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
0.00%
0/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Vascular disorders
Hypotension
|
14.3%
4/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
7.4%
2/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/28 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
3.7%
1/27 • Up to end of study (Day 90).
Safety analysis set includes all enrolled participants who were randomized and received at least 1 dose of randomized investigational product, CAP-1002 or placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place