Trial Outcomes & Findings for A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 (NCT NCT04555096)
NCT ID: NCT04555096
Last Updated: 2022-03-18
Results Overview
Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
28 days
Results posted on
2022-03-18
Participant Flow
Participant milestones
| Measure |
Active GC4419
Arm A
GC4419: 180 Minute IV Infusion
|
Placebo
Arm B
Placebo: 180 Minute IV Infusion
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Active GC4419
Arm A
GC4419: 180 Minute IV Infusion
|
Placebo
Arm B
Placebo: 180 Minute IV Infusion
|
|---|---|---|
|
Overall Study
Death
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
Baseline characteristics by cohort
| Measure |
Active GC4419
n=9 Participants
Arm A
GC4419: 180 Minute IV Infusion
|
Placebo
n=7 Participants
Arm B
Placebo: 180 Minute IV Infusion
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 6.89 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 11.28 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 61.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (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
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysDeath rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.
Outcome measures
| Measure |
Active GC4419
n=9 Participants
Arm A
GC4419: 180 Minute IV Infusion
|
Placebo
n=7 Participants
Arm B
Placebo: 180 Minute IV Infusion
|
|---|---|---|
|
28 Day All-cause Mortality
Alive
|
5 Participants
|
3 Participants
|
|
28 Day All-cause Mortality
Death
|
4 Participants
|
4 Participants
|
Adverse Events
Active GC4419
Serious events: 5 serious events
Other events: 8 other events
Deaths: 4 deaths
Placebo
Serious events: 4 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Active GC4419
n=9 participants at risk
Arm A
GC4419: 180 Minute IV Infusion
|
Placebo
n=7 participants at risk
Arm B
Placebo: 180 Minute IV Infusion
|
|---|---|---|
|
Cardiac disorders
Cardiogenic Shock
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Cardiac disorders
Stress cardiomyopathy
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
22.2%
2/9 • Number of events 2 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
28.6%
2/7 • Number of events 2 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Increased respiratory failure
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
Other adverse events
| Measure |
Active GC4419
n=9 participants at risk
Arm A
GC4419: 180 Minute IV Infusion
|
Placebo
n=7 participants at risk
Arm B
Placebo: 180 Minute IV Infusion
|
|---|---|---|
|
Vascular disorders
Distributive shock
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Cardiac disorders
Arteriospasm coronary
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Cardiac disorders
Atrial Fibrillation
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Cardiac disorders
Cardiogenic Shock
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Cardiac disorders
Propofol infusion syndrome
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Cardiac disorders
Stress cardiomyopathy
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Gastrointestinal disorders
Parotitis
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
General disorders
Decreased appetite
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
General disorders
Pyrexia
|
33.3%
3/9 • Number of events 3 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
28.6%
2/7 • Number of events 2 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Infections and infestations
Acute sinusitis
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Infections and infestations
Pneumonia klebsiella
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Infections and infestations
Septic shock
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Investigations
Electrocardiogram QR prolonged
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Investigations
Electrocardiogram ST segment elevation
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
22.2%
2/9 • Number of events 2 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
22.2%
2/9 • Number of events 2 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
28.6%
2/7 • Number of events 2 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
3/9 • Number of events 3 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Metabolism and nutrition disorders
Malnutrition
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Renal and urinary disorders
Acute Kidney injury
|
22.2%
2/9 • Number of events 2 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
22.2%
2/9 • Number of events 2 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
28.6%
2/7 • Number of events 2 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
3/9 • Number of events 3 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
42.9%
3/7 • Number of events 3 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
11.1%
1/9 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
0.00%
0/7 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Skin and subcutaneous tissue disorders
Skin injury
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
General disorders
Hypotension
|
55.6%
5/9 • Number of events 5 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
General disorders
Shock
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
|
Respiratory, thoracic and mediastinal disorders
Increase respiratory failure
|
0.00%
0/9 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
14.3%
1/7 • Number of events 1 • Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo
|
Additional Information
Judy Schnyder, SVP Clinical Operations and Data Management
Galera Therapeutics
Phone: 2155937119
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place