TerminatedNCT04555096Updated Mar 18, 2022Results posted

A Trial of GC4419 in Patients With Critical Illness Due to COVID-19

A Phase 2 interventional study of GC4419 and Placebo in Covid19 and SARS-CoV-2 Infection, sponsored by Galera Therapeutics, Inc.. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Galera Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated

Participants are no longer receiving intervention

Phase: Phase 2
Study type: Interventional
Enrollment: 16
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

A Trial of GC4419 in Patients with Critical Illness due to COVID-19

Conditions studied

Covid19
SARS-CoV-2 Infection

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Keywords

COVID19
SARS-CoV-2 Infection

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 16 is below the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

Galera Therapeutics, Inc. is the lead sponsor of 17 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female subjects at least 18 years of age.
Ability to understand and the willingness to sign a written informed consent.
Laboratory-confirmed SARS-CoV-2 infection as determined by a positive PCR test documented prior to randomization
Requirement for intensive inpatient hospital care
Acute hypoxemic respiratory failure typifying ARDS
Adequate liver function
Use of effective contraception

Exclusion criteria

Exclusion Criteria:

Expected survival for less than 48 hours after randomization
Child-Pugh stage C hepatic impairment and/or portal hypertension secondary to cirrhosis
Stage IV chronic kidney disease or end-stage kidney disease on maintenance hemodialysis
Requirement for extra-corporeal membrane oxygenation (ECMO)
Acute Myocardial Infarction (AMI)
Active bleeding requiring transfusion
Concurrent participation in another clinical trial of experimental treatment for SARSCoV-2
Female patients who are pregnant or breastfeeding
Requirement for concurrent treatment with nitrates

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 16 participants (actual)

Study arms

Experimental
Active GC4419
Arm A
Drug: GC4419
Placebo comparator
Placebo
Arm B
Drug: Placebo

Interventions

DrugGC4419
180 Minute IV Infusion
Also known as: Avasopasem
DrugPlacebo
180 Minute IV Infusion

What researchers measure

Primary outcomes

28 Day All-cause Mortality
Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.
Time frame: 28 days

Results

Posted Mar 18, 2022

Limitations and caveats

Study was terminated early due to the inability to enroll critically ill COVID 19 patients as the height of the pandemic was over and the sites that were open for enrollment to the clinical study were no longer treating these types of patients.

Participant flow

Participant flow — Overall Study
Milestone	Active GC4419	Placebo
Started	9	7
Completed	4	2
Not completed	5	5
Withdrew: Death	4	4
Withdrew: Withdrawal by subject	1	0
Withdrew: Other	0	1

Outcome measures

Primary28 Day All-cause Mortality

Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.

Time frame:: 28 days
Reported as:: Count of participants · Participants

28 Day All-cause Mortality
Participants	Active GC4419	Placebo
Alive	5	3
Death	4	4

Adverse events

Collected over Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Active GC4419	4/9 (44.4%)	5/9 (55.6%)	8/9 (88.9%)
Placebo	4/7 (57.1%)	4/7 (57.1%)	7/7 (100%)

Most frequent serious events

Most frequent serious events
Event	Active GC4419	Placebo
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	2/9	2/7
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders	0/9	1/7
Pneumothorax spontaneousRespiratory, thoracic and mediastinal disorders	0/9	1/7
Increased respiratory failureRespiratory, thoracic and mediastinal disorders	0/9	1/7
Cardiogenic ShockCardiac disorders	1/9	0/7
Stress cardiomyopathyCardiac disorders	1/9	0/7
Retroperitoneal haematomaGastrointestinal disorders	1/9	0/7
Respiratory arrestRespiratory, thoracic and mediastinal disorders	1/9	0/7

Most frequent other events

Showing 10 of 47

Most frequent other events
Event	Active GC4419	Placebo
HypotensionGeneral disorders	5/9	1/7
HypoxiaRespiratory, thoracic and mediastinal disorders	3/9	3/7
PyrexiaGeneral disorders	3/9	2/7
HypophosphataemiaMetabolism and nutrition disorders	3/9	0/7
HypokalaemiaMetabolism and nutrition disorders	1/9	2/7
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	2/9	2/7
HyperkalaemiaMetabolism and nutrition disorders	2/9	0/7
HyperphosphataemiaMetabolism and nutrition disorders	2/9	0/7
Acute Kidney injuryRenal and urinary disorders	2/9	0/7
Blood loss anaemiaBlood and lymphatic system disorders	0/9	1/7

Baseline characteristics

Baseline analysis population is the same.

Age, Continuous
Age, Continuous(years)	Active GC4419	Placebo	Total
Mean	62.7 ± 6.89	64.0 ± 11.28	63.3 ± 61.5

Sex: Female, Male
Sex: Female, Male(Participants)	Active GC4419	Placebo	Total
Female	1	3	4
Male	8	4	12

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Active GC4419	Placebo	Total
Hispanic or Latino	2	0	2
Not Hispanic or Latino	7	7	14
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Active GC4419	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	1	3
White	5	5	10
More than one race	0	0	0
Unknown or Not Reported	2	1	3

Region of Enrollment
Region of Enrollment(participants)	Active GC4419	Placebo	Total
United States	9	7	16

Study locations

3 sites

University of Iowa
Iowa City, Iowa 52242, United States
Saint Louis University
Saint Louis, Missouri 63110, United States
Mercy Research
Saint Louis, Missouri 63141, United States

References and documents

Publications

Karlsson JOG, Jynge P, Ignarro LJ. May Mangafodipir or Other SOD Mimetics Contribute to Better Care in COVID-19 Patients? Antioxidants (Basel). 2020 Oct 10;9(10):971. doi: 10.3390/antiox9100971. PubMed 33050459 ↗

Study documents

Protocol and statistical analysis plan · Mar 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04555096
Lead sponsor: Galera Therapeutics, Inc.
Responsible party: Sponsor
First posted: Sep 18, 2020
Start date: Sep 9, 2020
Primary completion: May 28, 2021
Completion: May 28, 2021
Results posted: Mar 18, 2022
Last update: Mar 18, 2022

Study contacts

Jon Holmlund, MD

study chair · Study Chair

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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