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

A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04555096
Enrollment
16
Registered
2020-09-18
Start date
2020-09-09
Completion date
2021-05-28
Last updated
2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS-CoV-2 Infection

Keywords

COVID19, SARS-CoV-2 Infection

Brief summary

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

Interventions

DRUGGC4419

180 Minute IV Infusion

DRUGPlacebo

180 Minute IV Infusion

Sponsors

Galera Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male or female subjects at least 18 years of age. 2. Ability to understand and the willingness to sign a written informed consent. 3. Laboratory-confirmed SARS-CoV-2 infection as determined by a positive PCR test documented prior to randomization 4. Requirement for intensive inpatient hospital care 5. Acute hypoxemic respiratory failure typifying ARDS 6. Adequate liver function 7. Use of effective contraception

Exclusion criteria

1. Expected survival for less than 48 hours after randomization 2. Child-Pugh stage C hepatic impairment and/or portal hypertension secondary to cirrhosis 3. Stage IV chronic kidney disease or end-stage kidney disease on maintenance hemodialysis 4. Requirement for extra-corporeal membrane oxygenation (ECMO) 5. Acute Myocardial Infarction (AMI) 6. Active bleeding requiring transfusion 7. Concurrent participation in another clinical trial of experimental treatment for SARSCoV-2 8. Female patients who are pregnant or breastfeeding 9. Requirement for concurrent treatment with nitrates

Design outcomes

Primary

MeasureTime frameDescription
28 Day All-cause Mortality28 daysDeath rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.

Countries

United States

Participant flow

Participants by arm

ArmCount
Active GC4419
Arm A GC4419: 180 Minute IV Infusion
9
Placebo
Arm B Placebo: 180 Minute IV Infusion
7
Total16

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath44
Overall StudyOther01
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicActive GC4419TotalPlacebo
Age, Continuous62.7 years
STANDARD_DEVIATION 6.89
63.3 years
STANDARD_DEVIATION 61.5
64.0 years
STANDARD_DEVIATION 11.28
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants14 Participants7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants3 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants1 Participants
Race (NIH/OMB)
White
5 Participants10 Participants5 Participants
Region of Enrollment
United States
9 participants16 participants7 participants
Sex: Female, Male
Female
1 Participants4 Participants3 Participants
Sex: Female, Male
Male
8 Participants12 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 94 / 7
other
Total, other adverse events
8 / 97 / 7
serious
Total, serious adverse events
5 / 94 / 7

Outcome results

Primary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active GC441928 Day All-cause MortalityAlive5 Participants
Active GC441928 Day All-cause MortalityDeath4 Participants
Placebo28 Day All-cause MortalityAlive3 Participants
Placebo28 Day All-cause MortalityDeath4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026