A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
NCT ID: NCT04555096
Last Updated: 2022-03-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2020-09-09
2021-05-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
NanoMn®_COVID-19 A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
NCT05451654
A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19)
NCT04439071
Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
NCT04805671
Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)
NCT04547140
Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)
NCT04575584
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active GC4419
Arm A
GC4419
180 Minute IV Infusion
Placebo
Arm B
Placebo
180 Minute IV Infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GC4419
180 Minute IV Infusion
Placebo
180 Minute IV Infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Galera Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jon Holmlund, MD
Role: STUDY_CHAIR
Study Chair
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Iowa
Iowa City, Iowa, United States
Saint Louis University
St Louis, Missouri, United States
Mercy Research
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COV-4419-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.