NCT04555096

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 18, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

September 16, 2020

Results QC Date

March 14, 2022

Last Update Submit

March 14, 2022

Conditions

Covid19SARS-CoV-2 Infection

Keywords

COVID19SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

  • 28 Day All-cause Mortality

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

    28 days

Study Arms (2)

Active GC4419

EXPERIMENTAL

Arm A

Drug: GC4419

Placebo

PLACEBO COMPARATOR

Arm B

Drug: Placebo

Interventions

GC4419DRUG

180 Minute IV Infusion

Also known as: Avasopasem
Active GC4419
PlaceboDRUG

180 Minute IV Infusion

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Mercy Research

St Louis, Missouri, 63141, United States

Location

Related Publications (1)

  • 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.

    PMID: 33050459DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

avasopasem manganese

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

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.

Results Point of Contact

Title
Judy Schnyder, SVP Clinical Operations and Data Management
Organization
Galera Therapeutics
jschnyder@galeratx.com
2155937119

Study Officials

  • Jon Holmlund, MD

    Study Chair

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 18, 2020

Study Start

September 9, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

March 18, 2022

Results First Posted

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)