Covid19Phase 2NCT04555096

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

A Phase 2 study testing GC4419 in people with Covid19 and SARS-CoV-2 Infection, run by Galera Therapeutics, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A Trial of GC4419 in Patients with Critical Illness due to COVID-19 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, SARS-CoV-2 Infection
What is being tested?: GC4419
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 3 sitesUnited States
Study dates: 9 Sep 2020to 28 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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

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

Conditions: Covid19, SARS-CoV-2 Infection
Being tested: GC4419, Placebo
Keywords: COVID19, SARS-CoV-2 Infection
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GC4419Drug
Also called Avasopasem
180 Minute IV Infusion
PlaceboDrug
180 Minute IV Infusion

Study groups in NCT04555096
Study group	Role	What they receive
Active GC4419	Experimental	Arm A Receives: Drug: GC4419
Placebo	Placebo comparator	Arm B Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 202028 May 2021

First posted18 Sep 2020
Study start9 Sep 2020
Primary completion28 May 2021
Study completion28 May 2021

Why it stopped: Participants are no longer receiving intervention

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04555096
Sponsor's protocol ID: COV-4419-201
Status last verified: Mar 2022
First submitted: 16 Sep 2020
Last updated: 18 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)
ClinicalTrials.gov ID: NCT04555096
Acronym / sponsor ID: COV-4419-201
Conditions: Covid19, SARS-CoV-2 Infection
Keywords: COVID19, SARS-CoV-2 Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Participants are no longer receiving intervention
Enrolment: 16 participants (actual)
Lead sponsor: Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 9 Sep 2020 (actual)
Primary completion: 28 May 2021 (actual)
Study completion: 28 May 2021 (actual)
First posted: 18 Sep 2020 (actual)
Results: Posted 18 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active GC4419	Experimental	Drug: GC4419Arm A
Placebo	Placebo comparator	Drug: PlaceboArm B

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GC4419Also: Avasopasem180 Minute IV Infusion	Drug	Active GC4419
Placebo180 Minute IV Infusion	Drug	Placebo

Primary outcome

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

Results and safety

Results posted to the registry on 18 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active GC4419	9	4
Placebo	7	2

Primary outcome: 28 Day All-cause Mortality

Time frame: 28 days. Count of participants. Unit: Participants

Measure	Active GC4419 n = 9	Placebo n = 7
Alive	5	3
Death	4	4

Adverse events

Time frame: Adverse events collected from the baseline visit until 30 days after the last dose of GC4419/Placebo. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active GC4419	5 of 9 (55.6%)	8 of 9 (88.9%)	4 of 9
Placebo	4 of 7 (57.1%)	7 of 7 (100%)	4 of 7

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33050459Karlsson 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jon Holmlund, MD study chair

Study Chair

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GC4419 in people with Covid19 and SARS-CoV-2 Infection, run by Galera Therapeutics, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28 Day All-cause Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04555096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.