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Trial - NCT04555096


Column Value
Trial registration number NCT04555096
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04555096

First author
Last imported at : July 15, 2021, 6 a.m.
Source : ClinicalTrials.gov

George Matuschak, MD

Contact
Last imported at : July 15, 2021, 6 a.m.
Source : ClinicalTrials.gov

Amanda Sanders, info@galeratx.com (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-18

Recruitment status
Last imported at : July 15, 2021, 6 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Galera Therapeutics, Inc.

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

8: Critical disease at enrollment

Total sample size
Last imported at : March 20, 2022, 9:56 a.m.
Source : ClinicalTrials.gov

16

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

28 day all-cause mortality

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 152, "treatment_name": "Avasopasem manganese", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]