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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05277285 |
|
Full text link
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
egiamarel@med.uoa.gr |
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Registration date
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
2022-03-14 |
|
Recruitment status
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: age equal to or older than 18 years both genders for women of childbearing potential, they must use or be willing to use a dual contraceptive method during the study. written consent statement provided by the patient or his / her legal representative in case patients are unable to consent. confirmed covid-19 disease who-cps 7 to 9 hospitalization in intensive care unit serum h2s levels less than 140 μm |
|
Exclusion criteria
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
age less than 18 years denial of written consent decision not to resuscitate |
|
Number of arms
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Hellenic Institute for the Study of Sepsis |
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Inclusion age min
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Greece |
|
Type of patients
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
|
Severity scale
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
|
Total sample size
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
30 |
|
primary outcome
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Comparison of treatment-emergent serious and non-serious adverse events between treatment groups. |
|
Notes
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : March 15, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Once-off", "treatment_id": 2372, "treatment_name": "Sodium thiosulfate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Three doses 48h apart", "treatment_id": 2372, "treatment_name": "Sodium thiosulfate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |