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Trial - EUCTR2022-000642-16-GR


Column Value
Trial registration number EUCTR2022-000642-16-GR
Full text link
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000642-16/GR

First author
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Hellenic Institute for the Study of Sepsis - President of the Board

Contact
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

insepsis@otenet.gr

Registration date
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

2022-02-16

Recruitment status
Last imported at : Jan. 5, 2025, 10:55 p.m.
Source : EU Clinical Trials Register

Completed

Study design
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Treatment

Inclusion criteria
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

-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 -Ηλικία ίση ή μεγαλύτερη των 18 ετών -Και τα δύο φύλα -Για γυναίκες σε αναπαραγωγική ηλικία, πρέπει να χρησιμοποιούν ή να είναι πρόθυμες να χρησιμοποιήσουν μια διπλή μέθοδο αντισύλληψης κατά τη διάρκεια της μελέτης. -Γραπτή δήλωση συγκατάθεσης που παρέχεται από τον ασθενή ή τον νόμιμο εκπρόσωπό του σε περίπτωση που οι ασθενείς δεν μπορούν να συναινέσουν. -Επιβεβαιωμένη νόσος COVID-19 -WHO-CPS 7 έως 9 -Νοσηλεία σε Μονάδα Εντατικής Θεραπείας -Επίπεδα H2S ορού μικρότερα από 140 μM

Exclusion criteria
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

-Age less than 18 years -Denial of written consent -Decision not to resuscitate -Ηλικία κάτω των 18 ετών -Άρνηση γραπτής συγκατάθεσης -Απόφαση για μη αναζωογόνηση

Number of arms
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

3

Funding
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Hellenic Institute for the Study of Sepsis

Inclusion age min
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Greece

Type of patients
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Critical disease at enrollment

Severity scale
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

8: Critical disease at enrollment

Total sample size
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

30

primary outcome
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Comparison of treatment-emergent serious and non-serious adverse events between treatment groups. Σύγκριση σοβαρών και μη σοβαρών ανεπιθύμητων ενεργειών που προκύπτουν από τη θεραπεία μεταξύ των ομάδων θεραπείας.

Notes
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Declared number of arm (3.0) differs from found arms (1.0)

Phase
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

Phase 2

Arms
Last imported at : March 13, 2022, 2:55 p.m.
Source : EU Clinical Trials Register

[{"arm_notes": "dose not specified", "treatment_id": 2372, "treatment_name": "Sodium thiosulfate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "dose not specified", "treatment_id": 2372, "treatment_name": "Sodium thiosulfate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "dose not specified", "treatment_id": 2372, "treatment_name": "Sodium thiosulfate", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]