Improvement of severe respiratory failure in Covid-19 patients

Phase 1

• Conditions: Assessment of clinical improvement of critically ill patients with confirmed Covid-19 by administering of sodium thiosulfate; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-000642-16-GR
• Lead Sponsor: Hellenic Institute for the Study of Sepsis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-16
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

-Age less than 18 years
-Denial of written consent
-Decision not to resuscitate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified