Assessment of clinical improvement of critically ill patients with confirmed Covid-19 by administering of sodium thiosulfate MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: NATRIUM THIOSULFAT 25%
Product Name: NATRIUMTHIOSULFAT 25%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: SODIUM THIOSULFATE
CAS Number: 7772-98-7
Other descriptive name:
Sponsors
Hellenic Institute for the Study of Sepsis
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: -Age less than 18 years -Denial of written consent -Decision not to resuscitate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It has been described that in patients with critical COVID-19 disease with ARDS in the Intensive Care Unit there is significant hydrogen sulfide (H2S) deficiency. H2S exerts significant anti-inflammatory effects while competing with IL-6. Sodium thiosulfate (STS) is a known H2S donor available for intravenous administration used for to treat cyanide poisoning and the side effects of cisplatin and is being investigated for its cardioprotective effect in patients with myocardial infarction. The aim of this study is to determine whether administration of sodium thiosulfate as a slow-release hydrogen sulfide donor could improve the outcome of critically ill patients with confirmed COVID-19. ;Secondary Objective: A secondary purpose is to describe data on the clinical efficacy of administration of up to three doses of STS in critically ill patients with confirmed COVID-19. ;Primary end point(s): Comparison of treatment-emergent serious and non-serious adverse events between treatment groups. ;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison of treatment groups below: -WHO-CPS on day 7 from inclusion in the study -WHO-CPS on day 14 from inclusion in the study -WHO-CPS on day 28 of inclusion in the study -Average value of the total SOFA score on day 7 -Hydrogen sulfide concentrations daily until day 7 in patient’s blood serum. -Cytokine concentrations daily until day 7 in patient’s blood serum. -Production of cytokines from mononuclear cells of patient’s blood on days 1,4 and 7 ;Timepoint(s) of evaluation of this end point: Day 7 Day 14 Day 28 Day 1-7 Day 1,4,7 | — |
Countries
Greece
Contacts
Public ContactPresident of the Board
Hellenic Institute for the Study of Sepsis
Outcome results
None listed