NCT05277285

Brief Summary

The primary purpose is to describe the safety of administration of three doses of STS to critically ill patients with confirmed COVID-19. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Apr 2022

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

March 10, 2022

Last Update Submit

January 11, 2023

Conditions

COVID-19Virus DiseasesCorona Virus Infection

Keywords

COVID-19SARS-CoV-2Hydrogen SulfideSodium ThiosulfateHydrogen Sulfide donor

Outcome Measures

Primary Outcomes (1)

  • Comparison of treatment-emergent serious and non-serious adverse events between treatment groups.

    Change in the number of adverse events (AEs) and serious adverse events (SAEs) among treatment groups

    Visit study day 28

Secondary Outcomes (12)

  • World Health Organization clinical progression scale (WHO-CPS) on day 7 from inclusion in the study

    Visit study day 7

  • WHO-CPS on day 14 from inclusion in the study

    Visit study day 14

  • WHO-CPS on day 28 from inclusion in the study

    Visit study day 28

  • Average value of the total sequential organ failure assessment (SOFA) score on day 7

    Visit study day 7

  • Hydrogen sulfide concentrations daily until day 7 in patient's blood serum.

    Visit study day 1 until visit day 7

  • +7 more secondary outcomes

Study Arms (3)

Standard Treatment

NO INTERVENTION

The standard treatment includes the application of mechanical ventilation and / or support with the administration of inotropes and / or extracorporeal oxygenation (ECMO) and the intravenous administration of fluids and dexamethasone. The administration of any other immunosuppressive therapy, including tocilizumab and / or antimicrobials at the discretion of the therapists, is permitted.

One intravenous 12.5 gr STS - Treatment Group 1

EXPERIMENTAL

Patients will receive standard treatment and one intravenous (iv)12.5 gr STS in 60 minutes continuous intravenous infusion. STS is dissolved in a final volume of 100ml N/S 0.9% w/v,

Drug: Sodium Thiosulfate 25% Solution for Injection

Three intravenous doses of 12.5 gr STS - Treatment Group 2

EXPERIMENTAL

Patients will receive standard treatment and three intravenous doses of 12.5 g STS. STS is dissolved in a final volume of 100ml N/S 0.9% w/v. Each dose will be given in 60 minutes of continuous intravenous infusion with 48 hours intervals between each dose.

Drug: Sodium Thiosulfate 25% Solution for Injection

Interventions

Sodium Thiosulfate 25% Solution for InjectionDRUG

The drug will be administered via continuous infusion after being diluted to a concentration 12.5 gr/100ml

Also known as: NATRIUMTHIOSULFAT 25%
One intravenous 12.5 gr STS - Treatment Group 1Three intravenous doses of 12.5 gr STS - Treatment Group 2

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospitan of Athens KAT 2nd Department of ICU

Athens, Kifisia, 14561, Greece

RECRUITING

MeSH Terms

Conditions

COVID-19Virus DiseasesCoronavirus Infections

Interventions

sodium thiosulfateSolutionsInjections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Ioannis Alamanos, MD

    General Hospital of Athens KAT

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evangelos Giamarellos-Bourboulis, MD, PhD

CONTACT

+302107480662egiamarel@med.uoa.gr

Antigoni Kotsaki, MD, PhD

CONTACT

+306946637164scra@sepsis.gr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 14, 2022

Study Start

April 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)