Triiodothyronine for the treatment of critically ill patients with COVID-19 infection (Thy-Support Study)

Triiodothyronine for the treatment of critically ill patients with COVID-19 infection (Thy-Support Study) - Thy-Support STUDY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001623-13-GR

Enrollment

Registered

2020-04-22

Start date

2020-05-20

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU patients diagnosed with pulmonary infection due to COVID-19 and require mechanical respiratory support or ECMO MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: T3® Solution for injection 10 µg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: LIOTHYRONINE SODIUM CAS Number: 55-06-1 Concentration unit: µg/ml microgram(s)/millil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Patients diagnosed with pulmonary infection due to COVID-19, admitted in ICU and require mechanical ventilation or ECMO •Male and female with Age>18 years old •Signed informed consent from patient or relatives 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: •Pregnant or breast-feeding women •Severe systemic disease (e.g. cancer) before infection accompanied by reduced life expectancy <6 months •Participation in another trial of an investigational drug or device

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to determine whether the administration of intravenous triiodothyronine in ICU patients diagnosed with pulmonary infection due to COVID-19 facilitates weaning from cardiorespiratory support compared to placebo.;Secondary Objective: 1.Assessment of hemodynamic status 2.Assessment of pulmonary function 3.Assessment of hepatic and renal function 4.Assessment of cardiac function 5.Assessment of the course of COVID-19 infection 6.Assessment of clinical outcome and safety;Primary end point(s): The primary end-point assessed in the present study will be the percentage of patients successfully weaned after 30 days of follow-up. Successful weaning is expected in 15% of patients in placebo group. We assume that T3 treatment can increase successful weaning to 50% of patients which is a significant clinical improvement in prognosis.;Timepoint(s) of evaluation of this end point: Treatment period will last till successful weaning or end of follow-up. Follow up will be performed for 1 month.	—

Measure

Time frame

Main Objective: The primary objective of the study is to determine whether the administration of intravenous triiodothyronine in ICU patients diagnosed with pulmonary infection due to COVID-19 facilitates weaning from cardiorespiratory support compared to placebo.;Secondary Objective: 1.Assessment of hemodynamic status 2.Assessment of pulmonary function 3.Assessment of hepatic and renal function 4.Assessment of cardiac function 5.Assessment of the course of COVID-19 infection 6.Assessment of clinical outcome and safety;Primary end point(s): The primary end-point assessed in the present study will be the percentage of patients successfully weaned after 30 days of follow-up. Successful weaning is expected in 15% of patients in placebo group. We assume that T3 treatment can increase successful weaning to 50% of patients which is a significant clinical improvement in prognosis.;Timepoint(s) of evaluation of this end point: Treatment period will last till successful weaning or end of follow-up. Follow up will be performed for 1 month.

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Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Greece

Contacts

Public ContactIoulia Tseti

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

unipharma@uni-pharma.gr00302108072512

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026