Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection

Covid-19 Clinical Trial

— Thy-Support  

Official title:

Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04348513
• Other study ID #: T3inj-02/ThySupport
• Status: Terminated
• Phase: Phase 2
• Start date: May 29, 2020
• Est. completion date: April 19, 2021

Study information

• Verified date: September 2021
• Source: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a phase II, parallel, prospective, randomized, double-blind, placebo controlled trial. The present study will aim to address the efficacy and safety of acute administration of triiodothyronine on ICU patients diagnosed with pulmonary infection due to COVID-19 and require mechanical respiratory support or ECMO.

Description:

It seems that thyroid hormone is critical in the response to body injury and is now considered as potential pharmaceutical intervention to limit acute tissue injury. TH (via its regulation of stress induced p38 MAPK activation) exerts antiapoptotic action and protects tissue from injury, with additional favorable effects on immune system and on viral load in infected tissue. This may be a novel and more effective treatment for critically ill viral infected patients.

ThyRepair is the first study which is underway and investigates the safety and efficacy of high dose T3 treatment in patients with acute myocardial infarction undergoing primary angioplasty. The preliminary reports show that this treatment is safe and the efficacy on tissue repair is promising. This therapeutic modality could also be tested in the acute setting of sepsis in which thyroid hormone is involved in the pathophysiology of multi-organ dysfunction. The safety and efficacy of T3 on heamodynamics in sepsis has been previously demonstrated in a small trial.

The present study is phase II, parallel, prospective, randomized, double-blind, placebo controlled trial which aims to investigate the potential effect of T3 intravenous use in the recovery of critically ill patients admitted in ICU due to COVID19 infection.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 19, 2021
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Pregnant or breast-feeding women

• Severe systemic disease (cancer, auto-immune etc) before infection accompanied by reduced life expectancy <6 months

• Participation in another trial of an investigational drug or device

• Corticosteroid Use before initiation of treatment

• Sympathomimetic Use before initiation of treatment (epinephrine, norepinephrine, dobutamine, dopamine, phenylephrine)

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Pulmonary Infection

Intervention

Drug:
• T3 solution for injection
For example, for a patient of 77Kg of weight, a dose of 6ml (60 µg) will be administered as a bolus intravenously over 2-3 min within 60 min of respiratory support initiation. Then, the patient for the next 24 hours will receive 21ml of the product (total of 210 µg of T3) that will be diluted in NaCl 0.9% and administered with a pump at a steady flow rate of 10.4 ml/h for a total duration of 48 hours. From day 3 till successful weaning or end of follow-up, the patient will receive 50% of this dose, 10.5 ml of the product (total of 105 µg of T3) that will be diluted in NaCl 0.9% and administered with a pump at a steady flow rate of 5.2 ml/h.
• Placebo
Same as with T3 solution for injection.

Locations

Country	Name	City	State
Greece	Attikon University General Hospital	Haidari/Athens

Sponsors (2)

Lead Sponsor	Collaborator
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.	Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of weaning from cardiorespiratory support	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. Successful weaning is defined as no requirement for ventilatory support after extubation (mechanical support) or support from ECMO for 48 hours. The primary objective will be measured as percentage of patients successfully weaned after 30 days of follow-up.	30 days
Secondary	Assessment of hemodynamic status	Hemodynamic status will be assessed by continuous blood pressure measurements (systolic BP in mmHg)	30 days
Secondary	Assessment of hemodynamic status	Hemodynamic status will be assessed by continuous blood pressure measurements (diastolic BP in mmHg)	30 days
Secondary	Assessment of hemodynamic status	Hemodynamic status will be assessed by continuous blood pressure measurements (mean BP in mmHg)	30 days
Secondary	Assessment of hemodynamic status	Hemodynamic status will be assessed by the number of participants with use of inotropic and vasoactive drugs	30 days
Secondary	Assessment of pulmonary function	Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of oxygen in mmHg)	30 days
Secondary	Assessment of pulmonary function	Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of carbon dioxide in mmHg)	30 days
Secondary	Assessment of pulmonary function	Pulmonary function will be assessed by arterial measurement of lactate levels (in mmol/L)	30 days
Secondary	Assessment of hepatic function	Hepatic function will be assessed by laboratory measurements in blood. Changes in aspartate aminotransferase (AST in IU/L) will be measured.	30 days
Secondary	Assessment of hepatic function	Hepatic function will be assessed by laboratory measurements in blood. Changes in alanine aminotransferase (ALT in IU/L) will be measured.	30 days
Secondary	Assessment of hepatic function	Hepatic function will be assessed by laboratory measurements in blood. Changes in gamma-glutamyl transpeptidase (?-GT in IU/L) will be measured.	30 days
Secondary	Assessment of hepatic function	Hepatic function will be assessed by laboratory measurements in blood. Changes in bilirubin in mg/dL will be measured.	30 days
Secondary	Assessment of hepatic function	Hepatic function will be assessed by laboratory measurements in blood. Changes in fibrinogen in mg/dL will be measured.	30 days
Secondary	Assessment of hepatic function	Hepatic function will be assessed by laboratory measurements in blood. Changes in d-dimers in ng/ml will be measured.	30 days
Secondary	Assessment of renal function	Urine volume during 24 hours (in ml) will be recorded.	30 days
Secondary	Assessment of renal function	Changes in urea (in mg/dL) will be recorded.	30 days
Secondary	Assessment of renal function	Changes in uric acid (in mg/dL) will be recorded.	30 days
Secondary	Assessment of renal function	Changes in creatinine (in mg/dL) will be recorded.	30 days
Secondary	Assessment of cardiac function	Echocardiographic assessment of cardiac left ventricular ejection fraction (LVEF, %)	30 days
Secondary	Assessment of cardiac injury	Measurements of cardiac troponin I (in µg/L) will be used to assess myocardial injury	30 days
Secondary	Assessment of the course of COVID-19 infection	COVID-19 infection will be assessed by inflammatory indices in blood (white blood cells in number per µL)	30 days
Secondary	Assessment of the course of COVID-19 infection	COVID-19 infection will be assessed by inflammatory indices in blood (CRP in mg/L)	30 days
Secondary	Assessment of the course of COVID-19 infection	COVID-19 infection will be assessed by inflammatory indices in blood (erythrocyte sedimentation rate in mm/hr)	30 days
Secondary	Assessment of the course of COVID-19 infection	COVID-19 infection will be assessed by temperature monitoring (in degrees Celsius)	30 days
Secondary	Assessment of the course of COVID-19 infection	COVID-19 infection will be assessed by time needed (in days) for the patient to become negative in COVID-19	30 days
Secondary	Assessment of clinical outcome and safety	Number of participants with major (death, cardiac Arrest, electromechanical dissociation, pulmonary embolism, new myocardial infarction, stroke, pulmonary edema, cardiogenic shock and hypotension, septic shock, pulmonary embolism, serious bleeding) events be recorded during the follow up period	30 days
Secondary	Assessment of clinical outcome and safety	Number of participants with minor (myocarditis, Venous Thromboembolism, left Ventricular mural thrombus, renal failure, hepatic failure, stress ulcers, minor bleeding, paroxysmal supraventricular tachycardia and atrial fibrillation, rhythm disturbances) events will be recorded during the follow up period	30 days