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

UNI Pharma

Status and phase: Terminated; Phase 2

Conditions: Covid-19; Pulmonary Infection

Treatments: Drug: Placebo; Drug: T3 solution for injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04348513

T3inj-02/ThySupport

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 2 patient groups, including a placebo group

T3 solution for injection

Experimental group

Description:

T3 Solution for injection 10 μg/ml, each vial contains 150μg of liothyronine in a total volume of 15ml. The dose administered will be 0.8g/kg i.v. bolus starting within 60min after respiratory support and will be followed by an infusion of 0.113g. kg-1.h-1 i.v. for 48 hours (therapeutic dose). After the first 48h, a maintenance dose will be administered corresponding to 50% of the therapeutic dose (0.057g. kg-1.h-1 i.v.). Drug administration will stop after successful weaning or end of followup (maximum 30 days).

Treatment:

Drug: T3 solution for injection

Placebo

Placebo Comparator group

Description:

Composition identical apart from the active substance. Same dosage.

Treatment:

Drug: Placebo