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.
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.
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.
Drug: Placebo
Same as with T3 solution for injection.
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)
Attikon University General Hospital
Haidari/Athens, Greece
Georgia Kostopanagiotou, MD, Principal Investigator
ATTIKON University General Hospital