Clinical trial NCT04348513: Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection
Official title: Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Infection
Covid-19
Keywords: Covid-19
Pulmonary Infection
T3
Triiodothyronine
SARS-CoV-2
Lead sponsor: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Sponsor class: INDUSTRY
Collaborators: name: Attikon Hospital
First posted: 2020-04-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase II, parallel, prospective, randomized, double-blind, placebo controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

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)

Primary outcomes:
measure: Assessment of weaning from cardiorespiratory support
timeFrame: 30 days
Secondary outcomes:
measure: Assessment of hemodynamic status
timeFrame: 30 days
measure: Assessment of hemodynamic status
timeFrame: 30 days
measure: Assessment of hemodynamic status
timeFrame: 30 days
measure: Assessment of hemodynamic status
timeFrame: 30 days
measure: Assessment of pulmonary function
timeFrame: 30 days
measure: Assessment of pulmonary function
timeFrame: 30 days
measure: Assessment of pulmonary function
timeFrame: 30 days
measure: Assessment of hepatic function
timeFrame: 30 days
measure: Assessment of hepatic function
timeFrame: 30 days
measure: Assessment of hepatic function
timeFrame: 30 days
measure: Assessment of hepatic function
timeFrame: 30 days
measure: Assessment of hepatic function
timeFrame: 30 days
measure: Assessment of hepatic function
timeFrame: 30 days
measure: Assessment of renal function
timeFrame: 30 days
measure: Assessment of renal function
timeFrame: 30 days
measure: Assessment of renal function
timeFrame: 30 days
measure: Assessment of renal function
timeFrame: 30 days
measure: Assessment of cardiac function
timeFrame: 30 days
measure: Assessment of cardiac injury
timeFrame: 30 days
measure: Assessment of the course of COVID-19 infection
timeFrame: 30 days
measure: Assessment of the course of COVID-19 infection
timeFrame: 30 days
measure: Assessment of the course of COVID-19 infection
timeFrame: 30 days
measure: Assessment of the course of COVID-19 infection
timeFrame: 30 days
measure: Assessment of the course of COVID-19 infection
timeFrame: 30 days
measure: Assessment of clinical outcome and safety
timeFrame: 30 days
measure: Assessment of clinical outcome and safety
timeFrame: 30 days
Other outcomes:
Locations:
city: Haidari/Athens
country: Greece
facility: Attikon University General Hospital
Study officials:
affiliation: ATTIKON University General Hospital
name: Georgia Kostopanagiotou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pantos C, Apostolaki V, Kokkinos L, Trikas A, Mourouzis I. Acute triiodothyronine treatment and red blood cell sedimentation rate (ESR) in critically ill COVID-19 patients: A novel association? Clin Hemorheol Microcirc. 2021;79(3):485-488. doi: 10.3233/CH-211215.
citation: Pantos C, Kostopanagiotou G, Armaganidis A, Trikas A, Tseti I, Mourouzis I. Triiodothyronine for the treatment of critically ill patients with COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 26;21(1):573. doi: 10.1186/s13063-020-04474-0.