Covid-19, Pulmonary Infection
Conditions
Keywords
Covid-19, Pulmonary Infection, T3, Triiodothyronine, SARS-CoV-2
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.
Interventions
DRUGT3 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.
DRUGPlacebo
Same as with T3 solution for injection.
Sponsors
Attikon Hospital
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind
Intervention model description
Phase II, parallel, prospective, randomized, double-blind, placebo controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of weaning from cardiorespiratory support | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pulmonary function | 30 days | Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of oxygen in mmHg) |
| Assessment of hepatic function | 30 days | Hepatic function will be assessed by laboratory measurements in blood. Changes in aspartate aminotransferase (AST in IU/L) will be measured. |
| Assessment of renal function | 30 days | Urine volume during 24 hours (in ml) will be recorded. |
| Assessment of hemodynamic status | 30 days | Hemodynamic status will be assessed by continuous blood pressure measurements (systolic BP in mmHg) |
| Assessment of cardiac injury | 30 days | Measurements of cardiac troponin I (in μg/L) will be used to assess myocardial injury |
| Assessment of the course of COVID-19 infection | 30 days | COVID-19 infection will be assessed by inflammatory indices in blood (white blood cells in number per μL) |
| Assessment of clinical outcome and safety | 30 days | 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 |
| Assessment of cardiac function | 30 days | Echocardiographic assessment of cardiac left ventricular ejection fraction (LVEF, %) |
Countries
Greece
Outcome results
None listed