Pulmonary InfectionPhase 2Thy-SupportNCT04348513
Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection
A Phase 2 study testing T3 solution for injection in people with Pulmonary Infection and Covid-19, run by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Infection, Covid-19
- What is being tested?
- T3 solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteGreece
- Study dates
- 29 May 2020to 19 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support)
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.
Read the 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.
- Conditions
- Pulmonary Infection, Covid-19
- Being tested
- T3 solution for injection, Placebo
- Keywords
- Covid-19, Pulmonary Infection, T3, Triiodothyronine, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3 solution for injectionDrug
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.
PlaceboDrug
Same as with T3 solution for injection.
| Study group | Role | What they receive |
|---|---|---|
| T3 solution for injection | Experimental | 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). Receives: Drug: T3 solution for injection |
| Placebo | Placebo comparator | Composition identical apart from the active substance. Same dosage. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (26)
Assessment of hemodynamic status
Hemodynamic status will be assessed by continuous blood pressure measurements (systolic BP in mmHg)
Measured: 30 days
Assessment of hemodynamic status
Hemodynamic status will be assessed by continuous blood pressure measurements (diastolic BP in mmHg)
Measured: 30 days
Assessment of hemodynamic status
Hemodynamic status will be assessed by continuous blood pressure measurements (mean BP in mmHg)
Measured: 30 days
Assessment of hemodynamic status
Hemodynamic status will be assessed by the number of participants with use of inotropic and vasoactive drugs
Measured: 30 days
Assessment of pulmonary function
Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of oxygen in mmHg)
Measured: 30 days
Assessment of pulmonary function
Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of carbon dioxide in mmHg)
Measured: 30 days
Assessment of pulmonary function
Pulmonary function will be assessed by arterial measurement of lactate levels (in mmol/L)
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
Assessment of hepatic function
Hepatic function will be assessed by laboratory measurements in blood. Changes in gamma-glutamyl transpeptidase (γ-GT in IU/L) will be measured.
Measured: 30 days
Assessment of hepatic function
Hepatic function will be assessed by laboratory measurements in blood. Changes in bilirubin in mg/dL will be measured.
Measured: 30 days
Assessment of hepatic function
Hepatic function will be assessed by laboratory measurements in blood. Changes in fibrinogen in mg/dL will be measured.
Measured: 30 days
Assessment of hepatic function
Hepatic function will be assessed by laboratory measurements in blood. Changes in d-dimers in ng/ml will be measured.
Measured: 30 days
Assessment of renal function
Urine volume during 24 hours (in ml) will be recorded.
Measured: 30 days
Assessment of renal function
Changes in urea (in mg/dL) will be recorded.
Measured: 30 days
Assessment of renal function
Changes in uric acid (in mg/dL) will be recorded.
Measured: 30 days
Assessment of renal function
Changes in creatinine (in mg/dL) will be recorded.
Measured: 30 days
Assessment of cardiac function
Echocardiographic assessment of cardiac left ventricular ejection fraction (LVEF, %)
Measured: 30 days
Assessment of cardiac injury
Measurements of cardiac troponin I (in μg/L) will be used to assess myocardial injury
Measured: 30 days
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)
Measured: 30 days
Assessment of the course of COVID-19 infection
COVID-19 infection will be assessed by inflammatory indices in blood (CRP in mg/L)
Measured: 30 days
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)
Measured: 30 days
Assessment of the course of COVID-19 infection
COVID-19 infection will be assessed by temperature monitoring (in degrees Celsius)
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start29 May 2020
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
Why it stopped: Due to specific inclusion criteria no more subjects could be enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II, parallel, prospective, randomized, double-blind, placebo controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Attikon Hospital
- Responsible party
- Sponsor
- Investigators
- Georgia Kostopanagiotou, MD, Principal investigator, ATTIKON University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348513
- Sponsor's protocol ID
- T3inj-02/ThySupport
- Acronym
- Thy-Support
- Status last verified
- Sep 2021
- First submitted
- 9 Apr 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34151781Pantos 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.
PubMed 32586399
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support)
- ClinicalTrials.gov ID
- NCT04348513
- Acronym / sponsor ID
- Thy-Support / T3inj-02/ThySupport
- Conditions
- Pulmonary Infection, Covid-19
- Keywords
- Covid-19, Pulmonary Infection, T3, Triiodothyronine, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to specific inclusion criteria no more subjects could be enrolled.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.Industry (pharma, biotech, devices)
- Collaborators
- Attikon Hospital
- Study start
- 29 May 2020 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase II, parallel, prospective, randomized, double-blind, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| T3 solution for injection | Experimental | Drug: T3 solution for injectionT3 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). |
| Placebo | Placebo comparator | Drug: PlaceboComposition identical apart from the active substance. Same dosage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T3 solution for injectionFor 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 | T3 solution for injection |
| PlaceboSame as with T3 solution for injection. | Drug | Placebo |
Primary outcome
Assessment of weaning from cardiorespiratory support
Time frame: 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.
26 secondary outcomes
Assessment of hemodynamic status
Time frame: 30 days
Assessment of hemodynamic status
Time frame: 30 days
Assessment of hemodynamic status
Time frame: 30 days
Assessment of hemodynamic status
Time frame: 30 days
Assessment of pulmonary function
Time frame: 30 days
Assessment of pulmonary function
Time frame: 30 days
Assessment of pulmonary function
Time frame: 30 days
Assessment of hepatic function
Time frame: 30 days
Assessment of hepatic function
Time frame: 30 days
Assessment of hepatic function
Time frame: 30 days
Assessment of hepatic function
Time frame: 30 days
Assessment of hepatic function
Time frame: 30 days
Assessment of hepatic function
Time frame: 30 days
Assessment of renal function
Time frame: 30 days
Assessment of renal function
Time frame: 30 days
Assessment of renal function
Time frame: 30 days
Assessment of renal function
Time frame: 30 days
Assessment of cardiac function
Time frame: 30 days
Assessment of cardiac injury
Time frame: 30 days
Assessment of the course of COVID-19 infection
Time frame: 30 days
Assessment of the course of COVID-19 infection
Time frame: 30 days
Assessment of the course of COVID-19 infection
Time frame: 30 days
Assessment of the course of COVID-19 infection
Time frame: 30 days
Assessment of the course of COVID-19 infection
Time frame: 30 days
Assessment of clinical outcome and safety
Time frame: 30 days
Assessment of clinical outcome and safety
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Due to specific inclusion criteria no more subjects could be enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 34151781Pantos 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.
- Derived from this study: PubMed 32586399Pantos 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.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgia Kostopanagiotou, MD principal investigator
ATTIKON University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T3 solution for injection in people with Pulmonary Infection and Covid-19, run by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to specific inclusion criteria no more subjects could be enrolled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of weaning from cardiorespiratory support (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348513, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.