Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection

NCT04348513 | Terminated Phase 2 DMC

• 1 other identifier: T3inj-02/ThySupport
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Infection; Covid-19

Keywords

Covid-19; Pulmonary Infection; T3; Triiodothyronine; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (26)

• Assessment of hemodynamic status

  30 days

• Assessment of hemodynamic status

  30 days

• Assessment of hemodynamic status

  30 days

• Assessment of hemodynamic status

  30 days

• Assessment of pulmonary function

  30 days

Study Arms (2)

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).

Drug: T3 solution for injection

Placebo

PLACEBO COMPARATOR

Composition identical apart from the active substance. Same dosage.

Drug: Placebo

Interventions

T3 solution for injection DRUG

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.

T3 solution for injection

Placebo DRUG

Same as with T3 solution for injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.: lead
• Attikon Hospital: collaborator

Study Sites (1)

Attikon University General Hospital

Haidari/Athens, 12462, Greece

Location

Related Publications (2)

• 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.

  PMID: 34151781 DERIVED

• 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.

  PMID: 32586399 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Injections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Georgia Kostopanagiotou, MD

  ATTIKON University General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase II, parallel, prospective, randomized, double-blind, placebo controlled trial

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 16, 2020
• Study Start: May 29, 2020
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)