NCT04348513: Thy-Support

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

Terminated Phase 2 Last updated 23 September 2021

What this trial tests

Phase 2 trial testing T3 solution for injection in Pulmonary Infection in 5 participants. Terminated before completion.

Timeline

29 May 2020

Primary endpoint
19 April 2021

19 April 2021

Quick facts

Lead sponsor	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	5
Start date	29 May 2020
Primary completion	19 April 2021
Estimated completion	19 April 2021
Sites	1 location across Greece

Drugs / interventions tested

• T3 solution for injection — full drug profile →
• Placebo

Conditions studied

• Pulmonary Infection — all drugs for Pulmonary Infection →
• Covid-19 — all drugs for Covid-19 →

Sponsor

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. — full company profile →

Who can join

18 and older, any sex, with Pulmonary Infection or Covid-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
   Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
2. Potential Interaction Between SARS-CoV-2 and Thyroid: A Review.
   Chen W, Tian Y, Li Z, Zhu J, et al · · 2021 · cited 75× · PMID 33543236 · DOI 10.1210/endocr/bqab004
3. Potential Therapeutic Options for COVID-19: Current Status, Challenges, and Future Perspectives.
   Sarkar C, Mondal M, Torequl Islam M, Martorell M, et al · · 2020 · cited 64× · PMID 33041814 · DOI 10.3389/fphar.2020.572870
4. COVID-19 and thyroid function: What do we know so far?
   Rossetti CL, Cazarin J, Hecht F, Beltrão FEL, et al · · 2022 · cited 49× · PMID 36601011 · DOI 10.3389/fendo.2022.1041676
5. SARS-CoV-2: Emerging Role in the Pathogenesis of Various Thyroid Diseases.
   Murugan AK, Alzahrani AS. · · 2021 · cited 42× · PMID 34853527 · DOI 10.2147/jir.s332705
6. Primed for global coronavirus pandemic: Emerging research and clinical outcome.
   Ahamad S, Branch S, Harrelson S, Hussain MK, et al · · 2021 · cited 25× · PMID 33070079 · DOI 10.1016/j.ejmech.2020.112862
7. Triiodothyronine for the treatment of critically ill patients with COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial.
   Pantos C, Kostopanagiotou G, Armaganidis A, Trikas A, et al · · 2020 · cited 25× · PMID 32586399 · DOI 10.1186/s13063-020-04474-0
8. Gene signature and immune cell profiling by high-dimensional, single-cell analysis in COVID-19 patients, presenting Low T3 syndrome and coexistent hematological malignancies.
   Sciacchitano S, De Vitis C, D'Ascanio M, Giovagnoli S, et al · · 2021 · cited 20× · PMID 33794925 · DOI 10.1186/s12967-021-02805-6