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

NCT04348513 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-09-23

No results posted yet for this study

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

Interventions

DRUG

T3 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.

DRUG

Placebo

Same as with T3 solution for injection.

Sponsors & Collaborators

  • Attikon Hospital

    collaborator OTHER

  • Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

    lead INDUSTRY

Principal Investigators

  • Georgia Kostopanagiotou, MD · ATTIKON University General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2021-04-19
Completion
2021-04-19

Countries

  • Greece

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04348513 on ClinicalTrials.gov