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CompletedNCT05070091ENDO-COVID19Updated Feb 24, 2022

The Impact of Pituitary-thyroid and Pituitary-adrenal Axes Function on COVID-19 Clinical Course.

An observational study in COVID-19, Low Triiodothyronine Syndrome and Adrenal Insufficiency, sponsored by Medical University of Gdansk. Completed at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-24.

Sponsored by Medical University of Gdansk · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study summary

The main focus of the study is the assessment of hormonal function in the course of COVID-19 infection with special regard for trends predicting clinical events defined as primary endpoints of the study.

02

Conditions studied

  • COVID-19
  • Low Triiodothyronine Syndrome
  • Adrenal Insufficiency
  • Subacute Thyroiditis
  • Hypothyroidism
  • Hyperthyroidism

Keywords

  • COVID-19, thyroid, adrenal gland, pituitary, glucocorticoids
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hospitalized patients with PCR-confirmed COVID-19 infection.

Inclusion criteria

  • PCR-confirmed COVID-19 infection
  • volunteers consenting to participate

Exclusion criteria

Exclusion Criteria:

  • no consent
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
180 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Meeting the primary endpoint criteria.

    Primary endpoint is defined as a composite endpoint including death, mechanical ventilation, vasopressor use, noninvasive ventilation, prolonged hospital stay (\>10 days).

    Time frame: Time of hospitalization, typically less than one month.

06

Study locations

2 sites
  • 7 Szpital Marynarki Wojennej
    Gdańsk, Poland
  • Medical University of Gdansk
    Gdańsk, Poland
07

Registry details

Key details

Study ID
NCT05070091
Lead sponsor
Medical University of Gdansk
Collaborators
National Center for Research and Development, Poland
Responsible party
Sponsor
First posted
Oct 6, 2021
Start date
Jan 26, 2021
Primary completion
Dec 1, 2021
Completion
Dec 1, 2021
Last update
Feb 24, 2022

Study contacts

Renata Świątkowska-Stodulska, MD PhD
study director · Medical University of Gdansk
Agata Berlińska, MD
principal investigator · Medical University of Gdansk

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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