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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

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 180 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Medical University of Gdansk is the lead sponsor of 133 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no consent
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
180 participants (actual)
Patient registry
No
06

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.

07

Study locations

2 sites
  • 7 Szpital Marynarki Wojennej
    Gdańsk, Poland
  • Medical University of Gdansk
    Gdańsk, Poland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2021 to primary completion in Dec 2021, 10 months.

Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 10 months is below that.

Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2021
First posted
Oct 6, 2021
StartActual
Jan 26, 2021
Primary completionActual
Dec 1, 2021
CompletionActual
Dec 1, 2021
Last update
Feb 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05070091
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 ↗

Not currently enrolling

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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Discussion

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