COVID-19ENDO-COVID19NCT05070091
The Impact of Pituitary-thyroid and Pituitary-adrenal Axes Function on COVID-19 Clinical Course.
An observational study of COVID-19 and Low Triiodothyronine Syndrome, run by Medical University of Gdansk at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Low Triiodothyronine Syndrome, Adrenal Insufficiency
- How many people
- 180 participants
- Where
- 2 sitesPoland
- Study dates
- 26 Jan 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with PCR-confirmed COVID-19 infection.
Who may be able to join
- PCR-confirmed COVID-19 infection
- volunteers consenting to participate
Who cannot join
- no consent
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
7 Szpital Marynarki Wojennej
Gdansk
Medical University of Gdansk
Gdansk
About this study
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.
- Conditions
- COVID-19, Low Triiodothyronine Syndrome, Adrenal Insufficiency, Subacute Thyroiditis, Hypothyroidism, Hyperthyroidism
- Keywords
- COVID-19, thyroid, adrenal gland, pituitary, glucocorticoids
- Medical subject headings
- COVID-19, Euthyroid Sick Syndromes, Adrenal Insufficiency, Thyroiditis, Subacute, Hypothyroidism, Hyperthyroidism, Thyroid Diseases, Pituitary Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Time of hospitalization, typically less than one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start26 Jan 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
- Investigators
- Renata Świątkowska-Stodulska, MD PhD, Study director, Medical University of GdanskAgata Berlińska, MD, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070091
- Sponsor's protocol ID
- ENDO-COVID19
- Acronym
- ENDO-COVID19
- Status last verified
- Feb 2022
- First submitted
- 4 Oct 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pituitary-thyroid and Pituitary-adrenal Axes Function on COVID-19 Clinical Course.
- ClinicalTrials.gov ID
- NCT05070091
- Acronym / sponsor ID
- ENDO-COVID19 / ENDO-COVID19
- Conditions
- COVID-19, Low Triiodothyronine Syndrome, Adrenal Insufficiency, Subacute Thyroiditis, Hypothyroidism, Hyperthyroidism
- Keywords
- COVID-19, thyroid, adrenal gland, pituitary, glucocorticoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with PCR-confirmed COVID-19 infection.
Key inclusion criteria (2 listed)
- PCR-confirmed COVID-19 infection
- volunteers consenting to participate
Key exclusion criteria (1 listed)
- no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Meeting the primary endpoint criteria.
Time frame: Time of hospitalization, typically less than one month.
Primary endpoint is defined as a composite endpoint including death, mechanical ventilation, vasopressor use, noninvasive ventilation, prolonged hospital stay (>10 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Świątkowska-Stodulska, MD PhD study director
Medical University of Gdansk
Agata Berlińska, MD principal investigator
Medical University of Gdansk
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Low Triiodothyronine Syndrome, run by Medical University of Gdansk at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meeting the primary endpoint criteria. (time frame: Time of hospitalization, typically less than one month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.