NCT05070091

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

October 4, 2021

Last Update Submit

February 7, 2022

Conditions

COVID-19Low Triiodothyronine SyndromeAdrenal InsufficiencySubacute ThyroiditisHypothyroidismHyperthyroidism

Keywords

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

Outcome Measures

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 of hospitalization, typically less than one month.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients with PCR-confirmed COVID-19 infection.

You may qualify if:

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

You may not qualify if:

  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

7 Szpital Marynarki Wojennej

Gdansk, Poland

Location

Medical University of Gdansk

Gdansk, Poland

Location

MeSH Terms

Conditions

COVID-19Euthyroid Sick SyndromesAdrenal InsufficiencyThyroiditis, SubacuteHypothyroidismHyperthyroidismThyroid DiseasesPituitary Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesEndocrine System DiseasesAdrenal Gland DiseasesThyroiditisHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Renata Świątkowska-Stodulska, MD PhD

    Medical University of Gdansk

    STUDY DIRECTOR

  • Agata Berlińska, MD

    Medical University of Gdansk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 6, 2021

Study Start

January 26, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 24, 2022

Record last verified: 2022-02

Locations

PL(2)