Hormones after COVID-19
| ISRCTN | ISRCTN15615697 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15615697 |
| IRAS number | 288153 |
| Secondary identifying numbers | IRAS 288153 |
- Submission date
- 20/01/2021
- Registration date
- 31/01/2021
- Last edited
- 31/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The ongoing COVID-19 pandemic remains a significant public health concern. However, it is now recognised that following COVID-19, patients may experience symptoms such as fatigue. There is little data on how many people experience these symptoms and their duration. Commonly, tiredness may be related to hormone (endocrine) dysfunction in patients without COVID-19. However, the frequency of endocrine dysfunction after COVID-19 is unknown. Not only are coronaviruses associated with adrenal gland dysfunction, but other endocrine glands may also be affected. Patients with COVID-19 have been described as displaying abnormalities in thyroid hormones and male reproductive hormones.
In summary, the full hormone effects of COVID-19 are currently unknown. This study attempts to fully interrogate the endocrine system, so that participants can receive necessary treatment, and to provide further information to guide the clinician when caring for patients diagnosed with COVID-19.
Who can participate?
Men and women aged 18 and over who have been tested for COVID-19 at least 3 months ago. Individuals interested in taking part will be contacted by telephone and asked a series of questions to confirm their eligibility before attending for their research study visit.
What does the study involve?
The study consists of an initial 2-hour visit that takes place at least 3 months after initial symptoms, with up to three further study visits over the course of the year at 3-monthly intervals. During this appointment, participants will be asked several questions regarding their medical history, undergo a physical examination, followed by some blood tests, including a particular dynamic hormone test, called a Short Synacthen test, that assesses the function of the adrenal glands.
What are the possible benefits and risks of participating?
Taking part in the study will provide information regarding the participant’s hormone system including the critical hypothalamic-pituitary-adrenal axis. Participation may identify hormonal problems that would have otherwise been undetected. This study may also help guide endocrine surveillance of these patients on a global scale to reduce illness and death.
Venepuncture for blood tests is a routine, well-tolerated and safe procedure, and will only be carried out by experienced physicians and nursing staff. The short synacthen test is an established dynamic function test commonly used in routine endocrine care, with millions globally as part of routine endocrine investigations, and is well tolerated by patients. Synacthen is a synthetic form of a naturally occurring hormone and is not known to have any specific side-effects. However, to minimise any risk to participants, only experienced clinical personnel will undertake these tasks. Furthermore, participants will be monitored throughout the whole study visit by senior clinical staff.
Where is the study run from?
Charing Cross Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2020 to October 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Waljit Dhillo
w.dhillo@imperial.ac.uk
imperial.hormonescovid19@nhs.net
Contact information
Scientific
Section of Endocrinology and Investigative Medicine
Imperial College London
6th Floor Commonwealth Building
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 (0)20 3313 3242 |
|---|---|
| w.dhillo@imperial.ac.uk |
Public
Imperial College London
6th Floor Commonwealth Building
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 (0)20 3313 3242 |
|---|---|
| sophie.clarke@imperial.ac.uk |
Study information
| Study design | Physiological observational prospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Prospective observational study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Endocrinopathies post COVID-19 |
| Study hypothesis | It is known that some coronaviruses can affect the endocrine system, such as the adrenal glands, some weeks to months after initial infection. However, it is yet unknown whether COVID-19 affects the endocrine system. |
| Ethics approval(s) | Approved 16/09/2020, London Bridge Research Ethics Committee (Ground Floor, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)207 104 8019; londonbridge.rec@hra.nhs.uk), REC ref: 20/HRA/4110 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | Patients who have had a test for COVID-19 will be invited to take part in the study. During their clinical research visit, a medical history will be taken, a physical examination performed and blood tests to assess the endocrine system will be completed. A short synacthen test will also be carried out to assess adrenal function. |
| Intervention type | Other |
| Primary outcome measure | The proportion of patients with confirmed COVID-19 who show evidence of adrenal insufficiency on a short Synacthen test ≥3 months following their presentation with suspected COVID-19 |
| Secondary outcome measures | Secondary outcome measures will include the following: 1. Proportion of patients previously diagnosed with COVID-19 with evidence of adrenal insufficiency on their first short Synacthen test who show adrenal recovery at subsequent visits at months 3, 6 and 9 months after initial study visit, whereby the first study visit takes place at least 3 months after initial presentation 2. Proportion of patients previously diagnosed with COVID-19 with evidence of other hormone disturbances (including thyroid and reproductive hormones) measured using serum thyroid function tests and serum reproductive hormone tests (LH, FSH, testosterone and oestradiol) at least 3 months after initial presentation |
| Overall study start date | 16/09/2020 |
| Overall study end date | 16/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 70 |
| Participant inclusion criteria | Patients aged ≥18 years with a clinical suspicion of COVID-19 infection will be invited to take part in the study. Those with a diagnosis of COVID-19, either on the basis of a positive result from real-time RT-PCR testing of a nasopharyngeal swab, or based on diagnostic clinical and radiological findings will be included in the COVID-19 group. |
| Participant exclusion criteria | 1. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the participant. 2. History of blood donation within the past 3 months, or the intention to do so within 3 months of completing the study 3. Being pregnant or breastfeeding |
| Recruitment start date | 13/10/2020 |
| Recruitment end date | 17/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Fulham Palace Road
London
W6 8RF
United Kingdom
Sponsor information
University/education
Joint Research and Compliance Office
Imperial College London and Imperial College Healthcare NHS Trust
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 (0)207 594 9459 |
|---|---|
| becky.ward@imperial.ac.uk | |
| Website | http://www.imperial.ac.uk |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 16/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Additional study documents including study protocol are available on request 2. The results of the study will be disseminated to participants. Furthermore, results will be disseminated to the scientific community by means of publication in peer-reviewed literature and presentation at national and international meetings. |
| IPD sharing plan | All participants have been requested to provide consent for data sharing. Where this consent has been provided, anonymised datasets generated during the current study will be available upon request from Prof. Waljit Dhillo (w.dhillo@imperial.ac.uk) upon completion and publication of the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/07/2021 | 31/10/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
31/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
17/11/2021: The recruitment end date has been changed from 16/08/2022 to 17/11/2021.
26/01/2021: Trial's existence confirmed by London Bridge Research Ethics Committee.
