COVID-19Phase 3NCT05453214
Mineralocorticoid Use in COVID-19 Patients
A Phase 3 study testing Fludrocortisone Acetate 0.1 MG in people with COVID-19 and ARDS, run by Ain Shams University at 1 site in Egypt.
Trial summary
There is a considerable variability in aldosterone levels between individuals, and this may explain the wide variability in disease severity among those infected so we designed a pilot study to test for the safety and efficacy of fludrocortisone addition to standard of care in hospitalised COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Fludrocortisone Acetate 0.1 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Dec 2021to 20 Jun 2022
- Phase
- Phase 3
- 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
Who may be able to join
- Male and non-pregnant female patients 18 years of age or older
- Diagnosed with COVID-19 pneumonia as per local guidelines
- Oxygen saturation (SaO2) of 93 % or less while they were breathing ambient air.
Who cannot join
- A physician decision that involvement in the trial will not be in the patient's best interest, presence of any condition that would not allow the protocol to be followed safely.
- known allergy or hypersensitivity to fludrocortisone.
- known severe liver or kidney disease, uncontrolled hypertension, diabetes mellitus and peptic ulcer disease.
- Hypokalemia (serum potassium of less than 3.5 mEq/L)
- Use of medications that are contraindicated with fludrocortisone and that could not be replaced or stopped during the trial period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Fludrocortisone Addition to Dexamethasone in the Management of Hospitalised COVID-19 Patients
There is a considerable variability in aldosterone levels between individuals, and this may explain the wide variability in disease severity among those infected so we designed a pilot study to test for the safety and efficacy of fludrocortisone addition to standard of care in hospitalised COVID-19 patients.
Read the detailed description
Many studies have shown involvement of renin-angiotensin-aldosterone system (RAAS) in pathophysiology of COVID-19. There is a considerable variability between people infected with SARS-COV-2 virus in terms of severity. At pathophysiological level there are variable degrees of increased capillary permeability with resultant fluid leak. We hypothesize that the physiological response to overcome this fluid leak mainly involves stimulation of mineralocorticoid (aldosterone) pathway. Hence; those with defective mineralocorticoid response are at high risk for disease complications.
Aldosterone secretion capacity is affected by many factors whether physiological (age, sex, ethnicity and pregnancy) or pathological (e.g. smoking); this is reflected in wide differences (regarding aldosterone levels) between groups of people depending on these factors.
These variations in mineralocorticoid capacity between groups of people may explain why some certain groups are at high risk for severe disease while others are at a lower risk.
So we designed this pilot study to assess safety and efficacy of mineralocorticoid, in the form of fludrocortisone, as a potential treatment for COVID-19 by its addition to dexamethasone in hospitalized COVID-19 patients.
- Being tested
- Fludrocortisone Acetate 0.1 MG
- Keywords
- fludrocortisone, mineralocorticoid, COVID-19, ARDS, Aldosterone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludrocortisone Acetate 0.1 MGDrug
Fludrocortisone acetate 0.1 mg tablet / 12 hours; dose to be titrated according to response.
| Study group | Role | What they receive |
|---|---|---|
| Fludrocortisone arm | Experimental | 10 hospitalised COVID-19 patients meeting inclusion criteria will receive fludrocortisone 0.1 mg tablets in addition to dexamethasone 6 mg / 24 hours and standard care Receives: Drug: Fludrocortisone Acetate 0.1 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery
The first day, during the 28 days after enrollment, on which a patient met the criteria for category 1 or 2 on the eight-category ordinal scale
Measured: 28 days
Secondary outcomes (6)
Mortality Rate
All-cause mortality rate over 28 days post enrollment.
Measured: 28 days
Length of hospital stay
Number of days since enrollment till hospital discharge.
Measured: 28 days
Rate of ICU admission
Number of patients who experienced worsening of clinical status necessitating ICU admission.
Measured: 28 days
Mechanical ventilation need
Number of patients who needed invasive mechanical ventilation during hospitalisation.
Measured: 28 days
Improvement of lymphopenia
Reversal of lymphopenia - measured at days 3 and 7 after initiation of treatment.
Measured: 7 days
Duration of Increased Supplemental Oxygen
Number of days counted from enrollment over which the participant requires supplemental oxygen in excess over his/her baseline.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start4 Dec 2021
- Primary completion3 Mar 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad S Zeafan, Principal investigator, Alazhar allergy and immunology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453214
- Sponsor's protocol ID
- FMASU R111c/2021
- Status last verified
- Jul 2022
- First submitted
- 9 Jul 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in COVID-19. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Coto E, Avanzas P, Gomez J. The Renin-Angiotensin-Aldosterone System and Coronavirus Disease 2019. Eur Cardiol. 2021 Mar 9;16:e07. doi: 10.15420/ecr.2020.30. eCollection 2021 Feb.
PubMed 33737961Bauer JH. Age-related changes in the renin-aldosterone system. Physiological effects and clinical implications. Drugs Aging. 1993 May-Jun;3(3):238-45. doi: 10.2165/00002512-199303030-00005.
PubMed 8324299Wang W, Tang J, Wei F. Updated understanding of the outbreak of 2019 novel coronavirus (2019-nCoV) in Wuhan, China. J Med Virol. 2020 Apr;92(4):441-447. doi: 10.1002/jmv.25689. Epub 2020 Feb 12.
PubMed 31994742Szymanski P, Klisiewicz A, Lubiszewska B, Lipczynska M, Kowalski M, Janas J, Hoffman P. Gender differences in angiotensin II and aldosterone secretion in patients with pressure overloaded systemic right ventricles are similar to those observed in systemic arterial hypertension. Int J Cardiol. 2011 Mar 17;147(3):366-70. doi: 10.1016/j.ijcard.2009.09.535. Epub 2009 Nov 7.
PubMed 19896738Gossain VV, Sherma NK, Srivastava L, Michelakis AM, Rovner DR. Hormonal effects of smoking--I: Effects on plasma renin activity. Am J Med Sci. 1986 May;291(5):321-4. doi: 10.1097/00000441-198605000-00006.
PubMed 3518450
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Fludrocortisone Addition to Dexamethasone in the Management of Hospitalised COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05453214
- Acronym / sponsor ID
- FMASU R111c/2021
- Keywords
- fludrocortisone, mineralocorticoid, COVID-19, ARDS, Aldosterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 4 Dec 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 12 Jul 2022 (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.
There is a considerable variability in aldosterone levels between individuals, and this may explain the wide variability in disease severity among those infected so we designed a pilot study to test for the safety and efficacy of fludrocortisone addition to standard of care in hospitalised COVID-19 patients.
Detailed description
Many studies have shown involvement of renin-angiotensin-aldosterone system (RAAS) in pathophysiology of COVID-19. There is a considerable variability between people infected with SARS-COV-2 virus in terms of severity. At pathophysiological level there are variable degrees of increased capillary permeability with resultant fluid leak. We hypothesize that the physiological response to overcome this fluid leak mainly involves stimulation of mineralocorticoid (aldosterone) pathway. Hence; those with defective mineralocorticoid response are at high risk for disease complications.
Aldosterone secretion capacity is affected by many factors whether physiological (age, sex, ethnicity and pregnancy) or pathological (e.g. smoking); this is reflected in wide differences (regarding aldosterone levels) between groups of people depending on these factors.
These variations in mineralocorticoid capacity between groups of people may explain why some certain groups are at high risk for severe disease while others are at a lower risk.
So we designed this pilot study to assess safety and efficacy of mineralocorticoid, in the form of fludrocortisone, as a potential treatment for COVID-19 by its addition to dexamethasone in hospitalized COVID-19 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fludrocortisone arm | Experimental | Drug: Fludrocortisone Acetate 0.1 MG10 hospitalised COVID-19 patients meeting inclusion criteria will receive fludrocortisone 0.1 mg tablets in addition to dexamethasone 6 mg / 24 hours and standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and non-pregnant female patients 18 years of age or older
- Diagnosed with COVID-19 pneumonia as per local guidelines
- Oxygen saturation (SaO2) of 93 % or less while they were breathing ambient air.
Key exclusion criteria (5 listed)
- A physician decision that involvement in the trial will not be in the patient's best interest, presence of any condition that would not allow the protocol to be followed safely.
- known allergy or hypersensitivity to fludrocortisone.
- known severe liver or kidney disease, uncontrolled hypertension, diabetes mellitus and peptic ulcer disease.
- Hypokalemia (serum potassium of less than 3.5 mEq/L)
- Use of medications that are contraindicated with fludrocortisone and that could not be replaced or stopped during the trial period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fludrocortisone Acetate 0.1 MGFludrocortisone acetate 0.1 mg tablet / 12 hours; dose to be titrated according to response. | Drug | Fludrocortisone arm |
Primary outcome
Time to recovery
Time frame: 28 days
The first day, during the 28 days after enrollment, on which a patient met the criteria for category 1 or 2 on the eight-category ordinal scale
6 secondary outcomes
Mortality Rate
Time frame: 28 days
Length of hospital stay
Time frame: 28 days
Rate of ICU admission
Time frame: 28 days
Mechanical ventilation need
Time frame: 28 days
Improvement of lymphopenia
Time frame: 7 days
Duration of Increased Supplemental Oxygen
Time frame: 28 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 12 Jul 2022.
- Background: PubMed 33737961Coto E, Avanzas P, Gomez J. The Renin-Angiotensin-Aldosterone System and Coronavirus Disease 2019. Eur Cardiol. 2021 Mar 9;16:e07. doi: 10.15420/ecr.2020.30. eCollection 2021 Feb.
- Background: PubMed 8324299Bauer JH. Age-related changes in the renin-aldosterone system. Physiological effects and clinical implications. Drugs Aging. 1993 May-Jun;3(3):238-45. doi: 10.2165/00002512-199303030-00005.
- Background: PubMed 31994742Wang W, Tang J, Wei F. Updated understanding of the outbreak of 2019 novel coronavirus (2019-nCoV) in Wuhan, China. J Med Virol. 2020 Apr;92(4):441-447. doi: 10.1002/jmv.25689. Epub 2020 Feb 12.
- Background: PubMed 19896738Szymanski P, Klisiewicz A, Lubiszewska B, Lipczynska M, Kowalski M, Janas J, Hoffman P. Gender differences in angiotensin II and aldosterone secretion in patients with pressure overloaded systemic right ventricles are similar to those observed in systemic arterial hypertension. Int J Cardiol. 2011 Mar 17;147(3):366-70. doi: 10.1016/j.ijcard.2009.09.535. Epub 2009 Nov 7.
- Background: PubMed 3518450Gossain VV, Sherma NK, Srivastava L, Michelakis AM, Rovner DR. Hormonal effects of smoking--I: Effects on plasma renin activity. Am J Med Sci. 1986 May;291(5):321-4. doi: 10.1097/00000441-198605000-00006.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in COVID-19. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Muhammad S Zeafan principal investigator
Alazhar allergy and immunology center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fludrocortisone Acetate 0.1 MG in people with COVID-19 and ARDS, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 5 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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to recovery (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05453214, which also lists 5 linked publications.
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 12 Jul 2022.