Mineralocorticoid Use in COVID-19 Patients
Safety and Efficacy of Fludrocortisone Addition to Dexamethasone in the Management of Hospitalised COVID-19 Patients
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 covid19
Started Dec 2021
1 active site
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
December 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedFirst Submitted
Initial submission to the registry
July 9, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedJuly 12, 2022
July 1, 2022
3 months
July 9, 2022
July 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
28 days
Secondary Outcomes (6)
Mortality Rate
28 days
Length of hospital stay
28 days
Rate of ICU admission
28 days
Mechanical ventilation need
28 days
Improvement of lymphopenia
7 days
- +1 more secondary outcomes
Study Arms (1)
Fludrocortisone arm
EXPERIMENTAL10 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
Interventions
Fludrocortisone acetate 0.1 mg tablet / 12 hours; dose to be titrated according to response.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, Abbasia, 11591, Egypt
Related Publications (5)
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.
PMID: 33737961BACKGROUNDBauer 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.
PMID: 8324299BACKGROUNDWang 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.
PMID: 31994742BACKGROUNDSzymanski 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.
PMID: 19896738BACKGROUNDGossain 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.
PMID: 3518450BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad S Zeafan
Alazhar allergy and immunology center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2022
First Posted
July 12, 2022
Study Start
December 4, 2021
Primary Completion
March 3, 2022
Study Completion
June 20, 2022
Last Updated
July 12, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Starting 6 months after article publication and the data will be made accessible for up to 24 months
- Access Criteria
- Access to trial IPD can be requested by qualified researchers, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact muhammadsaberz@gmail.com
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.