Mineralocorticoid Use in COVID-19 Patients

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: COVID-19; ARDS

Treatments: Drug: Fludrocortisone Acetate 0.1 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05453214

FMASU R111c/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Fludrocortisone arm

Experimental group

Description:

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

Treatment:

Drug: Fludrocortisone Acetate 0.1 MG