Mineralocorticoid Use in COVID-19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-04

Study Completion Date

2022-06-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 ARDS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fludrocortisone arm

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

Group Type EXPERIMENTAL

Fludrocortisone Acetate 0.1 MG

Intervention Type DRUG

Fludrocortisone acetate 0.1 mg tablet / 12 hours; dose to be titrated according to response.

Interventions

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Fludrocortisone Acetate 0.1 MG

Fludrocortisone acetate 0.1 mg tablet / 12 hours; dose to be titrated according to response.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No