Mineralocorticoid Use in COVID-19 Patients

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05453214

Collaborator

(none)

Enrollment

Location

Arm

6.5

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 ARDS	Drug: Fludrocortisone Acetate 0.1 MG	Phase 3

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

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Fludrocortisone Addition to Dexamethasone in the Management of Hospitalised COVID-19 Patients

Actual Study Start Date :

Dec 4, 2021

Actual Primary Completion Date :

Mar 3, 2022

Actual Study Completion Date :

Jun 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Fludrocortisone Acetate 0.1 MG Fludrocortisone acetate 0.1 mg tablet / 12 hours; dose to be titrated according to response.

Arm

Intervention/Treatment

Experimental: 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

Drug: Fludrocortisone Acetate 0.1 MG

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

Outcome Measures

Primary Outcome Measures

Time to recovery [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

Secondary Outcome Measures

Mortality Rate [28 days]
All-cause mortality rate over 28 days post enrollment.
Length of hospital stay [28 days]
Number of days since enrollment till hospital discharge.
Rate of ICU admission [28 days]
Number of patients who experienced worsening of clinical status necessitating ICU admission.
Mechanical ventilation need [28 days]
Number of patients who needed invasive mechanical ventilation during hospitalisation.
Improvement of lymphopenia [7 days]
Reversal of lymphopenia - measured at days 3 and 7 after initiation of treatment.
Duration of Increased Supplemental Oxygen [28 days]
Number of days counted from enrollment over which the participant requires supplemental oxygen in excess over his/her baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.