Mineralocorticoid Use in COVID-19 Patients

• Status: Completed
• Trial end date: 2022-06-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Fludrocortisone

Criteria

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.