Mineralocorticoid Use in COVID-19 Patients

July 9, 2022 updated by: Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 11591
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery
Time Frame: 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
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Muhammad S Zeafan, Alazhar allergy and immunology center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2021

Primary Completion (Actual)

March 3, 2022

Study Completion (Actual)

June 20, 2022

Study Registration Dates

First Submitted

July 9, 2022

First Submitted That Met QC Criteria

July 9, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 9, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R111c/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

Starting 6 months after article publication and the data will be made accessible for up to 24 months

IPD Sharing 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

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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