Covid19 Clinical Trial - Mineralocorticoid Use in COVID-19 Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05453214
Study type	Interventional
Source	Ain Shams University
Contact
Status	Completed
Phase	Phase 3
Start date	December 4, 2021
Completion date	June 20, 2022

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT06065033` - Exercise Interventions in Post-acute Sequelae of Covid-19	N/A
Completed	`NCT06267534` - Mindfulness-based Mobile Applications Program	N/A
Completed	`NCT05047601` - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection	Phase 2/Phase 3
Recruiting	`NCT05323760` - Functional Capacity in Patients Post Mild COVID-19	N/A
Recruiting	`NCT04481633` - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection	N/A
Completed	`NCT04537949` - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults	Phase 1/Phase 2
Completed	`NCT04612972` - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru	Phase 3
Recruiting	`NCT05494424` - Cognitive Rehabilitation in Post-COVID-19 Condition	N/A
Active, not recruiting	`NCT06039449` - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2	Phase 3
Enrolling by invitation	`NCT05589376` - You and Me Healthy
Completed	`NCT05158816` - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting	`NCT04341506` - Non-contact ECG Sensor System for COVID19
Completed	`NCT04384445` - Zofin (Organicell Flow) for Patients With COVID-19	Phase 1/Phase 2
Completed	`NCT04512079` - FREEDOM COVID-19 Anticoagulation Strategy	Phase 4
Completed	`NCT05975060` - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.	Phase 2/Phase 3
Active, not recruiting	`NCT05542862` - Booster Study of SpikoGen COVID-19 Vaccine	Phase 3
Withdrawn	`NCT05621967` - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation	N/A
Terminated	`NCT05487040` - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease	Phase 1
Terminated	`NCT04498273` - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80	Phase 3
Active, not recruiting	`NCT06033560` - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure