Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Spironolactone: Spironolactone 50mg on day 1 followed by 25mg till day 21
Route Oral
Frequency OD
Control Intervention1: Dexamethasone and Standard of care.: Dexamethasone, Spironolact
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed COVID-19 by RT PCR test Hospitalized Non ventilated patients with oxygen by mask or nasal prongs (WHO Ordinal Scale 4: Appendix 1) SpO2 94% on VenturiMask / Non rebreathing mask
Exclusion criteria
Exclusion criteria: Participation in another clinical trial of an investigational medicinal product Known hypersensitivity to the IMP Significant electrolyte disturbance (Hyperkalemia: K+ >5.0 mmol/L) Patient currently receiving potassium sparing diuretics that cannot be reasonably withheld • Acute renal insufficiency • In the Investigatorâ??s opinion, patient is unwilling or unable to comply with drug administration plan, laboratory tests or other study procedures. • Pregnant or lactating patient • Patients on the following drugs : ACE inhibitors, Amiloride, Hydrocortisone, Prednisolone, Methylprednisolone, Triamterene
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The time to recover, defined as the first day, during the 28 days after enrollment, on which a patient met the criteria for category 1,2, 0r 3 WHO ordinal scale. 2.To determine the effect of the medication on Von Willebrand Factor, Angiotensin II, aldosterone and D-Dimer Levels.Timepoint: Baseline Day 1 Day 4 Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine if the medication has a beneficial effect on the classic cough experienced by many patients with SARS_CoV-2. 2. To determine the Duration (days) of oxygen use and oxygen-free days 3. To determine the effect of the medications on plasma corticosteroids levels as a measure of suppression of the production of cortisol and blockade of the Mineralocorticoid ReceptorTimepoint: Baseline Day 1 Day 4 Day 7 | — |
Countries
India
Contacts
Public ContactDr Bharti Wadhwa
Maulana Azad Medical College
Outcome results
None listed