Spironolactone on COVID-19 patients.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/03/031721
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 room air but maintaining SpO2 of >94% on VenturiMask / Non
rebreathing mask
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>2.To determine the effect of the medication on Von Willebrand Factor, Angiotensin II, aldosterone and D-Dimer Levels.Timepoint: Baseline <br/ ><br>Day 1 <br/ ><br>Day 4 <br/ ><br>Day 7
- Secondary Outcome Measures
Name Time Method 1. To determine if the medication has a beneficial effect on the classic cough <br/ ><br>experienced by many patients with SARS_CoV-2. <br/ ><br>2. To determine the Duration (days) of oxygen use and oxygen-free days <br/ ><br>3. To determine the effect of the medications on plasma corticosteroids levels as a <br/ ><br>measure of suppression of the production of cortisol and blockade of the <br/ ><br>Mineralocorticoid ReceptorTimepoint: Baseline <br/ ><br>Day 1 <br/ ><br>Day 4 <br/ ><br>Day 7