Status:
UNKNOWN
Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19
Lead Sponsor:
Chita State Regional Clinical Hospital Number 1
Conditions:
Coronavirus Infection
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) is a rapidly spreading infection of the respiratory tract. Most infected patients have either asymptomatic disease or mild symptoms. Ho...
Eligibility Criteria
Inclusion
- Age 18 years or above;
- Signed informed consent;
- PCR-confirmed diagnosis of SARS-CoV-2 infection
- Presenting with moderate-to-severe disease (scores 4-6 on WHO ordinal scale)
Exclusion
- Women of childbearing age without a negative urine pregnancy test, currently pregnant or breastfeeding women;
- Severe heart failure (NYHA4), severe renal failure (eGFR \< 30 ml/min/1.73 m2), severe liver failure (ALT/AST ratio \> 5 norms), severe anemia (haemoglobin \< 30 g/l)
- Participating in another clinical trial
- Severe electrolyte imbalance (hyperkalemia \> 5.0 mmol/l, hyponatremia \< 120 mmol/l)
- Hypersensitivity or contraindications to the study drugs (spironolactone and dexamethasone)
- Renal dialysis
- Severe uncontrolled diabetes mellitus
- Patient receiving one of the following medications that cannot be substituted over the trial duration: ACE inhibitors, amiloride, eplerenone, cortisone acetate, potassium canrenoate, triamterene
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 2 2021
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04826822
Start Date
February 24 2021
End Date
September 2 2021
Last Update
April 1 2021
Active Locations (1)
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1
Chita State Regional Clinical Hospital Number 1
Chita, Russia, 672039