Last updated: March 31, 2021
Sponsor: Chita State Regional Clinical Hospital Number 1
Overall Status: Active - Recruiting
Phase
3
Condition
Corona Virus
Pneumonia
Common Cold
Treatment
N/AClinical Study ID
NCT04826822
SPII_1789461
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
Exclusion Criteria:
- Women of childbearing age without a negative urine pregnancy test, currently pregnantor breastfeeding women;
- Severe heart failure (NYHA4), severe renal failure (eGFR < 30 ml/min/1.73 m2), severeliver 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 anddexamethasone)
- Renal dialysis
- Severe uncontrolled diabetes mellitus
- Patient receiving one of the following medications that cannot be substituted over thetrial duration: ACE inhibitors, amiloride, eplerenone, cortisone acetate, potassiumcanrenoate, triamterene
Study Design
Total Participants: 440
Study Start date:
February 24, 2021
Estimated Completion Date:
September 02, 2021
Connect with a study center
Chita State Regional Clinical Hospital Number 1
Chita, 672039
Russian FederationActive - Recruiting
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