COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04826822

Sergey Lukyanov, MD

lukyanov-sergei@mail.ru

2021-04-01

Unknown

RCT

Randomized

Parallel

Open label

single-center

Treatment

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)

- 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

2

Chita State Regional Clinical Hospital Number 1

18

100

Russia

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

440

Evaluation of the clinical status

None

Phase 3

[{"arm_notes": "", "treatment_id": 1484, "treatment_name": "Dexamethasone+spironolactone", "treatment_type": "Corticosteroids+cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]