Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19

Chita State Regional Clinical Hospital Number 1440 enrolled

Overview

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. However, a proportion of patients, especially elderly men or patients with comorbidities, are at risk of developing acute respiratory distress syndrome (ARDS). ARDS, alongside clotting abnormalities, is known to be a major contributor to SARS-CoV-2-related mortality and admission to intensive care units, with evidenced effective preventative treatment options lacking. In this study, the investigators test a novel hypothesis that the use of a combination of spironolactone and dexamethasone at low doses will improve the clinical progression of the infection evaluated by the 6-point ordinal scale in patients with moderate and severe disease by blocking exocytosis of the Weibel-Palade bodies from endothelial cells.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

440

Conditions

Coronavirus Infection Pneumonia, Viral

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Criteria: * 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

Outcomes

Primary Outcomes

Evaluation of the clinical status

Clinical status at day 14 post-randomization defined by a 6-point ordinal scale score (6 being the worst score)

Time frame: Day 14 post-randomization