Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19

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/A

Clinical Study ID

NCT04826822
SPII_1789461
  • Ages > 18
  • All Genders

Study 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. 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.

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 Federation

    Active - Recruiting

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