Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19
- Conditions
- Coronavirus InfectionPneumonia, Viral
- Interventions
- Drug: Standard-of-care SARS-CoV-2 treatment
- Registration Number
- NCT04826822
- Lead Sponsor
- Chita State Regional Clinical Hospital Number 1
- 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 440
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Spironolactone + Dexamethasone After randomisation (Day 1): Spironolactone \[100 mg 1x/day\] + dexamethasone \[2 mg 2x/day, 12/12h\] Days 2-12\*: Spironolactone \[50 mg 2x/day, 12/12h\] + dexamethasone \[2 mg 2x/day, 12/12h\] Days 13-20: Spironolactone \[25 mg 2x/day, 12/12h\] Days 21-28: Spironolactone \[25 mg 1x/day\] Standard treatment is according to the treatment protocol for 2019-nCoV infection. \*In case of cortisol levels above 100 nmol/L on days 3 and 4, the dexamethasone dose should be increased to 3 mg in the morning and in the evening (total 6 mg per day). Control Standard-of-care SARS-CoV-2 treatment Patients receiving standard-of-care treatment for SARS-CoV-2 infection as regulated by the relevant guidelines of the Ministry of Healthcare of the Russian Federation
- Primary Outcome Measures
Name Time Method Evaluation of the clinical status Day 14 post-randomization Clinical status at day 14 post-randomization defined by a 6-point ordinal scale score (6 being the worst score)
- Secondary Outcome Measures
Name Time Method 28-day all-cause mortality 28 days post-randomization All-cause mortality at 28 days post-randomization
Oxygen-free days 28 days post-randomization The number of days without oxygen support of any type
Invasive mechanical ventilation 28 days post-randomization The number of patients requiring invasive mechanical ventilation during hospitalization and the number of days spent on newly-administered invasive mechanical ventilation
Ventilator-free days 28 days post-randomization The number of days without invasive mechanical ventilation
Time to discharge 28 days post-randomization The number of days from hospitalization to discharge
Length of ICU stay 28 days post-randomization The number of days spent in the intensive care unit
New ICU admission 28 days post-randomization The number of patients requiring transfer to ICU and the number of days spent in the ICU post-transfer
Long-COVID development 60 and 90 days post-admission The number of patients with signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis (Post-COVID-19 syndrome as defined by the relevant NICE guidance)
Evaluation of the clinical status Day 7 post-randomization Clinical status at day 7 post-randomization defined by a 6-point ordinal scale score (6 being the worst score)
Trial Locations
- Locations (1)
Chita State Regional Clinical Hospital Number 1
🇷🇺Chita, Russian Federation