Coronavirus Infection, Pneumonia, Viral
Conditions
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.
Interventions
DRUGSpironolactone + Dexamethasone
Low doses of orally administered spironolactone and dexamethasone
DRUGStandard-of-care SARS-CoV-2 treatment
Standard-of-care SARS-CoV-2 treatment administered according to the local guidelines
Sponsors
Chita State Regional Clinical Hospital Number 1
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in classic cough score | 28 days post-randomization | Change in classic cough score measured daily in hospitalized patients |
| Radiological abnormalities | 28 days post-randomization | Occurrence of viral pneumonia-associated changes on sequential chest CT scans in hospitalized patients |
| Laboratory abnormalities | 28 days post-randomization | Occurrence of laboratory hematimetric parameters, creatinine, d-dimer, c-reactive protein |
| Adverse events | 28 days post-randomization | Incidence of adverse events related to the use of the investigational products |
Countries
Russia
Contacts
Primary ContactSergey Lukyanov, MD
Outcome results
None listed