Coronavirus Infection Clinical Trial
— SPIDEX-IIOfficial title:
Spironolactone and Dexamethasone in Patients Hospitalized With Moderate-to-severe COVID-19 (SPIDEX-II): a Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 440 |
Est. completion date | September 2, 2021 |
Est. primary completion date | July 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Chita State Regional Clinical Hospital Number 1 | Chita |
Lead Sponsor | Collaborator |
---|---|
Chita State Regional Clinical Hospital Number 1 |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Incidence of adverse events related to the use of the investigational products | 28 days post-randomization | |
Other | Laboratory abnormalities | Occurrence of laboratory hematimetric parameters, creatinine, d-dimer, c-reactive protein | 28 days post-randomization | |
Other | Change in classic cough score | Change in classic cough score measured daily in hospitalized patients | 28 days post-randomization | |
Other | Radiological abnormalities | Occurrence of viral pneumonia-associated changes on sequential chest CT scans in hospitalized patients | 28 days post-randomization | |
Primary | 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) | Day 14 post-randomization | |
Secondary | 28-day all-cause mortality | All-cause mortality at 28 days post-randomization | 28 days post-randomization | |
Secondary | Oxygen-free days | The number of days without oxygen support of any type | 28 days post-randomization | |
Secondary | Ventilator-free days | The number of days without invasive mechanical ventilation | 28 days post-randomization | |
Secondary | Invasive mechanical ventilation | The number of patients requiring invasive mechanical ventilation during hospitalization and the number of days spent on newly-administered invasive mechanical ventilation | 28 days post-randomization | |
Secondary | Time to discharge | The number of days from hospitalization to discharge | 28 days post-randomization | |
Secondary | Length of ICU stay | The number of days spent in the intensive care unit | 28 days post-randomization | |
Secondary | New ICU admission | The number of patients requiring transfer to ICU and the number of days spent in the ICU post-transfer | 28 days post-randomization | |
Secondary | Long-COVID development | 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) | 60 and 90 days post-admission | |
Secondary | Evaluation of the clinical status | Clinical status at day 7 post-randomization defined by a 6-point ordinal scale score (6 being the worst score) | Day 7 post-randomization |
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