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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone + Dexamethasone | Drug | Low doses of orally administered spironolactone and dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality | All-cause mortality at 28 days post-randomization | 28 days post-randomization |
| Oxygen-free days | The number of days without oxygen support of any type |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence of adverse events related to the use of the investigational products | 28 days post-randomization |
| Laboratory abnormalities | Occurrence of laboratory hematimetric parameters, creatinine, d-dimer, c-reactive protein |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergey Lukyanov, MD | Contact | +79242772971 | lukyanov-sergei@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Sergey Lukyanov, MD | Chita State Regional Clinical Hospital Number 1 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chita State Regional Clinical Hospital Number 1 | Recruiting | Chita | 672039 | Russia |
Sharing IPD would require material transfer agreement according to the local rules and regulations. The study protocol, statistical analysis plan, and the translated version of the informed consent form can be shared upon request.
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Standard-of-care SARS-CoV-2 treatment | Drug | Standard-of-care SARS-CoV-2 treatment administered according to the local guidelines |
|
| 28 days post-randomization |
| Ventilator-free days | The number of days without invasive mechanical ventilation | 28 days post-randomization |
| 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 |
| Time to discharge | The number of days from hospitalization to discharge | 28 days post-randomization |
| Length of ICU stay | The number of days spent in the intensive care unit | 28 days post-randomization |
| 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 |
| 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 |
| 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 |
| 28 days post-randomization |
| Change in classic cough score | Change in classic cough score measured daily in hospitalized patients | 28 days post-randomization |
| Radiological abnormalities | Occurrence of viral pneumonia-associated changes on sequential chest CT scans in hospitalized patients | 28 days post-randomization |
| D007239 |
| Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D013259 | Steroids, Fluorinated |