Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Milan | OTHER |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
Not provided
Not provided
Not provided
Not provided
The main aim of the study is to estimate the potential efficacy of i.v. canrenone as add-on therapy on maximal medical treatment versus maximal medical treatment alone in treating moderate-to-severe ARDS due to SARS-CoV-2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference group | No Intervention | Patients randomized to the Reference Group will receive the standard-of-care treatments, according to institutional procedures in force:
| |
| Experimental Group | Experimental | Patients randomized in the Experimental Group will receive canrenone as add-on therapy to standard-of-care treatments. Different starting doses of i.v. canrenone will be administrated in a single or double infusion per day, for 7 days, according to the serum concentration of potassium at randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Canrenoate | Drug | potassium canrenoate for 7 days in addition to maximal medical treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| in-hospital death | patients discharged to a long-term care facility will be classified as "discharged alive" | At the event (discharge or death) |
| Measure | Description | Time Frame |
|---|---|---|
| Need of invasive mechanical ventilation throughout hospitalization | Researchers will record if mechanical ventilation has been required during hospitalization (YES) or not (NO) | at discharge or death |
| Duration of hospitalization for alive patients |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Vicenzi, MD | Contact | +390255033537 | marco.vicenzi@policlinico.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Marco Vicenzi, MD | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D002191 | Canrenoic Acid |
| D002192 | Canrenone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Open label, 1:1 randomized parallel arms, Simon's two stage design, single centre.
Not provided
Not provided
Not provided
Not provided
from randomization to discharge
| From date of randomization until the date discharge or in-hospital death from any cause, whichever came first, assessed up to 48 months |
| Drug intolerance | measured as number of AR and SAR | From the date of randomization until three days after the end of IMP administration (10 days after randomization) |
| Number of hypotensive events | defined as systolic blood pressure constantly <90 mmHg and diastolic blood pressure constantly <60 mmHg) | From the date of randomization until three days after the end of IMP administration (10 days after randomization) |
| Number of hyperkaliemias events | defined as [K+]hematic >5.1 mEq/L | From the date of randomization until three days after the end of IMP administration (10 days after randomization) |
| Number of renal failures | defined as eGFR <30 ml/min | From the date of randomization until three days after the end of IMP administration (10 days after randomization) |
| Change in Sequential Organ Failure Assessment (SOFA) score from randomization to 7 days after randomization | A score from 0 (better outcome) to 4 (worst outcome) for six different systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems) will be assessed and recorded in CRF | 7 days after randomization |
| Change in inflammatory status | CRP levels, IL-6, Ddimer and Ferritin | at 48 hours and 168 hours (7th day) from randomization |
| Change in respiratory parameters | Heart Rate, Blood Pressure (mmHg), PaO2/FiO2 (mmHg), alveolar-arterial gradient (mmHg) | at 48 hours and 168 hours (7th day) from randomization |
| Changes in features of pulmonary interstitial disease measured by chest X-Ray | at 7 days after randomization |
| Changes in [K+]hematic, renin, AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids | [K+]hematic will be expressed as mEq/L Plasmatic Renin Activity will be expressed as µUI/mL Hematic Concentration of AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids will be expressed as ng/mL | at randomization and at 48 and 168 hours (7th day) from randomization |
| Correlation between levels of [K+]hematic, renin, AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids, at basal level (randomization) and clinical outcomes (in-hospital death, need of invasive mechanical ventilation, SOFA score) | [K+]hematic will be expressed as mEq/L Plasmatic Renin Activity will be expressed as µUI/mL Hematic Concentration of AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids will be expressed as ng/mL | at randomization and at 48 and 168 hours (7th day) from randomization |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011083 |
| Polycyclic Compounds |