Efficacy of Canrenone as add-on Treatment in Moderate to Severe ARDS in COVID-19

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Interventions

Potassium CanrenoateDRUG

potassium canrenoate for 7 days in addition to maximal medical treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 - 80 y.o. Since over eighties are very fragile patients, a lot of confounding unpredictable events may interfere with the trial analyses; thus, these patients will be excluded from this exploratory proof-of-concept trial; * COVID-19 diagnosis through swab within 14 days from the beginning of symptoms * Hospitalization for moderate to severe ARDS (as determined by PaO2/FiO2 ≤300 mmHg at admission) * Serum concentration of potassium ≤4.5 mEq/L * Consent to participate Exclusion Criteria: * Invasive mechanical ventilation * I.v. hydratation with Darrow's solution or half-strength Darrow's solution underway * Acute cardiovascular event (acute myocardial infarction, acute ischaemic stroke) * Current malignant disease * Creatinine \>1.8 mg/dL (for women) and \>2.0 mg/dL (for men) or glomerular filtration rate \<50 mL/mm * Systolic blood pressure \<110 mmHg and/or diastolic blood pressure \<60 mmHg * Known or suspected hypersensitivity to canrenone * Hyponatremia * Anuria * Familial history of porphyria * Pregnancy and breastfeeding * known or suspected hypersensitivity to canrenone * Inclusion in any other pharmacological clinical trials

Outcomes

Primary Outcomes

in-hospital death

patients discharged to a long-term care facility will be classified as "discharged alive"

Time frame: At the event (discharge or death)

Secondary Outcomes

Need of invasive mechanical ventilation throughout hospitalization

Researchers will record if mechanical ventilation has been required during hospitalization (YES) or not (NO)

Time frame: at discharge or death

Duration of hospitalization for alive patients

from randomization to discharge

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: From the date of randomization until three days after the end of IMP administration (10 days after randomization)

Central Contacts

Marco Vicenzi, MD

CONTACT

+390255033537 marco.vicenzi@policlinico.mi.it

Data from ClinicalTrials.gov

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