In December 2019 SARS-CoV-2 virus appeared in the world, mainly appearing as an acute infection of the lower respiratory tract. In March 2020, the World Health Organization (WHO) announced a pandemic in relation to the disease caused by the SARS-CoV-2 virus, known as COronaVIrus Disease 2019 (COVID-19). Since then, the efforts of scientists from around the world have focused on finding the right treatment and vaccine for the new disease. COVID-19 has spread rapidly in a few months, affecting patients in all ages. The disease has a varied course, patients can be 80% asymptomatic, but many develop respiratory failure, complicated by sepsis and ultimately death. One of the possible complications associated with COVID-19 lung involvement is pulmonary fibrosis, leading to chronic breathing difficulties and prolonged disability. No specific mechanisms leading to this phenomenon have been identified in COVID-19, but some information is derived from previous studies on the SARS and MERS epidemic. There have been several reports that the use of spironolactone may be important in preventing pulmonary fibrosis. The aim of the study is to evaluate the effectiveness of intravenous form of mineralocorticoid receptor antagonist canrenoate potassium (an aldosterone antagonist of the spirolactone group) in the treatment of COVID-19-associated pulmonary fibrosis based on the mechanisms of the immune response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Intervention: 200 mg of Canrenoate potassium in 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
Placebo: 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
Pomeranian Medical University
Szczecin, Poland
RECRUITINGMechanical ventilation
Duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy
Time frame: 30 days
Passive oxygen therapy
Duration of passive oxygen therapy
Time frame: 30 days
ICU LOS
Intensive Care Unit length of stay (LOS).
Time frame: 30 days
Hospital LOS
Total hospital length of stay (LOS).
Time frame: 90 days
Chest CT
Assessment of the dynamics of recovery of changes in chest CT at 3 months.
Time frame: 90 days
Lung ultrasound_7
Assessment of the dynamics of recovery of changes in lung ultrasound at 7 days.
Time frame: 7 days
Lung ultrasound_30
Assessment of the dynamics of recovery of changes in lung ultrasound at 30 days.
Time frame: 30 days
Mortality_30
Assessment of mortality at 30 days.
Time frame: 30 days
Mortality_90
Assessment of mortality at 90 days.
Time frame: 90 days
IL-1β level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-1β.
Time frame: 7 days
IL-2 level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-2.
Time frame: 7 days
IL-6 level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-6.
Time frame: 7 days
IL-33 level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-33.
Time frame: 7 days
TNFα level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine TNFα.
Time frame: 7 days
6MWT
Six minute walk test.
Time frame: 30 days
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