COVID-19 Pneumonia
Conditions
Keywords
COVID-19, spironolactone, pneumonia, fibrosis, SARS-CoV-2, potassium canrenoate
Brief summary
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.
Interventions
DRUGCanrenoate Potassium
Intervention: 200 mg of Canrenoate potassium in 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
DRUGNormal Saline
Placebo: 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
Sponsors
Pomeranian Medical University Szczecin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of both sexes, 18-90 years of age. 2. Patient requiring oxygen therapy, SpO2 \<94%. 3. Confirmed COVID-19 infection. 4. At least one risk factor for increased mortality in the course of COVID-19: currently published in the literature e.g. smoking, hypertension, diabetes, cardiovascular disease. 5. Documented informed consent according to ICH-GCP and national regulations.
Exclusion criteria
1. Chronic bronchitis, emphysema, interstitial lung disease, or other history of lung disease. 2. Contraindications to the use of spironolactone. 3. Hypersensitivity to spironolactone or any of the excipients. 4. Pregnant patients (pregnancy test will be performed in every patient of reproductive age) and during lactation. 5. Patients with mental illness or dementia who are unable to give informed consent to the examination. 6. ARDS caused by another viral infection (SARS-CoV-2 negative). 7. ARDS from other causes/trauma. 8. Ionic disorders: hyperkalemia, hyponatraemia. 9. Adrenal crisis. 10. Acute and chronic renal failure, creatinine clearance less than 30 ml/min. 11. Anuria. 12. Porphyria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical ventilation | 30 days | Duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy |
| Passive oxygen therapy | 30 days | Duration of passive oxygen therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest CT | 90 days | Assessment of the dynamics of recovery of changes in chest CT at 3 months. |
| Lung ultrasound_7 | 7 days | Assessment of the dynamics of recovery of changes in lung ultrasound at 7 days. |
| Lung ultrasound_30 | 30 days | Assessment of the dynamics of recovery of changes in lung ultrasound at 30 days. |
| Mortality_30 | 30 days | Assessment of mortality at 30 days. |
| Mortality_90 | 90 days | Assessment of mortality at 90 days. |
| ICU LOS | 30 days | Intensive Care Unit length of stay (LOS). |
| IL-2 level change. | 7 days | Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-2. |
| IL-6 level change. | 7 days | Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-6. |
| IL-33 level change. | 7 days | Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-33. |
| TNFα level change. | 7 days | Evaluation of the degree of change of the level of pro-inflammatory cytokine TNFα. |
| 6MWT | 30 days | Six minute walk test. |
| IL-1β level change. | 7 days | Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-1β. |
| Hospital LOS | 90 days | Total hospital length of stay (LOS). |
Countries
Poland
Contacts
Primary ContactKatarzyna L Kotfis, MD, PhD
Outcome results
None listed