Mineralocorticoid Receptor Antagonist and Pulmonary Fibrosis in COVID-19. (SpiroCOVID19)
Primary Purpose
COVID-19 Pneumonia
Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Canrenoate Potassium
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring COVID-19, spironolactone, pneumonia, fibrosis, SARS-CoV-2, potassium canrenoate
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes, 18-90 years of age.
- Patient requiring oxygen therapy, SpO2 <94%.
- Confirmed COVID-19 infection.
- 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.
- Documented informed consent according to ICH-GCP and national regulations.
Exclusion Criteria:
- Chronic bronchitis, emphysema, interstitial lung disease, or other history of lung disease.
- Contraindications to the use of spironolactone.
- Hypersensitivity to spironolactone or any of the excipients.
- Pregnant patients (pregnancy test will be performed in every patient of reproductive age) and during lactation.
- Patients with mental illness or dementia who are unable to give informed consent to the examination.
- ARDS caused by another viral infection (SARS-CoV-2 negative).
- ARDS from other causes/trauma.
- Ionic disorders: hyperkalemia, hyponatraemia.
- Adrenal crisis.
- Acute and chronic renal failure, creatinine clearance less than 30 ml/min.
- Anuria.
- Porphyria.
Sites / Locations
- Pomeranian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Canrenoate potassium
Placebo
Arm Description
Administration of 200 mg of potassium Canrenoate potassium dissolved in 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.
Administration of 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.
Outcomes
Primary Outcome Measures
Mechanical ventilation
Duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy
Passive oxygen therapy
Duration of passive oxygen therapy
Secondary Outcome Measures
ICU LOS
Intensive Care Unit length of stay (LOS).
Hospital LOS
Total hospital length of stay (LOS).
Chest CT
Assessment of the dynamics of recovery of changes in chest CT at 3 months.
Lung ultrasound_7
Assessment of the dynamics of recovery of changes in lung ultrasound at 7 days.
Lung ultrasound_30
Assessment of the dynamics of recovery of changes in lung ultrasound at 30 days.
Mortality_30
Assessment of mortality at 30 days.
Mortality_90
Assessment of mortality at 90 days.
IL-1β level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-1β.
IL-2 level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-2.
IL-6 level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-6.
IL-33 level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-33.
TNFα level change.
Evaluation of the degree of change of the level of pro-inflammatory cytokine TNFα.
6MWT
Six minute walk test.
Full Information
NCT ID
NCT04912011
First Posted
June 1, 2021
Last Updated
June 3, 2021
Sponsor
Pomeranian Medical University Szczecin
1. Study Identification
Unique Protocol Identification Number
NCT04912011
Brief Title
Mineralocorticoid Receptor Antagonist and Pulmonary Fibrosis in COVID-19.
Acronym
SpiroCOVID19
Official Title
The Use of a Mineralocorticoid Receptor Antagonist (Spironolactone) in the Treatment of Pulmonary Fibrosis Associated With SARS-CoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pomeranian Medical University Szczecin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
COVID-19, spironolactone, pneumonia, fibrosis, SARS-CoV-2, potassium canrenoate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Canrenoate potassium
Arm Type
Experimental
Arm Description
Administration of 200 mg of potassium Canrenoate potassium dissolved in 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administration of 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.
Intervention Type
Drug
Intervention Name(s)
Canrenoate Potassium
Other Intervention Name(s)
Investigational Product
Intervention Description
Intervention: 200 mg of Canrenoate potassium in 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Placebo
Intervention Description
Placebo: 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
Primary Outcome Measure Information:
Title
Mechanical ventilation
Description
Duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy
Time Frame
30 days
Title
Passive oxygen therapy
Description
Duration of passive oxygen therapy
Time Frame
30 days
Secondary Outcome Measure Information:
Title
ICU LOS
Description
Intensive Care Unit length of stay (LOS).
Time Frame
30 days
Title
Hospital LOS
Description
Total hospital length of stay (LOS).
Time Frame
90 days
Title
Chest CT
Description
Assessment of the dynamics of recovery of changes in chest CT at 3 months.
Time Frame
90 days
Title
Lung ultrasound_7
Description
Assessment of the dynamics of recovery of changes in lung ultrasound at 7 days.
Time Frame
7 days
Title
Lung ultrasound_30
Description
Assessment of the dynamics of recovery of changes in lung ultrasound at 30 days.
Time Frame
30 days
Title
Mortality_30
Description
Assessment of mortality at 30 days.
Time Frame
30 days
Title
Mortality_90
Description
Assessment of mortality at 90 days.
Time Frame
90 days
Title
IL-1β level change.
Description
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-1β.
Time Frame
7 days
Title
IL-2 level change.
Description
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-2.
Time Frame
7 days
Title
IL-6 level change.
Description
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-6.
Time Frame
7 days
Title
IL-33 level change.
Description
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-33.
Time Frame
7 days
Title
TNFα level change.
Description
Evaluation of the degree of change of the level of pro-inflammatory cytokine TNFα.
Time Frame
7 days
Title
6MWT
Description
Six minute walk test.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes, 18-90 years of age.
Patient requiring oxygen therapy, SpO2 <94%.
Confirmed COVID-19 infection.
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.
Documented informed consent according to ICH-GCP and national regulations.
Exclusion Criteria:
Chronic bronchitis, emphysema, interstitial lung disease, or other history of lung disease.
Contraindications to the use of spironolactone.
Hypersensitivity to spironolactone or any of the excipients.
Pregnant patients (pregnancy test will be performed in every patient of reproductive age) and during lactation.
Patients with mental illness or dementia who are unable to give informed consent to the examination.
ARDS caused by another viral infection (SARS-CoV-2 negative).
ARDS from other causes/trauma.
Ionic disorders: hyperkalemia, hyponatraemia.
Adrenal crisis.
Acute and chronic renal failure, creatinine clearance less than 30 ml/min.
Anuria.
Porphyria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna L Kotfis, MD, PhD
Phone
0048602449202
Email
katarzyna.kotfis@pum.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna L Kotfis, MD, PhD
Organizational Affiliation
Pomeranian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pomeranian Medical University
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna L Kotfis, MD
Phone
0048914661144
Email
katarzyna.kotfis@pum.edu.pl
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32575380
Citation
Lechowicz K, Drozdzal S, Machaj F, Rosik J, Szostak B, Zegan-Baranska M, Biernawska J, Dabrowski W, Rotter I, Kotfis K. COVID-19: The Potential Treatment of Pulmonary Fibrosis Associated with SARS-CoV-2 Infection. J Clin Med. 2020 Jun 19;9(6):1917. doi: 10.3390/jcm9061917.
Results Reference
background
PubMed Identifier
33477294
Citation
Kotfis K, Lechowicz K, Drozdzal S, Niedzwiedzka-Rystwej P, Wojdacz TK, Grywalska E, Biernawska J, Wisniewska M, Parczewski M. COVID-19-The Potential Beneficial Therapeutic Effects of Spironolactone during SARS-CoV-2 Infection. Pharmaceuticals (Basel). 2021 Jan 17;14(1):71. doi: 10.3390/ph14010071.
Results Reference
background
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Mineralocorticoid Receptor Antagonist and Pulmonary Fibrosis in COVID-19.
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