Mineralocorticoid Receptor Antagonist and Pulmonary Fibrosis in COVID-19.

COVID-19 Pneumonia Clinical Trial

— SpiroCOVID19  

Official title:

The Use of a Mineralocorticoid Receptor Antagonist (Spironolactone) in the Treatment of Pulmonary Fibrosis Associated With SARS-CoV-2 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04912011
• Other study ID #: 0012/100/2020
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2021
• Source: Pomeranian Medical University Szczecin
• Contact: Katarzyna L Kotfis, MD, PhD
• Phone: 0048602449202
• Email: katarzyna.kotfis[@]pum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Fibrosis
• Pneumonia
• Pulmonary Fibrosis

Intervention

Drug:
• Canrenoate Potassium
Intervention: 200 mg of Canrenoate potassium in 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
• Normal Saline
Placebo: 100 ml 0,9% NaCl, intravenously twice a day for 7 days.

Locations

Country	Name	City	State
Poland	Pomeranian Medical University	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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). pii: 71. doi: 10.3390/ph14010071. Review. — View 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). pii: E1917. doi: 10.3390/jcm9061917. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical ventilation	Duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy	30 days
Primary	Passive oxygen therapy	Duration of passive oxygen therapy	30 days
Secondary	ICU LOS	Intensive Care Unit length of stay (LOS).	30 days
Secondary	Hospital LOS	Total hospital length of stay (LOS).	90 days
Secondary	Chest CT	Assessment of the dynamics of recovery of changes in chest CT at 3 months.	90 days
Secondary	Lung ultrasound_7	Assessment of the dynamics of recovery of changes in lung ultrasound at 7 days.	7 days
Secondary	Lung ultrasound_30	Assessment of the dynamics of recovery of changes in lung ultrasound at 30 days.	30 days
Secondary	Mortality_30	Assessment of mortality at 30 days.	30 days
Secondary	Mortality_90	Assessment of mortality at 90 days.	90 days
Secondary	IL-1ß level change.	Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-1ß.	7 days
Secondary	IL-2 level change.	Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-2.	7 days
Secondary	IL-6 level change.	Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-6.	7 days
Secondary	IL-33 level change.	Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-33.	7 days
Secondary	TNFa level change.	Evaluation of the degree of change of the level of pro-inflammatory cytokine TNFa.	7 days
Secondary	6MWT	Six minute walk test.	30 days