Mineralocorticoid Receptor Antagonist and Pulmonary Fibrosis in COVID-19.

NCT04912011 | Unknown Phase 4

• 1 other identifier: 0012/100/2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia

Keywords

COVID-19; spironolactone; pneumonia; fibrosis; SARS-CoV-2; potassium canrenoate

Outcome Measures

Primary Outcomes (2)

• Mechanical ventilation

  Duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy

  30 days

• Passive oxygen therapy

  Duration of passive oxygen therapy

  30 days

Secondary Outcomes (13)

• ICU LOS

  30 days

• Hospital LOS

  90 days

• Chest CT

  90 days

• Lung ultrasound_7

  7 days

• Lung ultrasound_30

  30 days

Study Arms (2)

Canrenoate potassium

EXPERIMENTAL

Administration of 200 mg of potassium Canrenoate potassium dissolved in 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.

Drug: Canrenoate Potassium

Placebo

PLACEBO COMPARATOR

Administration of 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.

Drug: Normal Saline

Interventions

Canrenoate Potassium DRUG

Intervention: 200 mg of Canrenoate potassium in 100 ml 0,9% NaCl, intravenously twice a day for 7 days.

Also known as: Investigational Product

Canrenoate potassium

Normal Saline DRUG

Placebo: 100 ml 0,9% NaCl, intravenously twice a day for 7 days.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Pomeranian Medical University

Szczecin, 70-111, Poland

RECRUITING

Related Publications (2)

• 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.

  PMID: 32575380 BACKGROUND

• 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.

  PMID: 33477294 BACKGROUND

MeSH Terms

Conditions

COVID-19; Pneumonia; Fibrosis

Interventions

Canrenoic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Katarzyna L Kotfis, MD, PhD

  Pomeranian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna L Kotfis, MD, PhD

CONTACT

0048602449202; katarzyna.kotfis@pum.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 3, 2021
• Study Start: January 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)