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Mineralocorticoid Receptor Antagonist and Pulmonary Fibrosis in COVID-19. (SpiroCOVID19)

3. juni 2021 opdateret af: Katarzyna Kotfis, Pomeranian Medical University Szczecin

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Polen
      • Szczecin, Polen, 70-111
        • Rekruttering
        • Pomeranian Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Canrenoate potassium
Administration of 200 mg of potassium Canrenoate potassium dissolved in 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.
Medicin: Canrenoate Potassium
Intervention: 200 mg of Canrenoate potassium in 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
Andre navne:
  • Undersøgelsesprodukt
Placebo komparator: Placebo
Administration of 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.
Medicin: Normal Saline
Placebo: 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
Andre navne:
  • Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mechanical ventilation
Tidsramme: 30 days
Duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy
30 days
Passive oxygen therapy
Tidsramme: 30 days
Duration of passive oxygen therapy
30 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICU LOS
Tidsramme: 30 days
Intensive Care Unit length of stay (LOS).
30 days
Hospital LOS
Tidsramme: 90 days
Total hospital length of stay (LOS).
90 days
Chest CT
Tidsramme: 90 days
Assessment of the dynamics of recovery of changes in chest CT at 3 months.
90 days
Lung ultrasound_7
Tidsramme: 7 days
Assessment of the dynamics of recovery of changes in lung ultrasound at 7 days.
7 days
Lung ultrasound_30
Tidsramme: 30 days
Assessment of the dynamics of recovery of changes in lung ultrasound at 30 days.
30 days
Mortality_30
Tidsramme: 30 days
Assessment of mortality at 30 days.
30 days
Mortality_90
Tidsramme: 90 days
Assessment of mortality at 90 days.
90 days
IL-1β level change.
Tidsramme: 7 days
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-1β.
7 days
IL-2 level change.
Tidsramme: 7 days
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-2.
7 days
IL-6 level change.
Tidsramme: 7 days
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-6.
7 days
IL-33 level change.
Tidsramme: 7 days
Evaluation of the degree of change of the level of pro-inflammatory cytokine IL-33.
7 days
TNFα level change.
Tidsramme: 7 days
Evaluation of the degree of change of the level of pro-inflammatory cytokine TNFα.
7 days
6MWT
Tidsramme: 30 days
Six minute walk test.
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pomeranian Medical University Szczecin

Efterforskere

  • Ledende efterforsker: Katarzyna L Kotfis, MD, PhD, Pomeranian Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2021

Primær færdiggørelse (Forventet)

31. august 2021

Studieafslutning (Forventet)

31. december 2021

Datoer for studieregistrering

Først indsendt

1. juni 2021

Først indsendt, der opfyldte QC-kriterier

2. juni 2021

Først opslået (Faktiske)

3. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0012/100/2020

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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