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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04826822
Other study ID # SPII_1789461
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 24, 2021
Est. completion date September 2, 2021

Study information

Verified date March 2021
Source Chita State Regional Clinical Hospital Number 1
Contact Sergey Lukyanov, MD
Phone +79242772971
Email lukyanov-sergei@mail.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) is a rapidly spreading infection of the respiratory tract. Most infected patients have either asymptomatic disease or mild symptoms. However, a proportion of patients, especially elderly men or patients with comorbidities, are at risk of developing acute respiratory distress syndrome (ARDS). ARDS, alongside clotting abnormalities, is known to be a major contributor to SARS-CoV-2-related mortality and admission to intensive care units, with evidenced effective preventative treatment options lacking. In this study, the investigators test a novel hypothesis that the use of a combination of spironolactone and dexamethasone at low doses will improve the clinical progression of the infection evaluated by the 6-point ordinal scale in patients with moderate and severe disease by blocking exocytosis of the Weibel-Palade bodies from endothelial cells.


Recruitment information / eligibility

Status Recruiting
Enrollment 440
Est. completion date September 2, 2021
Est. primary completion date July 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years or above; - Signed informed consent; - PCR-confirmed diagnosis of SARS-CoV-2 infection - Presenting with moderate-to-severe disease (scores 4-6 on WHO ordinal scale) Exclusion Criteria: - Women of childbearing age without a negative urine pregnancy test, currently pregnant or breastfeeding women; - Severe heart failure (NYHA4), severe renal failure (eGFR < 30 ml/min/1.73 m2), severe liver failure (ALT/AST ratio > 5 norms), severe anemia (haemoglobin < 30 g/l) - Participating in another clinical trial - Severe electrolyte imbalance (hyperkalemia > 5.0 mmol/l, hyponatremia < 120 mmol/l) - Hypersensitivity or contraindications to the study drugs (spironolactone and dexamethasone) - Renal dialysis - Severe uncontrolled diabetes mellitus - Patient receiving one of the following medications that cannot be substituted over the trial duration: ACE inhibitors, amiloride, eplerenone, cortisone acetate, potassium canrenoate, triamterene

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Spironolactone + Dexamethasone
Low doses of orally administered spironolactone and dexamethasone
Standard-of-care SARS-CoV-2 treatment
Standard-of-care SARS-CoV-2 treatment administered according to the local guidelines

Locations

Country Name City State
Russian Federation Chita State Regional Clinical Hospital Number 1 Chita

Sponsors (1)

Lead Sponsor Collaborator
Chita State Regional Clinical Hospital Number 1

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events Incidence of adverse events related to the use of the investigational products 28 days post-randomization
Other Laboratory abnormalities Occurrence of laboratory hematimetric parameters, creatinine, d-dimer, c-reactive protein 28 days post-randomization
Other Change in classic cough score Change in classic cough score measured daily in hospitalized patients 28 days post-randomization
Other Radiological abnormalities Occurrence of viral pneumonia-associated changes on sequential chest CT scans in hospitalized patients 28 days post-randomization
Primary Evaluation of the clinical status Clinical status at day 14 post-randomization defined by a 6-point ordinal scale score (6 being the worst score) Day 14 post-randomization
Secondary 28-day all-cause mortality All-cause mortality at 28 days post-randomization 28 days post-randomization
Secondary Oxygen-free days The number of days without oxygen support of any type 28 days post-randomization
Secondary Ventilator-free days The number of days without invasive mechanical ventilation 28 days post-randomization
Secondary Invasive mechanical ventilation The number of patients requiring invasive mechanical ventilation during hospitalization and the number of days spent on newly-administered invasive mechanical ventilation 28 days post-randomization
Secondary Time to discharge The number of days from hospitalization to discharge 28 days post-randomization
Secondary Length of ICU stay The number of days spent in the intensive care unit 28 days post-randomization
Secondary New ICU admission The number of patients requiring transfer to ICU and the number of days spent in the ICU post-transfer 28 days post-randomization
Secondary Long-COVID development The number of patients with signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis (Post-COVID-19 syndrome as defined by the relevant NICE guidance) 60 and 90 days post-admission
Secondary Evaluation of the clinical status Clinical status at day 7 post-randomization defined by a 6-point ordinal scale score (6 being the worst score) Day 7 post-randomization
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