Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19

Coronavirus Infection Clinical Trial

— SPIDEX-II  

Official title:

Spironolactone and Dexamethasone in Patients Hospitalized With Moderate-to-severe COVID-19 (SPIDEX-II): a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826822
• Other study ID #: SPII_1789461
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Pneumonia
• Pneumonia, Viral
• Severe Acute Respiratory Syndrome

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