Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19

NCT ID: NCT04826822

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-24
• Study Completion Date: 2021-09-02

Brief 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.

Conditions

Coronavirus Infection; Pneumonia, Viral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

After randomisation (Day 1): Spironolactone [100 mg 1x/day] + dexamethasone [2 mg 2x/day, 12/12h] Days 2-12*: Spironolactone [50 mg 2x/day, 12/12h] + dexamethasone [2 mg 2x/day, 12/12h] Days 13-20: Spironolactone [25 mg 2x/day, 12/12h] Days 21-28: Spironolactone [25 mg 1x/day] Standard treatment is according to the treatment protocol for 2019-nCoV infection.

*In case of cortisol levels above 100 nmol/L on days 3 and 4, the dexamethasone dose should be increased to 3 mg in the morning and in the evening (total 6 mg per day).

Group Type: EXPERIMENTAL

Spironolactone + Dexamethasone

Intervention Type: DRUG

Low doses of orally administered spironolactone and dexamethasone

Control

Patients receiving standard-of-care treatment for SARS-CoV-2 infection as regulated by the relevant guidelines of the Ministry of Healthcare of the Russian Federation

Group Type: ACTIVE_COMPARATOR

Standard-of-care SARS-CoV-2 treatment

Intervention Type: DRUG

Standard-of-care SARS-CoV-2 treatment administered according to the local guidelines

Interventions

Spironolactone + Dexamethasone

Low doses of orally administered spironolactone and dexamethasone

Intervention Type: DRUG

Standard-of-care SARS-CoV-2 treatment

Standard-of-care SARS-CoV-2 treatment administered according to the local guidelines

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chita State Regional Clinical Hospital Number 1

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergey Lukyanov, MD

Role: PRINCIPAL_INVESTIGATOR

Chita State Regional Clinical Hospital Number 1

Locations

Chita State Regional Clinical Hospital Number 1

Chita, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Sergey Lukyanov, MD

Role: CONTACT

lukyanov-sergei@mail.ru

+79242772971

Facility Contacts

Sergey Lukyanov, MD

Role: primary

lukyanov-sergei@mail.ru

+7 924 277-29-71

Other Identifiers

SPII_1789461

Identifier Type: -

Identifier Source: org_study_id