BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization (BISCUIT)

Lomonosov Moscow State University Medical Research and Educational Center

Status and phase

Unknown

Phase 3

Conditions

COVID 19

Treatments

Drug: Bromhexine and Spironolactone

Drug: Base therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04424134

MSU160520

Details and patient eligibility

About

Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

signed inform consent COVID 19 with the mild and severe course. The diagnosis could be made with positive polymerase chain reaction (PCR) (International Statistical Classification (ICD-10) code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2) 5. Lung exposure on CT more than 25% 6. Sp02 without supportive oxygen ≤ 93% 7. C-reactive protein > 60 mg/l or elevation of C reactive protein 3 times in 8-14 days after first symptoms

Exclusion criteria

pregnancy and breastfeeding
hypersensitivity to Spironolactone
hypersensitivity to Bromhexine
Known liver failure
Glomerular filtration rate <20 ml/ min
physician judgment that the patient will need mechanical ventilation in 24 hours
other indications for Spironolactone
Active cancer