Official Title
Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
Brief Summary

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.

Unknown status
COVID 19

Drug: Bromhexine and Spironolactone

Bromhexine 8 mg x 4 times a day x 10 days Spironolactone 50 mg x once a day x 10 days

Drug: Base therapy

Therapy currently recommended by Ministry of Health of Russian Federation for COVID 19 treatment

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Russian Federation
Locations

Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Moscow Region, Russian Federation

Investigator: Julia Begrambekova, Phd
Contact: +79854679273
begrambekova@ossn.ru

Contacts

Julia Begrambekova
+79854679273
julia.begrambekova@ossn.ru

Lomonosov Moscow State University Medical Research and Educational Center
NCT Number
Keywords
COVID 19
BROMHEXINE
spironolactone
MeSH Terms
COVID-19
Coronavirus Infections
Spironolactone
Bromhexine