BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

• Status: Recruiting
• Trial end date: 2020-08-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lomonosov Moscow State University Medical Research and Educational Center
• Treatments: Bromhexine; Spironolactone

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