Status:
UNKNOWN
BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization
Lead Sponsor:
Lomonosov Moscow State University Medical Research and Educational Center
Conditions:
COVID 19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 23 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04424134
Start Date
May 16 2020
End Date
August 23 2020
Last Update
June 9 2020
Active Locations (1)
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1
Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Moscow Oblast, Russia, 119620